AGE or AGETXT variable must be present At least one of Age (AGE) or Age Text (AGETXT) variables should be inculded into Demographics (DM) domain 3.0 3.1 DM Neither AGE nor AGETXT variables are present ]]> AGE or AGETXT variables values must be populated Value for Age (AGE) of Age Range (AGETXT) variables should be populated for all subjects with only exception for Screen Failures (ARMCD=SCRNFAIL) and Not Assigned (ARMCD=NOTASSGN) subjects 3.0 3.1 DM Neither of AGE or AGETXT variables values are populated ]]> AGE must be provided Age (AGE) variable values should be provided, when Date/Time of Birth (BRTHDTC) variable values are populated 3.0 3.1 DM AGE is not provided ]]> Age or age range must be provided for all subjects, except for Screen Failures 'Age' (AGE) or 'Age Text' (AGETXT) records must be populated in Trial Summary (TS) domain 3.0 3.1 TS No PARAMCD=AGE nor PARAMCD=AGETXT record was found ]]> AGE and AGETXT variables values may not be both populated Age (AGE) and Age Range (AGETXT) variables should never both be populated for the same subject 3.0 3.1 DM Both AGE and AGETXT variables values are populated ]]> ECSTDTC/EXSTDTC date may not be before RFXSTDTC Start Date/Time of Treatment (EXSTDTC) variable value must be greater than or equal to Date/Time of First Study Treatment (RFXSTDTC) 3.1 EX EC {data($usubjoid)} - {data($rfxstdtcoid)}):) (: create a temporary structure containing USUBJID and RFXSTDTC :) let $usubjidrfxstdtcpairs := ( for $record in doc($dmdataset)//odm:ItemGroupData let $usubjid := $record/odm:ItemData[@ItemOID=$usubjoiddm]/@Value let $rfxstdtc := $record/odm:ItemData[@ItemOID=$rfxstdtcoid]/@Value return ) (: get the OID of EXSTDTC or EGSTDTC :) let $stdtcname := concat($datasetname,'STDTC') let $stdtcoid := ( for $a in $definedoc//odm:ItemDef[@Name=$stdtcname]/@OID where $a = $definedoc//odm:ItemGroupDef[@Name=$datasetname]/odm:ItemRef/@ItemOID return $a ) (: get the OID of USUBJID in EX or EC :) let $usubjidoid := ( for $a in $definedoc//odm:ItemDef[@Name='USUBJID']/@OID where $a = $definedoc//odm:ItemGroupDef[@Name=$datasetname]/odm:ItemRef/@ItemOID return $a ) (: get the EX or EC dataset :) let $ecexdataset := ( if($defineversion='2.1') then $definedoc//odm:ItemGroupDef[@Name=$datasetname][@Name='EX' or @Name='EC']/def21:leaf/@xlink:href else $definedoc//odm:ItemGroupDef[@Name=$datasetname][@Name='EX' or @Name='EC']/def:leaf/@xlink:href ) let $ecexdoc := doc(concat($base,$ecexdataset)) (: now iterate over all records in EX or EC that have a --STDTC :) for $record in $ecexdoc//odm:ItemGroupData[odm:ItemData[@ItemOID=$stdtcoid]] (: get the value of --STDTC :) let $stdtcvalue := $record/odm:ItemData[@ItemOID=$stdtcoid]/@Value (: get the value of USUBJID :) let $usubjidvalue := $record/odm:ItemData[@ItemOID=$usubjidoid]/@Value let $rfxstdtcvalue := $usubjidrfxstdtcpairs[@usubjid=$usubjidvalue]/@rfxstdtc let $recnum := $record/@data:ItemGroupDataSeq (: and compare with the value of RFXSTDTC in DM for the same USUBJID :) where $rfxstdtcvalue and xs:date($rfxstdtcvalue) > xs:date($stdtcvalue) (: and when the STDTC is before RFXSTDTC give an error :) return {data($stdtcname)} date '{data($stdtcvalue)}' is before RFXSTDTC '{data($rfxstdtcvalue)}' ]]> Start Date/Time of Treatment (EXSTDTC) variable value must be greater than or equal to Date/Time of Experimental Start Date (EXPSTDTC) in Trial Summary (TS) domain 3.0 3.1 EX Value of EXSTDTC={data($exstdtc)} is before TS.EXPSTDTC={data($expstdtc)} ]]> --TEST value must be consistent within --TESTCD All values of Name of Measurement, Test or Examination (--TEST) should be the same for a given value of Short Name of Measurement, Test or Examination (--TESTCD) 3.0 3.1 FINDINGS 1] (: start from the second one :) let $recnum := $record/@data:ItemGroupDataSeq (: get the value of --TEST :) let $testvalue := $record/odm:ItemData[@ItemOID=$testoid]/@Value (: take the previous record in the same group, and take its --TEST value :) let $precrecord := $record/preceding-sibling::odm:ItemGroupData[1] (: as they come in descending order :) let $recnum2 := $precrecord/@data:ItemGroupDataSeq let $testvalue2 := $precrecord/odm:ItemData[@ItemOID=$testoid]/@Value (: when the value of--TEST in both records is different, report an error :) where not($testvalue2 = $testvalue) return Inconsistent value for {data($testname)} within {data($testcdname)}='{data($testcdvalue)}' in dataset {data($datasetname)}. Following values were found: record number {data($recnum2)}: {data($testname)}={data($testvalue2)} - record number {data($recnum)}: {data($testname)}={data($testvalue)} ]]> --TEST value must be consistent within --TESTCD All values of Name of Measurement, Test or Examination (--TEST) should be the same for a given value of Short Name of Measurement, Test or Examination (--TESTCD) 3.0 3.1 FINDINGS 1] (: start from the second one :) let $recnum := $record/@data:ItemGroupDataSeq (: get the value of --TEST :) let $testvalue := $record/odm:ItemData[@ItemOID=$testoid]/@Value (: take the previous record in the same group, and take its --TEST value :) let $precrecord := $record/preceding-sibling::odm:ItemGroupData[1] (: as they come in descending order :) let $recnum2 := $precrecord/@data:ItemGroupDataSeq let $testvalue2 := $precrecord/odm:ItemData[@ItemOID=$testoid]/@Value (: when the value of--TEST in both records is different, report an error :) where not($testvalue2 = $testvalue) return Inconsistent value for {data($testname)} within {data($testcdname)}='{data($testcdvalue)}' in dataset {data($datasetname)}. Following values were found: record number {data($recnum2)}: {data($testname)}={data($testvalue2)} - record number {data($recnum)}: {data($testname)}={data($testvalue)} ]]> --TESTCD value must be consistent within --TEST All values of Short Name of Measurement, Test or Examination (--TESTCD) should be the same for a given value of Name of Measurement, Test or Examination (--TEST) 3.0 3.1 FINDINGS 1] (: start from the second one :) let $recnum := $record/@data:ItemGroupDataSeq let $testcdvalue := $record/odm:ItemData[@ItemOID=$testcdoid]/@Value (: take the previous record in the same group, and take its --TESTCD value :) let $precrecord := $record/preceding-sibling::odm:ItemGroupData[1] (: as they come in descending order :) let $recnum2 := $precrecord/@data:ItemGroupDataSeq let $testcdvalue2 := $precrecord/odm:ItemData[@ItemOID=$testcdoid]/@Value let $recnum2 := $precrecord/@data:ItemGroupDataSeq (: when the value of--TESTCD in both records is different, report an error :) where not($testcdvalue2 = $testcdvalue) return Inconsistent value for {data($testcdname)} within {data($testname)}='{data($testvalue)}' in dataset {data($datasetname)}. Following values were found: record number {data($recnum2)}: {data($testcdname)}={data($testcdvalue2)} - record number {data($recnum)}: {data($testcdname)}={data($testcdvalue)} ]]> --TESTCD value must be consistent within --TEST, single dataset or domain All values of Short Name of Measurement, Test or Examination (--TESTCD) should be the same for a given value of Name of Measurement, Test or Examination (--TEST) 3.0 3.1 FINDINGS 1] (: start from the second one :) let $recnum := $record/@data:ItemGroupDataSeq let $testcdvalue := $record/odm:ItemData[@ItemOID=$testcdoid]/@Value (: take the previous record in the same group, and take its --TESTCD value :) let $precrecord := $record/preceding-sibling::odm:ItemGroupData[1] (: as they come in descending order :) let $recnum2 := $precrecord/@data:ItemGroupDataSeq let $testcdvalue2 := $precrecord/odm:ItemData[@ItemOID=$testcdoid]/@Value let $recnum2 := $precrecord/@data:ItemGroupDataSeq (: when the value of--TESTCD in both records is different, report an error :) where not($testcdvalue2 = $testcdvalue) return Inconsistent value for {data($testcdname)} within {data($testname)}='{data($testvalue)}' in dataset {data($datasetname)}. Following values were found: record number {data($recnum2)}: {data($testcdname)}={data($testcdvalue2)} - record number {data($recnum)}: {data($testcdname)}={data($testcdvalue)} ]]> QLABEL value must be consistent within QNAM All values of Qualifier Variable Label (QLABEL) should be the same for a given value of Qualifier Variable Name (QNAM) 3.0 3.1 SUPPQUAL Inconsistent value for QLABEL within QNAM={data($uniqueqnam)} in dataset {data($datasetname)}. {data($uniqueqlabelvaluescount)} different combinations were found ]]> QNAM value must be consistent within QLABEL All values of Qualifier Variable Name (QNAM) should be the same for a given value of Qualifier Variable Label (QLABEL) 3.0 3.1 SUPPQUAL Inconsistent value for QNAM within QLABEL={data($uniqueqlabel)} in dataset {data($datasetname)}. {data($uniqueqnamvaluescount)} different combinations were found ]]> ARM value must be consistent A value for Description of Planned Arm (ARM) must have a unique value for Planned Arm Code (ARMCD) with the domain DM, TA, TV 3.0 3.1 DM TA TV Inconsistent value for ARM within ARMCD={data($uniquearmcd)} in dataset {data($datasetname)}. {data($uniquearmvaluescount)} different combinations were found ]]> ARMCD value must be consistent A value for Planned Arm Code (ARMCD) must have a unique value for Description of Planned Arm (ARM) with the domain within the domain DM, TA, TV 3.0 3.1 DM TA TV Inconsistent value for ARMCD within ARM={data($uniquearm)} in dataset {data($datasetname)}. {data($uniquearmcdvaluescount)} different combinations were found ]]> ELEMENT value may not be duplicate in TE The value of Element (Description of Element) variable must be unique within Trial Elements (TE) domain 3.0 3.1 TE $recnum] (: and compare the value of ELEMENT in the record with the original one :) let $recnum2 := $record2/@data:ItemGroupDataSeq let $elementvalue2 := $record2//odm:ItemData[@ItemOID=$elementoid]/@Value where $elementvalue=$elementvalue2 return Duplicate ELEMENT value: records {data($recnum)} and {data($recnum2)} have the same value for ELEMENT, value={data($elementvalue)} ]]> ETCD value may not be duplicate in TE The value of Element Code (ETCD) variable must be unique within Trial Elements (TE) domain 3.0 3.1 TE $recnum] (: and compare the value of ETCD in the record with the original one :) let $recnum2 := $record2/@data:ItemGroupDataSeq let $etcdvalue2 := $record2//odm:ItemData[@ItemOID=$etcdoid]/@Value where $etcdvalue=$etcdvalue2 return Duplicate ETCD value: records {data($recnum)} and {data($recnum2)} have the same value for ETCD, value={data($etcdvalue)} ]]> ETCD must be unique within ELEMENT Element Code (ETCD) must have a unique value for a given value of Description of Element (ELEMENT) within the domain 3.0 3.1 SE TA 1] let $etcdvalue2 := $record/odm:ItemData[@ItemOID=$etcdoid]/@Value (: if the ETCD value is different from that within the first record of the group, give an error :) let $recnum2 := $record/@data:ItemGroupDataSeq where $etcdvalue != $etcdvalue2 return Non-unique value for ETCD within ELEMENT '{data($elementvalue)}' in dataset {data($datasetname)}. Record {data($recnum2)} has ETCD value '{data($etcdvalue2)}' whereas record {data($recnum)} has ETCD value '{data($etcdvalue)}' ]]> TA dataset must be present Trial Arms (TA) dataset must be included in every submission 3.0 3.1 TA Document {data($tadatasetname)} could not be found in collection {data($base)} ]]> TE dataset must be present Trial Elements (TE) dataset should be included in every submission 3.0 3.1 TE Document {data($tedatasetname)} could not be found in collection {data($base)} ]]> TX dataset must be present Trial Sets (TX) dataset must be included in every submission 3.0 3.1 TX Document TX could not be found in collection {data($base)} ]]> 'Age Unit' (AGEU) record must be populated in Trial Summary (TS) 3.0 3.1 TS No TSPARMCD=AGEU record found is TS ]]> 'Study Design' (SDESIGN) record must be populated in Trial Summary (TS) domain 3.0 3.1 TS No TSPARMCD=SDESIGN record found is TS ]]> 'Study Design' (SDESIGN) record must be populated in Trial Summary (TS) domain 3.0 3.1 TS No TSPARMCD=SDESIGN record found is TS ]]> 'Experimental End Date' (EXPENDTC) record must be populated in Trial Summary (TS) domain 3.0 3.1 TS No TSPARMCD=EXPENDTC record found is TS ]]> 'Experimental Start Date' (EXPSTDTC) record must be populated in Trial Summary (TS) domain 3.0 3.1 TS No TSPARMCD=EXPSTDTC record found is TS ]]> 'Good Laboratory Practice Type' (GLPTYP) record must be populated in Trial Summary (TS) domain 3.0 3.1 TS No TSPARMCD=GLPTYP record found is TS ]]> 'Route of Administration' (ROUTE) record must be populated in Trial Summary (TS) domain 3.0 3.1 TS No TSPARMCD=ROUTE record found is TS ]]> 'SEND Implementation Guide Version' (SNDIGVER) record must be populated in Trial Summary (TS) domain 3.0 3.1 TS No TSPARMCD=SNDIGVER record found is TS ]]> 'SEND Control Terminology Version' (SNDCTVER) record must be populated in Trial Summary (TS) domain 3.0 3.1 TS No TSPARMCD=SNDCTVER record found is TS ]]> 'Species' (SPECIES) record should be populated in Trial Summary (TS) domain record must be populated in Trial Summary (TS) domain 3.0 3.1 TS No TSPARMCD=SPECIES record found is TS ]]> 'Test Subject Supplier' (SPLRNAM) record should be populated in Trial Summary (TS) domain record must be populated in Trial Summary (TS) domain 3.0 3.1 TS No TSPARMCD=SPLRNAM record found is TS ]]> 'Sponsor's Reference ID' (SPREFID) record should be populated in Trial Summary (TS) domain record must be populated in Trial Summary (TS) domain 3.0 3.1 TS No TSPARMCD=SPREFID record found is TS ]]> 'Sponsoring Organization' (SSPONSOR) record should be populated in Trial Summary (TS) domain record must be populated in Trial Summary (TS) domain 3.0 3.1 TS No TSPARMCD=SSPONSOR record found is TS ]]> 'Study Category' (STCAT) record should be populated in Trial Summary (TS) domain record must be populated in Trial Summary (TS) domain 3.0 3.1 TS No TSPARMCD=STCAT record found is TS ]]> 'Study Director' (STDIR) record should be populated in Trial Summary (TS) domain record must be populated in Trial Summary (TS) domain 3.0 3.1 TS No TSPARMCD=STDIR record found is TS ]]> 'Strain/Substrain' (STRAIN) record should be populated in Trial Summary (TS) domain record must be populated in Trial Summary (TS) domain 3.0 3.1 TS No TSPARMCD=STRAIN record found is TS ]]> 'Study Start Date' (STSTDTC) record should be populated in Trial Summary (TS) domain record must be populated in Trial Summary (TS) domain 3.0 3.1 TS No TSPARMCD=STSTDTC record found is TS ]]> 'Study Title' (STITLE) record should be populated in Trial Summary (TS) domain record must be populated in Trial Summary (TS) domain 3.0 3.1 TS No TSPARMCD=STITLE record found is TS ]]> 'Study Type' (SSTYP) record should be populated in Trial Summary (TS) domain record must be populated in Trial Summary (TS) domain 3.0 3.1 TS No TSPARMCD=SSTYP record found is TS ]]> 'Investigational Therapy or Treatment' (TRT) record should be populated in Trial Summary (TS) domain record must be populated in Trial Summary (TS) domain 3.0 3.1 TS No TSPARMCD=TRT record found is TS ]]> 'Test Facility Country' (TFCNTRY) record should be populated in Trial Summary (TS) domain record must be populated in Trial Summary (TS) domain 3.0 3.1 TS No TSPARMCD=TFCNTRY record found is TS ]]> 'Test Facility Location' (TSTFLOC) record should be populated in Trial Summary (TS) domain record must be populated in Trial Summary (TS) domain 3.0 3.1 TS No TSPARMCD=TSTFLOC record found is TS ]]> 'Test Facility Name' (TSTFNAM) record should be populated in Trial Summary (TS) domain record must be populated in Trial Summary (TS) domain 3.0 3.1 TS No TSPARMCD=TSTFNAM record found is TS ]]> 'Time to Terminal Sacrifice' (TRMSAC) record should be populated in Trial Summary (TS) domain record must be populated in Trial Summary (TS) domain 3.0 3.1 TS No TSPARMCD=TRMSAC record found is TS ]]> 'Primary Treatment CAS Registry Number' (TRTCAS) record should be populated in Trial Summary (TS) domain record must be populated in Trial Summary (TS) domain 3.0 3.1 TS No TSPARMCD=TRTCAS record found is TS ]]> 'Treatment Vehicle' (TRTV) record should be populated in Trial Summary (TS) domain record must be populated in Trial Summary (TS) domain 3.0 3.1 TS No TSPARMCD=TRTV record found is TS ]]> --VAMTU must be populated, when --VAMT is populated Treatment Vehicle Amount Units (--VAMTU) should not be NULL, when Treatment Vehicle Amount (--VAMT) is populated 3.0 3.1 INTERVENTIONS Missing value for {data($vamtuname)}, when {data($vamtname)} is populated ]]> Every subject must have a baseline result All subjects should have at least one baseline observation (--BLFL = 'Y') in EG, LB, MB, MS, PC and VS domains, except for subjects who failed screening (ARMCD = 'SCRNFAIL') or were not fully assigned to an Arm (ARMCD = 'NOTASSGN') or were not treated (ACTARMCD = 'NOTTRT') 3.0 3.1 EG LB MB MS PC VS {data($domain)} - {data($blfloid)} :) (: iterate over all the randomized subjects and count the number of baseline flag records over all the datasets within that domain :) for $subject in $randomizedsubjects let $count := count( for $dataset in $datasetslocationsindomain let $c := doc($dataset)//odm:ItemGroupData[odm:ItemData[@ItemOID=$usubjidoid][@Value=$subject] and odm:ItemData[@ItemOID=$blfloid]]/@data:ItemGroupDataSeq return $c ) (: $count gives the number of records with a baseline flag for the subject :) where count($datasets) > 0 and $count = 0 (: no baseline record for this subject found in any of the datasets in this domain :) return No baseline result in Domain {data($domain)} for subject {data($subject)} ]]> Every subject must have a baseline result All subjects should have at least one baseline observation (--BLFL = 'Y') in EG, LB, MB, MS, PC and VS domains, except for subjects who failed screening (ARMCD = 'SCRNFAIL') or were not fully assigned to an Arm (ARMCD = 'NOTASSGN') or were not treated (ACTARMCD = 'NOTTRT') 3.1.2 3.1.3 3.2 EG LB MB MS PC VS {data($domain)} - {data($blfloid)} :) (: iterate over all the randomized subjects and count the number of baseline flag records over all the datasets within that domain :) for $subject in $randomizedsubjects (: $randomizedsubjects is a list of randomized subjects :) (: $count gives the number of records with a baseline flag for the subject :) let $count := count($datasetdoc//odm:ItemGroupData[odm:ItemData[@ItemOID=$usubjidoid and @Value=$subject] and odm:ItemData[@ItemOID=$blfloid and @Value='Y']]) where $count = 0 (: no baseline record for this subject found in any of the datasets in this domain :) return No baseline result in Dataset {data($domain)} for subject {data($subject)} ]]> --BLFL variable must be present in every custom Findings domain Baseline Flag (--BLFL) should be present in all custom Findings domains 3.0 3.1 FINDINGS No baseline variable {data($blflname)} in custom Findings dataset {data(name)} ]]> Character values may not have leading spaces Character values should not have leading space ' ' characters, or '.' as an entire value. The only exceptions are COVALn and TSVALn variables 3.0 3.1 ALL {data($charvaroids)} :) (: iterate over all data points that are not of type 'integer' or 'float' :) for $record in $datasetdoc//odm:ItemGroupData (: get the record number :) let $recnum := $record/@data:ItemGroupDataSeq for $datapoint in $record/odm:ItemData[functx:is-value-in-sequence(@ItemOID,$charvaroids)] (: get the name from the OID :) let $varname := $definedoc//odm:ItemDef[@OID=$datapoint/@ItemOID]/@Name (: get the value :) let $value := $datapoint/@Value (: when the first character is a space, or the whole value is '.' give an warning :) where $value = '.' or starts-with($value,' ') return Unexpected character value in non-numeric variable value {data($varname)}. Value '{data($value)}' was found ]]> --DY variable must be present, when --DTC variable is present Collection Study Day (--DY) variable should be included into dataset, when Collection Study Date/Time (--DTC) variable is present 3.0 3.1 ALL Collection Study Day {data(concat($name,'DY'))} variable must be included into dataset, when Collection Study Date/Time {data($dtcname)} variable is present in dataset {data($datasetname)} ]]> DM dataset must be included Demographics (DM) dataset must be included in every submission 3.0 3.1 DM Document {data($dmdatasetname)} could not be found in collection {data($base)} ]]> TS dataset must be included Trial Summary (TS) dataset must be included in every submission 3.0 3.1 TS Document {data($tsdatasetname)} could not be found in collection {data($base)} ]]> Dataset may not be greater than 5 GB in size Large datasets should be split into smaller datasets no larger than 5 GB in size. 3.0 3.1 ALL (5*1024) return Size of file {$child} is larger than 1GB - file size found = {$size} MB ]]> Dataset may not be greater than 5 GB in size Large datasets should be split into smaller datasets no larger than 5 GB in size. 3.0 3.1 ALL 5*1024 return Size of file {data($datasetloc)} is larger than 5GB - file size found = {$filesize} MB ]]> --STRESC value must be present for Baseline record A Standard Result value (--STRESC) is expected to be populated for Baseline records (--BLFL="Y") 3.0 3.1 FINDINGS Missing {data($strescname)}, when {data($blflname)} value={data($blflvalue)} is provided in dataset {data($datasetname)} ]]> --STRESC value must be present for Baseline record A Standard Result value (--STRESC) is expected to be populated for Baseline records (--BLFL="Y") 3.0 3.1 FINDINGS Missing {data($strescname)}, when {data($blflname)} value={data($blflvalue)} is provided in dataset {data($datasetname)} ]]> Variables described in SEND IG as Required must be included in the dataset 3.0 3.1 ALL , $cdisclibraryquerysdtmig) (: make an inventory of the variables that are required using the web service for this domain and SDS version :) let $requiredvars := $cdisclibrarysdtmigresponse/json/datasets/*[name=$domain]/datasetVariables/*[core='Req']/name/text() (: iterate over the required variables for this dataset, and then check whether the variable is present :) let $datasetpath := concat($base,$dataset) let $datasetdoc := doc($datasetpath) (: Iterate over the required variables :) for $requiredvar in $requiredvars (: get the OID, if defined for this dataset :) let $requiredoid := ( for $a in $itemgroup/odm:ItemRef/@ItemOID where $requiredvar = $definedoc//odm:ItemDef[@OID=$a]/@Name return $a ) (: Required variable is not defined for this dataset :) where not($requiredoid) return SENDIG Required variable '{data($requiredvar)}' is not present in dataset '{data($dsname)}' ]]> Variables described in SEND IG as Expected must be included in the dataset 3.0 3.1 ALL , $cdisclibraryquerysdtmig) (: make an inventory of the variables that are required using the web service for this domain and SDS version :) let $expectedvars := $cdisclibrarysdtmigresponse/json/datasets/*[name=$domain]/datasetVariables/*[core='Exp']/name/text() (: iterate over the expected variables for this dataset, and then check whether the variable is present :) let $datasetpath := concat($base,$dataset) let $datasetdoc := doc($datasetpath) (: Iterate over the expected variables :) for $expectedvar in $expectedvars (: get the OID, if defined for this dataset :) let $expectedvaroid := ( for $a in $itemgroup/odm:ItemRef/@ItemOID where $expectedvar = $definedoc//odm:ItemDef[@OID=$a]/@Name return $a ) (: Expected variable is not defined for this dataset :) where not($expectedvaroid) return SENDIG Expected variable '{data($expectedvar)}' is not present in dataset '{data($dsname)}' ]]> --STRESC must be populated, when --STAT is null Character Result/Finding in Std Format (--STRESC) value should not be NULL, when Status Flag (--STAT) value is null 3.0 3.1 FINDINGS Missing value for {data($strescname)}, when {data($statname)}=null ]]> --STRESN must be populated when standardized value is numeric Standardized Result in Numeric Format (--STRESN) variable value should be populated, when Standardized Result in Character Format (--STRESC) variable value represents a numeric value 3.0 3.1 FINDINGS Missing value for {data($stresnname)}, when {data($strescname)} value={data($strescvalue)} is provided and represents a numeric value in dataset {data($datasetname)} ]]> --STRESN must be populated when standardized value is numeric Standardized Result in Numeric Format (--STRESN) variable value should be populated, when Standardized Result in Character Format (--STRESC) variable value represents a numeric value 3.0 3.1 FINDINGS Missing value for {data($stresnname)}, when {data($strescname)} value={data($strescvalue)} is provided and represents a numeric value in dataset {data($datasetname)} ]]> --STRESN must be equal to --STRESC Standardized Result in Numeric Format (--STRESN) variable value should be populated, when Standardized Result in Character Format (--STRESC) variable value represents a numeric value 3.0 3.1 FINDINGS Value for {data($stresnname)} '{data($stresnvalue)}' does not equal value for {data($strescname)} '{data($strescvalue)}' ]]> --STRESN must be equal to --STRESC Standardized Result in Numeric Format (--STRESN) variable value should be populated, when Standardized Result in Character Format (--STRESC) variable value represents a numeric value 3.0 3.1 FINDINGS Value for {data($stresnname)} '{data($stresnvalue)}' does not equal value for {data($strescname)} '{data($strescvalue)}' ]]> --DTC or --DY must be populated Start Date/Time of Observation (--DTC) or Study Day of Observation (--DY) should be populated in the Findings observation class where data are usually collected at multiple study days. 3.0 3.1 FINDINGS Missing values for both {data($dtcname)} and {data($dyname)} variables ]]> --DTC or --DY must be populated Start Date/Time of Observation (--DTC) or Study Day of Observation (--DY) should be populated in the Findings observation class where data are usually collected at multiple study days. 3.0 3.1 FINDINGS Missing values for both {data($dtcname)} and {data($dyname)} variables ]]> Exposure end date may not be after the latest Disposition date End Date/Time of Treatment (EXENDTC) should be less than or equal to the Start Date/Time of the latest Disposition Event (DSSTDTC) 3.0 3.1 EX DS Exposure end date EXENDTC={data($exendtcvalue)} for USUBJID={data($exusubjidvalue)} is after last disposition date {data($latestdate)} ]]> --STDY may not be after --ENDY Study Day of Start of Event, Exposure or Observation (--STDY) must be less or equal to Study Day of End of Event, Exposure or Observation (--ENDY) 3.0 3.1 INTERVENTIONS EVENTS FINDINGS number($endyvalue) return {data($stdyname)}={data($stdyvalue)} is after {data($endyname)}={data($endyvalue)} ]]> --STDY may not be after --ENDY Study Day of Start of Event, Exposure or Observation (--STDY) must be less or equal to Study Day of End of Event, Exposure or Observation (--ENDY) 3.0 3.1 INTERVENTIONS EVENTS FINDINGS number($endyvalue) return {data($stdyname)}={data($stdyvalue)} is after {data($endyname)}={data($endyvalue)} ]]> 3.0 3.1 --STDTC may not be after --ENDTC Start Date/Time of Event, Exposure or Observation (--STDTC) must be less or equal to End Date/Time of Event, Exposure or Observation (--ENDTC) ALL xs:dateTime($endtctestvalue) return {data($stdtcname)}={data($stdtcvalue)} is after {data($endtcname)}={data($endtcvalue)} in dataset {data($datasetname)} ]]> 3.0 3.1 --STDTC may not be after --ENDTC Start Date/Time of Event, Exposure or Observation (--STDTC) must be less or equal to End Date/Time of Event, Exposure or Observation (--ENDTC) ALL xs:dateTime($endtctestvalue) return {data($stdtcname)}={data($stdtcvalue)} is after {data($endtcname)}={data($endtcvalue)} in dataset {data($datasetname)} ]]> --DTC may not be after --ENDTC Date/Time of Specimen Collection (--DTC) must be less or equal to End Date/Time of Specimen Collection (--ENDTC) 3.0 3.1 FINDINGS xs:dateTime($endtctestvalue) return {data($dtcname)}={data($dtcvalue)} is after {data($endtcname)}={data($endtcvalue)} in dataset {data($name)} ]]> --DTC may not be after --ENDTC Date/Time of Specimen Collection (--DTC) must be less or equal to End Date/Time of Specimen Collection (--ENDTC) 3.0 3.1 FINDINGS xs:dateTime($endtctestvalue) return {data($dtcname)}={data($dtcvalue)} is after {data($endtcname)}={data($endtcvalue)} in dataset {data($name)} ]]> RFSTDTC may not be after RFENDTC Subject Reference Start Date/Time (RFSTDTC) must be less than or equal to Subject Reference End Date/Time (RFENDTC) 3.0 3.1 DM xs:dateTime($endtctestvalue) return RFSTDTC={data($rfstdtcvalue)} is after RFENDTC={data($rfendtcvalue)} for subject with USUBJID={data($usubjidvalue)} ]]> --STDY variable must be present, when --STDTC variable is present Study Day of Start (--STDY) variable should be included into dataset, when Start Study Date/Time (--STDTC) variable is present 3.0 3.1 INTERVENTIONS EVENTS FINDINGS SV SE Missing {data($stdyname)} variable in dataset {data($datasetname)}, when {data($stdtcname)} variable is present ]]> --ENDY variable must be present, when --ENDTC variable is present Study Day of End (--ENDY) variable should be included into dataset, when End Study Date/Time (--ENDTC) variable is present 3.0 3.1 INTERVENTIONS EVENTS FINDINGS SV SE Missing {data($endyname)} variable in dataset {data($datasetname)}, when {data($endtcname)} variable is present ]]> EXSTDTC date may not be after RFXENDTC Start Date/Time of Treatment (EXSTDTC) variable value must be less than or equal to Date/Time of Last Study Treatment (RFXENDTC) 3.1 EX ) (: iterate over all EX datasets :) for $datasetdef in $definedoc//odm:ItemGroupDef[@Domain='EX' or starts-with(@Name,'EX')] (: get the dataset name :) let $name := $datasetdef/@Name let $domain := $datasetdef/@Domain (: get the datasetlocation :) let $datasetlocation := ( if($defineversion='2.1') then $datasetdef/def21:leaf/@xlink:href else $datasetdef/def:leaf/@xlink:href ) (: we need the OID of USUBJID and of the EXSTDTC variable :) let $exstdtcoid := ( for $a in $definedoc//odm:ItemDef[@Name='EXSTDTC']/@OID where $a = $datasetdef/odm:ItemRef/@ItemOID return $a ) let $usubjidoid := ( for $a in $definedoc//odm:ItemDef[@Name='USUBJID']/@OID where $a = $datasetdef/odm:ItemRef/@ItemOID return $a ) (: now iterate over all records that do have a value for --EXSTDTC :) for $record in doc(concat($base,$datasetlocation))//odm:ItemGroupData[odm:ItemData[@ItemOID=$exstdtcoid]/@Value] let $recnum := $record/@data:ItemGroupDataSeq (: get the value of --ENDTC and of USUBJID :) let $usubjidvalue := $record/odm:ItemData[@ItemOID=$usubjidoid]/@Value let $exstdtcvalue := $record/odm:ItemData[@ItemOID=$exstdtcoid]/@Value (: get the value of RFPENDTC in DM from the temporary structure :) let $rfxendtcvalue := $usubjidrfxendtcpairs[@usubjid=$usubjidvalue]/@rfpendtc (: take care of incomplete dates :) let $exstdtctestvalue := (: only the year is given :) if(string-length($exstdtcvalue) = 4) then concat($exstdtcvalue,'-01-01T00:00:00') (: only the month is given :) else if(string-length($exstdtcvalue) = 7) then concat($exstdtcvalue,'-01T00:00:00') (: complete date is given but no time :) else if(string-length($exstdtcvalue) = 10) then concat($exstdtcvalue,'T00:00:00') (: T is given but no hours - might bei invalid anyway :) else if(string-length($exstdtcvalue) = 11) then concat($exstdtcvalue,'00:00:00') (: only hour is given :) else if(string-length($exstdtcvalue) = 13) then concat($exstdtcvalue,':00:00') (: hour and minutes are given, but no seconds :) else if(string-length($exstdtcvalue) = 16) then concat($exstdtcvalue,':00') (: all ok anyway :) else ($exstdtcvalue) (: and also for RFXENDTC :) let $rfxendtctestvalue := ( (: only the year is given :) if(string-length($rfxendtcvalue) = 4) then concat($rfxendtcvalue,'-01-01T00:00:00') (: only the month is given :) else if(string-length($rfxendtcvalue) = 7) then concat($rfxendtcvalue,'-01T00:00:00') (: complete date is given but no time :) else if(string-length($rfxendtcvalue) = 10) then concat($rfxendtcvalue,'T00:00:00') (: T is given but no hours - might bei invalid anyway :) else if(string-length($rfxendtcvalue) = 11) then concat($rfxendtcvalue,'00:00:00') (: only hour is given :) else if(string-length($rfxendtcvalue) = 13) then concat($rfxendtcvalue,':00:00') (: hour and minutes are given, but no seconds :) else if(string-length($rfxendtcvalue) = 16) then concat($rfxendtcvalue,':00') (: all ok anyway :) else ($rfxendtcvalue) ) (: compare both values :) (: RFXENDTC value must be equal or higher than EXSTDTC - but first check whether it really is a datetime :) where $exstdtctestvalue castable as xs:dateTime and $rfxendtctestvalue castable as xs:dateTime and xs:dateTime($exstdtctestvalue) > xs:dateTime($rfxendtctestvalue) return EXSTDTC={data($exstdtcvalue)} is after RFXENDTC={data($rfxendtcvalue)} in dataset {data($name)} ]]> EXENDTC date may not be after RFXENDTC End Date/Time of Treatment (EXENDTC) variable value must be less than or equal to Date/Time of Last Study Treatment (RFXENDTC) 3.1 EX ) (: iterate over all EX datasets :) for $datasetdef in $definedoc//odm:ItemGroupDef[@Domain='EX' or starts-with(@Name,'EX')] (: get the dataset name :) let $name := $datasetdef/@Name let $domain := $datasetdef/@Domain (: get the datasetlocation :) let $datasetlocation := ( if($defineversion='2.1') then $datasetdef/def21:leaf/@xlink:href else $datasetdef/def:leaf/@xlink:href ) let $datasetdoc := ( if($datasetlocation) then doc(concat($base,$datasetlocation)) else () ) (: we need the OID of USUBJID and of the EXENDTC variable :) let $exendtcoid := ( for $a in $definedoc//odm:ItemDef[@Name='EXENDTC']/@OID where $a = $datasetdef/odm:ItemRef/@ItemOID return $a ) let $usubjidoid := ( for $a in $definedoc//odm:ItemDef[@Name='USUBJID']/@OID where $a = $datasetdef/odm:ItemRef/@ItemOID return $a ) (: now iterate over all records that do have a value for --EXSTDTC :) for $record in $datasetdoc//odm:ItemGroupData[odm:ItemData[@ItemOID=$exendtcoid]/@Value] let $recnum := $record/@data:ItemGroupDataSeq (: get the value of --ENDTC and of USUBJID :) let $usubjidvalue := $record/odm:ItemData[@ItemOID=$usubjidoid]/@Value let $exendtcvalue := $record/odm:ItemData[@ItemOID=$exendtcoid]/@Value (: get the value of RFPENDTC in DM from the temporary structure :) let $rfxendtcvalue := $usubjidrfxendtcpairs[@usubjid=$usubjidvalue]/@rfpendtc (: take care of incomplete dates :) let $exendtctestvalue := (: only the year is given :) if(string-length($exendtcvalue) = 4) then concat($exendtcvalue,'-01-01T00:00:00') (: only the month is given :) else if(string-length($exendtcvalue) = 7) then concat($exendtcvalue,'-01T00:00:00') (: complete date is given but no time :) else if(string-length($exendtcvalue) = 10) then concat($exendtcvalue,'T00:00:00') (: T is given but no hours - might bei invalid anyway :) else if(string-length($exendtcvalue) = 11) then concat($exendtcvalue,'00:00:00') (: only hour is given :) else if(string-length($exendtcvalue) = 13) then concat($exendtcvalue,':00:00') (: hour and minutes are given, but no seconds :) else if(string-length($exendtcvalue) = 16) then concat($exendtcvalue,':00') (: all ok anyway :) else ($exendtcvalue) (: and also for RFXENDTC :) let $rfxendtctestvalue := ( (: only the year is given :) if(string-length($rfxendtcvalue) = 4) then concat($rfxendtcvalue,'-01-01T00:00:00') (: only the month is given :) else if(string-length($rfxendtcvalue) = 7) then concat($rfxendtcvalue,'-01T00:00:00') (: complete date is given but no time :) else if(string-length($rfxendtcvalue) = 10) then concat($rfxendtcvalue,'T00:00:00') (: T is given but no hours - might bei invalid anyway :) else if(string-length($rfxendtcvalue) = 11) then concat($rfxendtcvalue,'00:00:00') (: only hour is given :) else if(string-length($rfxendtcvalue) = 13) then concat($rfxendtcvalue,':00:00') (: hour and minutes are given, but no seconds :) else if(string-length($rfxendtcvalue) = 16) then concat($rfxendtcvalue,':00') (: all ok anyway :) else ($rfxendtcvalue) ) (: compare both values :) (: RFXENDTC value must be equal or higher than EXENDTC - but first check whether it really is a datetime :) where $exendtctestvalue castable as xs:dateTime and $rfxendtctestvalue castable as xs:dateTime and xs:dateTime($exendtctestvalue) > xs:dateTime($rfxendtctestvalue) return EXENDTC={data($exendtcvalue)} is after RFXENDTC={data($rfxendtcvalue)} in dataset {data($name)} ]]> RFXSTDTC date may not be after RFXENDTC Date/Time of First Study Treatment (RFXSTDTC) variable value must be less than or equal to Date/Time of Last Study Treatment (RFXENDTC) 3.1 DM xs:dateTime($rfxendtctestvalue) return RFXSTDTC={data($rfxstdtcvalue)} is after RFXENDTC={data($rfxendtcvalue)} in dataset DM ]]> Dataset must be defined in the define.xml Datasets included in study data must be described in the data definition document (define.xml) 3.0 3.1 ALL Dataset {data($filename)} is not present in define file {data($define)} ]]> Domain referenced in define.xml must be included in the submission Domains referenced in data definition document (define.xml) should be included in the submission 3.0 3.1 ALL Dataset {data($filename)} referenced in {$define} but dataset is missing in submission ]]> Variables defined in the define.xml must be present in the dataset Variables listed in the data definition document (define.xml) should be included in the dataset 3.0 3.1 ALL Variable {data($varname)} in dataset {data($datasetname)} is defined in the define.xml but cannot be found in the dataset {data($datasetname)} ]]> Variables included in the dataset must be defined in the define.xml Variables included in the dataset must be described in the data definition document (define.xml) 3.0 3.1 ALL Variable with OID {data($var)} in dataset {data($datasetname)} in the dataset {data($datasetname)} is not defined in the define.xml ]]> Variable datatype must match datatype in the define.xml Variable Data Types in the dataset must match the variable data types described in the data definition document (define.xml) 3.0 3.1 ALL Define.xml/dataset variable type mismatch - Data point with OID = {data($itemoid)} and name = {data($varname)} and value {data($itemvalue)} is expected to be of type {data($datatype)} ]]> Variable values must be found in the corresponding user-defined codelist Variable values should be populated with terms found in the user-defined codelist associated with the variable in define.xml 3.0 3.1 ALL 0]//odm:ItemGroupData let $recnum := $record/@data:ItemGroupDataSeq (: iterate over the coded variables :) for $codeditem in $record/odm:ItemData[functx:is-value-in-sequence(@ItemOID,$codedoids)] (: get the OID and value :) let $oid := $codeditem/@ItemOID let $value := $codeditem/@Value (: also get the variable name for reporting :) let $varname := $definedoc//odm:ItemDef[@OID=$oid]/@Name (: look up the allowed values for this coded item in the define.xml :) let $codelistoid := $definedoc//odm:ItemDef[@OID=$oid]/odm:CodeListRef/@CodeListOID (: P.S. exclude "ExternalCodeList" :) let $allowedvalues := $definedoc//odm:CodeList[not(odm:ExternalCodeList)][@OID=$codelistoid]/odm:*/@CodedValue (: the value must be one of the coded values :) where count($allowedvalues) > 0 and not(functx:is-value-in-sequence($value,$allowedvalues)) return Value for variable {data($varname)}: value '{data($value)}' not found in not found in user-defined codelist {data($codelistoid)} ]]> Variable values must be found in the corresponding user-defined codelist Variable values should be populated with terms found in the user-defined codelist associated with the variable in define.xml 3.0 3.1 ALL 0]//odm:ItemGroupData let $recnum := $record/@data:ItemGroupDataSeq (: iterate over the coded variables :) for $codeditem in $record/odm:ItemData[functx:is-value-in-sequence(@ItemOID,$codedoids)] (: get the OID and value :) let $oid := $codeditem/@ItemOID let $value := $codeditem/@Value (: also get the variable name for reporting :) let $varname := $definedoc//odm:ItemDef[@OID=$oid]/@Name (: look up the allowed values for this coded item in the define.xml :) let $codelistoid := $definedoc//odm:ItemDef[@OID=$oid]/odm:CodeListRef/@CodeListOID (: P.S. exclude "ExternalCodeList" :) let $allowedvalues := $definedoc//odm:CodeList[not(odm:ExternalCodeList)][@OID=$codelistoid]/odm:*/@CodedValue (: the value must be one of the coded values :) where count($allowedvalues) > 0 and not(functx:is-value-in-sequence($value,$allowedvalues)) return Value for variable {data($varname)}: value '{data($value)}' not found in not found in user-defined codelist {data($codelistoid)} ]]> Variable value must be found in user-defined codelist when value-level condition occurs Variable value must be populated with terms from user-defined value level codelist as specified in define.xml file 3.0 3.1 ALL {data($valuelistvars)} :) (: iterate over the variables (OIDs) that do have an attached ValueList :) for $valuelistvar in $valuelistvars (: get the Name of the variable :) let $valuelistvarname := $definedoc//odm:ItemDef[@OID=$valuelistvar]/@Name (: get the reference valuelist itself :) let $valuelistoid := $definedoc//odm:ItemDef[@OID=$valuelistvar]/def:ValueListRef/@ValueListOID let $valuelist := $definedoc//def:ValueListDef[@OID=$valuelistoid] (: iterate over the ValueList ItemRefs :) for $valuelistitemref in $valuelist/odm:ItemRef (: get the OID :) let $valuelistitemoid := $valuelistitemref/@ItemOID (: get the WhereClause :) let $whereclauserefoid := $valuelistitemref/def:WhereClauseRef/@WhereClauseOID (: and the corresponding WhereClauseDef :) let $whereclausedef := $definedoc//def:WhereClauseDef[@OID=$whereclauserefoid] (: get the item it is about - we currently only support 1 item and only the "EQ" comparator, and only the case that it is about data in the same dataset (e.g. STRESU depends of TESTCD value) This covers 90% of the cases :) let $whereclauseaboutitemoid := $whereclausedef/odm:RangeCheck/@def:ItemOID let $checkvalue := $whereclausedef/odm:RangeCheck/odm:CheckValue/text() (: return {data($whereclauseaboutitemoid)} - {data($checkvalue)} :) (: pick up the corresponding ItemDef - but only when it does have a connected codelist :) for $valuelistitemdefcoded in $definedoc//odm:ItemDef[@OID=$valuelistitemoid and odm:CodeListRef/@CodeListOID] (: get the codelist itself and its coded values :) let $valuelistcodelistoid := $valuelistitemdefcoded/odm:CodeListRef/@CodeListOID (: exclude ExternalCodeList :) let $valuelistcodelist := $definedoc//odm:CodeList[@OID=$valuelistcodelistoid and not(odm:ExternalCodeList)] let $valuelistcodelistname := $valuelistcodelist/@Name (: get the coded values :) let $valuelistcodedvalues := $valuelistcodelist/odm:*/@CodedValue (: get all the records in the dataset that are about the given valuelist variable :) (: return {data($valuelistvar)} - {data($whereclauseaboutitemoid)} - {data($checkvalue)} - {data($valuelistcodedvalues)} :) (: iterate over all the records where the WhereClause applies to, i.e. $whereclauseaboutitemoid = $checkvalue :) for $record in $datasetdoc//odm:ItemGroupData[odm:ItemData[@ItemOID=$whereclauseaboutitemoid and @Value=$checkvalue]] let $recnum := $record/@data:ItemGroupDataSeq (: get the value of the dependent variable :) let $dependentvarvalue := $record/odm:ItemData[@ItemOID=$valuelistvar]/@Value (: the dependent variable value must be a value in the codelist :) where not(functx:is-value-in-sequence($dependentvarvalue,$valuelistcodedvalues)) return Variable {data($valuelistvarname)} valuelist value '{data($dependentvarvalue)}' is not found in user-defined codelist '{data($valuelistcodelistname)}'. One of [{data($valuelistcodedvalues)}] is expected ]]> Variable value may not be null when value-level mandatory condition occurs Variable value must be populated when value level attribute Mandatory='Yes' as specified in define.xml file 3.0 3.1 ALL {data($valuelistvars)} :) (: iterate over the variables (OIDs) that do have an attached ValueList :) for $valuelistvar in $valuelistvars (: get the Name of the variable :) let $valuelistvarname := $definedoc//odm:ItemDef[@OID=$valuelistvar]/@Name (: get the reference valuelist itself :) let $valuelistoid := $definedoc//odm:ItemDef[@OID=$valuelistvar]/def:ValueListRef/@ValueListOID let $valuelist := $definedoc//def:ValueListDef[@OID=$valuelistoid] (: iterate over the ValueList ItemRefs that are "Mandatory" :) for $valuelistitemref in $valuelist/odm:ItemRef[@Mandatory='Yes'] (: get the OID :) let $valuelistitemoid := $valuelistitemref/@ItemOID (: get the WhereClause :) let $whereclauserefoid := $valuelistitemref/def:WhereClauseRef/@WhereClauseOID (: and the corresponding WhereClauseDef :) let $whereclausedef := $definedoc//def:WhereClauseDef[@OID=$whereclauserefoid] (: get the item it is about - we currently only support 1 item and only the "EQ" comparator, and only the case that it is about data in the same dataset (e.g. STRESU depends of TESTCD value) This covers 90% of the cases :) let $whereclauseaboutitemoid := $whereclausedef/odm:RangeCheck/@def:ItemOID let $whereclauseaboutitemname := $definedoc//odm:ItemDef[@OID=$whereclauseaboutitemoid]/@Name let $checkvalue := $whereclausedef/odm:RangeCheck/odm:CheckValue/text() (: return {data($whereclauseaboutitemoid)} - {data($checkvalue)} :) (: pick up the corresponding ItemDef :) for $valuelistitemdefmandatory in $definedoc//odm:ItemDef[@OID=$valuelistitemoid] (: get all the records in the dataset that are about the given valuelist variable :) (: return {data($valuelistvar)} - {data($whereclauseaboutitemoid)} - {data($checkvalue)} - {data($valuelistcodedvalues)} :) (: iterate over all the records where the WhereClause applies to, i.e. $whereclauseaboutitemoid = $checkvalue :) for $record in $datasetdoc//odm:ItemGroupData[odm:ItemData[@ItemOID=$whereclauseaboutitemoid and @Value=$checkvalue]] let $recnum := $record/@data:ItemGroupDataSeq (: get the value of the dependent variable :) let $dependentvarvalue := $record/odm:ItemData[@ItemOID=$valuelistvar]/@Value (: the dependent variable value may not be null as "Mandatory='Yes'" :) where not($dependentvarvalue) return Variable {data($valuelistvarname)} valuelist value '{data($dependentvarvalue)}' is found to be null although the item is valuelist-mandatory for {data($whereclauseaboutitemname)}='{data($checkvalue)}' ]]> Value level datatype must match the datatype described in define.xml - Variable datatype is not %Variable.@Clause.DataType% when value-level condition occurs 3.0 3.1 ALL {data($valuelistvars)} :) (: iterate over the variables (OIDs) that do have an attached ValueList :) for $valuelistvar in $valuelistvars (: get the Name of the variable :) let $valuelistvarname := $definedoc//odm:ItemDef[@OID=$valuelistvar]/@Name (: get the reference valuelist itself :) let $valuelistoid := $definedoc//odm:ItemDef[@OID=$valuelistvar]/def:ValueListRef/@ValueListOID let $valuelist := $definedoc//def:ValueListDef[@OID=$valuelistoid] (: iterate over the ValueList ItemRefs :) for $valuelistitemref in $valuelist/odm:ItemRef[@Mandatory='Yes'] (: get the OID :) let $valuelistitemoid := $valuelistitemref/@ItemOID (: get the WhereClause :) let $whereclauserefoid := $valuelistitemref/def:WhereClauseRef/@WhereClauseOID (: and the corresponding WhereClauseDef :) let $whereclausedef := $definedoc//def:WhereClauseDef[@OID=$whereclauserefoid] (: get the item it is about - we currently only support 1 item and only the "EQ" comparator, and only the case that it is about data in the same dataset (e.g. STRESU depends of TESTCD value) This covers 90% of the cases :) let $whereclauseaboutitemoid := $whereclausedef/odm:RangeCheck/@def:ItemOID let $whereclauseaboutitemname := $definedoc//odm:ItemDef[@OID=$whereclauseaboutitemoid]/@Name let $checkvalue := $whereclausedef/odm:RangeCheck/odm:CheckValue/text() (: return {data($whereclauseaboutitemoid)} - {data($checkvalue)} :) (: pick up the corresponding ItemDef :) for $valuelistitemdef in $definedoc//odm:ItemDef[@OID=$valuelistitemoid] (: get the datatype :) let $datatype := $valuelistitemdef/@DataType (: get all the records in the dataset that are about the given valuelist variable :) (: return {data($valuelistvar)} - {data($whereclauseaboutitemoid)} - {data($checkvalue)} - {data($valuelistcodedvalues)} :) (: iterate over all the records where the WhereClause applies to, i.e. $whereclauseaboutitemoid = $checkvalue :) for $record in $datasetdoc//odm:ItemGroupData[odm:ItemData[@ItemOID=$whereclauseaboutitemoid and @Value=$checkvalue]] let $recnum := $record/@data:ItemGroupDataSeq (: get the value of the dependent variable :) let $itemvalue := $record/odm:ItemData[@ItemOID=$valuelistvar]/@Value (: the value must be according to the datatype :) (: define.xml allows following datatypes: text, integer, float, datetime, date, time, partialDate, partialTime, partialDatetime, incompleteDatetime, durationDatetime :) (: P.S. in case 'datetime' is expected but a correct date is provided, that is also ok :) let $isValidDataTypeValue := if ($datatype = 'text') then 'true' (: everything is text ... :) else if($datatype = 'integer' and $itemvalue castable as xs:integer) then 'true' else if($datatype = 'float' and $itemvalue castable as xs:double) then 'true' else if($datatype = 'datetime' and $itemvalue castable as xs:dateTime) then 'true' else if($datatype = 'date' and $itemvalue castable as xs:date or $itemvalue castable as xs:date) then 'true' else if($datatype = 'time' and $itemvalue castable as xs:time) then 'true' (: use function for partialDate :) else if($datatype = 'partialDate' and functx:isPartialDate($itemvalue)) then 'true' (: use function for partialTime :) else if($datatype = 'partialTime' and functx:isPartialTime($itemvalue)) then 'true' (: use function for partialDateTime :) else if($datatype = 'partialDateTime' and functx:isPartialDatetime($itemvalue)) then 'true' (: TODO: write function for incompleteDatetime :) else if($datatype = 'durationDatetime' and $itemvalue castable as xs:duration) then 'true' (: TODO: write function for other form of durationDatetime ("from-to" format) :) else 'false' (: when the value does not match the datatype, give an error :) where $isValidDataTypeValue = 'false' return Variable {data($valuelistvarname)} valuelist value '{data($itemvalue)}' is compatible with its data type '{data($datatype)}' ]]> Value level length must not exceed the length as specified define.xml Variable value is longer than defined max length %Variable.@Clause.Length% when value-level condition occurs 3.0 3.1 ALL {data($whereclauseaboutitemoid)} - {data($checkvalue)} :) (: pick up the corresponding ItemDef :) for $valuelistitemdef in $definedoc//odm:ItemDef[@OID=$valuelistitemoid] (: get the maximal length :) let $maxlength := $valuelistitemdef/@Length (: get all the records in the dataset that are about the given valuelist variable :) (: return {data($valuelistvar)} - {data($whereclauseaboutitemoid)} - {data($checkvalue)} - {data($valuelistcodedvalues)} :) (: iterate over all the records where the WhereClause applies to, i.e. $whereclauseaboutitemoid = $checkvalue :) for $record in $datasetdoc//odm:ItemGroupData[odm:ItemData[@ItemOID=$whereclauseaboutitemoid and @Value=$checkvalue]] let $recnum := $record/@data:ItemGroupDataSeq (: get the value of the dependent variable :) let $itemvalue := $record/odm:ItemData[@ItemOID=$valuelistvar]/@Value (: and get its length :) let $valuelength := string-length($itemvalue) (: real length should be less or equal than the maximum lenth :) where $valuelength > $maxlength return Variable {data($valuelistvarname)} valuelist value '{data($itemvalue)}' is longer than the allowed maximal length {data($maxlength)} ]]> The value for Study Day must not be negative for Exposure treatments - Study Day variables (*DY) value should not be negative in Exposure (EX) datasets 3.0 3.1 EX Value of {data($varname)} is not allowed to be negative in dataset {data($name)}. A value of {data($dyvalue)} was found ]]> Time Point Reference must be provided, when Reference Time Point is used Time Point Reference (--TPTREF) variable values should be provided, when Date/Time of Reference Time Point (--RFTDTC) variable values are populated 3.0 3.1 EX BG LB CL PC EG VS {data($tptrefname)} is not populated although {data($rftdtcname)} is populated ]]> --DTC must be provided, when --ENDTC is provided Date/Time of Collection (--DTC) should not be NULL, when End Date/Time of Observation (--ENDTC) is not NULL 3.0 3.1 FINDINGS Missing value for {data($dtcname)}, when {data($endtcname)} is provided, value={data($endtcvalue)} ]]> --DTC must be provided, when --ENDTC is provided Date/Time of Collection (--DTC) should not be NULL, when End Date/Time of Observation (--ENDTC) is not NULL 3.0 3.1 FINDINGS Missing value for {data($dtcname)}, when {data($endtcname)} is provided, value={data($endtcvalue)} ]]> RFXENDTC must be provided, when RFXSTDTC is provided Value for Date/Time of Last Study Treatment (RFXENDTC) variable must be populated, when Date/Time of First Study Treatment (RFXSTDTC) variable value is provided 3.1 DM RFXENDTC is not populated although RFXSTDTC is populated ]]> Value of --DUR, --ELTM, --EVLINT must conform to the ISO 8601 'duration' international standard Value of Duration, Elapsed Time, and Interval variables (--DUR, --ELTM, --EVLINT) must conform to the ISO 8601 international standard 3.0 3.1 ALL {data($durname)} - {data($eltmname)} - {data($evlintname)} :) (: iterate over all records that have either a value for --DUR, --ELTM or --EVLINT :) for $record in $datasetdoc[$duroid or $eltmoid or $evlintoid]//odm:ItemGroupData (: get the record number :) let $recnum := $record/@data:ItemGroupDataSeq (: iterate over all the datapoints --DUR, --ELTM, --EVLINT :) let $durdatapoints := $record/odm:ItemData[@ItemOID=$duroid or @ItemOID=$eltmoid or @ItemOID=$evlintoid] for $datapoint in $durdatapoints (: get the value :) let $value := $datapoint/@Value (: we need the name of the datapoint in the define.xml for reporting :) let $itemoid := $datapoint/@ItemOID let $itemname := $definedoc//odm:ItemDef[@OID=$itemoid]/@Name (: the value must be a valid ISO-8601 "duration" :) (: IMPORTANT: PnW and -PnW are rejected as valid ISO-8601 durations, so we need to take care of that :) (: TODO: check the "n" is an integer :) where not($value castable as xs:duration) and not((starts-with($value,'P') or starts-with($value,'-P')) and ends-with($value,'W')) return Invalid (non-ISO8601 duration) value='{data($value)}' ]]> Value for --STNRHI may not be less than value for --STNRLO Reference Range Upper Limit-Std Units (--STNRHI) value must be greater than or equal to Reference Range Lower Limit-Std Units (--STNRLO) value 3.0 3.1 FINDINGS Value for {data($stnrihname)}, value={data($stnrhivalue)} is less than value for {data($stnrloname)}, value={data($stnrlovalue)} ]]> Value for --STNRHI may not be less than value for --STNRLO Reference Range Upper Limit-Std Units (--STNRHI) value must be greater than or equal to Reference Range Lower Limit-Std Units (--STNRLO) value 3.0 3.1 FINDINGS Value for {data($stnrihname)}, value={data($stnrhivalue)} is less than value for {data($stnrloname)}, value={data($stnrlovalue)} ]]> Value for –DOSE may not be negative Non-missing Dose (--DOSE) value must be greater than or equal to 0 INTERVENTIONS 3.0 3.1 = 0 :) where $dosevalue and number($dosevalue) < 0 return Negative value for {data($dosename)} in dataset {data($datasetname)}: {data($dosevalue)} was found ]]> Value for –DOSE may not be negative Non-missing Dose (--DOSE) value must be greater than or equal to 0 3.0 3.1 INTERVENTIONS = 0 :) where $dosevalue and number($dosevalue) < 0 return Negative value for {data($dosename)} in dataset {data($datasetname)}: {data($dosevalue)} was found ]]> Value for --DUR may not be negative Non-missing Duration of Event, Exposure or Observation (--DUR) value must be greater than or equal to 0 3.0 3.1 INTERVENTIONS EVENTS FINDINGS TE SE SV = 0 :) where $durvalue and starts-with($durvalue,'-') (: a --DUR value is present and it is a -P so negative value :) return Negative value for {data($durname)} in dataset {data($datasetname)}: {data($durvalue)} was found ]]> Value for --DUR may not be negative Non-missing Duration of Event, Exposure or Observation (--DUR) value must be greater than or equal to 0 3.0 3.1 INTERVENTIONS EVENTS FINDINGS TE SE SV = 0 :) where $durvalue and starts-with($durvalue,'-') (: a --DUR value is present and it is a -P so negative value :) return Negative value for {data($durname)} in dataset {data($datasetname)}: {data($durvalue)} was found ]]> The value for AGE may not be negative The value of Age (AGE) cannot be less than 0 3.0 3.1 DM = 0 :) where $agevalue and number($agevalue) < 0 return Negative value for AGE in DM dataset {data($dmdatasetname)}: {data($agevalue)} was found ]]> Only ASCII characters in variables are allowed Variables value must not include non-ASCII or non-printable characters (outside of 32-126 ASCII code range), limited to variables which values may be converted into new variable name or label (--TEST, --TESTCD, --PARM, --PARMCD, QLABEL, QNAM) 3.0 3.1 ALL 0, the all the characters must be ASCII - see e.g. https://stackoverflow.com/questions/51521676/use-xpath-to-check-if-a-string-has-only-ascii-characters :) where string-length($varvalue) > 0 and not(matches($varvalue,'^[ -~\n\t]+$')) return Variable value '{data($varvalue)}' contains non-ASCII characters ]]> Value for --STRESC may not be populated, when --STAT is 'NOT DONE' Status (--STAT) should be NULL, when Standardized Result in Character Format (--STRESC ) is provided 3.0 3.1 SC BW BG FW LB DD CL MI MA OM PM PC PP TF EG VS Status {data($statname)} should be NULL, when Result or Finding in Original Units ({data($strescname)}) is provided ]]> Value for --ORRES may not be populated, when --STAT is 'NOT DONE' Value of Original Result (--ORRES) variable is expected to be missing, when observation was not performed (Status (--STAT) is 'NOT DONE') 3.0 3.1 FINDINGS {data($orresname)} value is populated (value={data($orresvalue)}), when {data($orresname)} is 'NOT DONE' ]]> Value for --ORRES may not be populated, when --STAT is 'NOT DONE' Value of Original Result (--ORRES) variable is expected to be missing, when observation was not performed (Status (--STAT) is 'NOT DONE') 3.0 3.1 FINDINGS {data($orresname)} value is populated (value={data($orresvalue)}), when {data($orresname)} is 'NOT DONE' ]]> Value for --REASND must be present, when --STAT is 'NOT DONE' Value of Reason Not Done (--REASND) variable should be populated, when Status (--STAT) variable value is 'NOT DONE' 3.0 3.1 INTERVENTIONS EVENTS FINDINGS Missing value for {data($reasndname)} when {data($statname)}={data($statvalue)} in dataset {data($datasetname)} ]]> Value for --REASND must be present, when --STAT is 'NOT DONE' Value of Reason Not Done (--REASND) variable should be populated, when Status (--STAT) variable value is 'NOT DONE' 3.0 3.1 INTERVENTIONS EVENTS FINDINGS Missing value for {data($reasndname)} when {data($statname)}={data($statvalue)} in dataset {data($datasetname)} ]]> One of --STDTC, --STRF or --STRTPT must be populated, when --ENDTC, --ENRF or --ENRTPT is provided Start Date/Time of Observation (--STDTC), Start Relative to Reference Period (--STRF) or Start Relative to Reference Time Point (--STRTPT) should not be NULL, when End Date/Time of Observation (--ENDTC), End Relative to Reference Period (--ENRF) or End Relative to Reference Time Period (--ENRTPT) is not NULL 3.0 3.1 INTERVENTIONS EVENTS SE SV Missing values for {data(concat($name,'STDTC'))}, {data(concat($name,'STRF'))} and {data(concat($name,'STRTPT'))}, when one of {data(concat($name,'ENDTC'))}, {data(concat($name,'ENRF'))} or {data(concat($name,'ENRTPT'))} is provided in dataset {data($name)} ]]> One of --STDTC, --STRF or --STRTPT must be populated, when --ENDTC, --ENRF or --ENRTPT is provided Start Date/Time of Observation (--STDTC), Start Relative to Reference Period (--STRF) or Start Relative to Reference Time Point (--STRTPT) should not be NULL, when End Date/Time of Observation (--ENDTC), End Relative to Reference Period (--ENRF) or End Relative to Reference Time Period (--ENRTPT) is not NULL 3.0 3.1 INTERVENTIONS EVENTS SE SV Missing values for {data(concat($name,'STDTC'))}, {data(concat($name,'STRF'))} and {data(concat($name,'STRTPT'))}, when one of {data(concat($name,'ENDTC'))}, {data(concat($name,'ENRF'))} or {data(concat($name,'ENRTPT'))} is provided in dataset {data($name)} ]]> --STTPT must be populated, when --STRTPT is populated Start Reference Time Point (--STTPT) must not be NULL, when Start Relative to Reference Time Point (--STRTPT) is provided 3.0 3.1 INTERVENTIONS EVENTS FINDINGS SV SE Missing value for {data($sttptname)}, when {data($strtptname)} is populated, value = {data($strtptvalue)} ]]> --STTPT must be populated, when --STRTPT is populated Start Reference Time Point (--STTPT) must not be NULL, when Start Relative to Reference Time Point (--STRTPT) is provided 3.0 3.1 INTERVENTIONS EVENTS FINDINGS SV SE Missing value for {data($sttptname)}, when {data($strtptname)} is populated, value = {data($strtptvalue)} ]]> --ENTPT must be populated, when --ENRTPT is populated End Reference Time Point (--ENTPT) must not be NULL, when End Relative to Reference Time Point (--ENRTPT) is provided 3.0 3.1 ALL Missing value for {data($entptname)}, when {data($enrtptname)} is populated, value = {data($enrtptvalue)} ]]> --ENTPT must be populated, when --ENRTPT is populated End Reference Time Point (--ENTPT) must not be NULL, when End Relative to Reference Time Point (--ENRTPT) is provided 3.0 3.1 ALL Missing value for {data($entptname)}, when {data($enrtptname)} is populated, value = {data($enrtptvalue)} ]]> 'Control Type' (TCNTRL) record must be populated in Trial Sets (TX) domain There must be a record with TXPARMCD = TCNTRL 3.0 3.1 TS No PARAMCD=TCNTRL record was found ]]> 'Arm Code' (ARMCD) records must be populated in Trial Sets (TX) domain There must be a record with TXPARMCD = TCNTRL 3.0 3.1 TS No PARAMCD=ARMCD record was found ]]> 'Sponsor-Defined Group Code' (SPGRPCD) records must be populated in Trial Sets (TX) domain There must be a record with TXPARMCD = TCNTRL 3.0 3.1 TS No PARAMCD=SPGRPCD record was found ]]> 'Group Label' (GRPLBL) records must be populated in Trial Sets (TX) domain There must be a record with TXPARMCD = TCNTRL 3.0 3.1 TS No PARAMCD=GRPLBL record was found ]]> 'Dose Level' (TRTDOS) records must be populated in Trial Sets (TX) domain There must be a record with TXPARMCD = TCNTRL 3.0 3.1 TS No PARAMCD=TRTDOS record was found ]]> 'Dose Units' (TRTDOSU) records must be populated in Trial Sets (TX) domain There must be a record with TXPARMCD = TCNTRL 3.0 3.1 TS No PARAMCD=TRTDOSU record was found ]]> Set Code (SETCD) values must match entries in the Trial Sets (TX) dataset 3.0 3.1 DM DM.SETCD value '{data($dmsetcdvalue)}' cannot be found in TX ]]> The value of Parameter Code (TXPARMCD) variable must be unique for each Trial Set (SETCD) within the Trial Sets (TX) domain 3.0 3.1 TX 1 return Duplicate value '{data($txparmcdvalue)}' for records {data($recnums)} for SETCD='{data($setcdvalue)}' in TX ]]> Variable Data Types in the dataset should match the variable data types described in SEND IG and SDTM Model 3.0 3.1 ALL , $cdisclibraryquerysdtmmodel):) (: CDISC Library query to the SEND-IG :) let $cdisclibraryquerysendig := concat($cdisclibrarybase,'sendig/',$sendigversion,'/classes/',$class) let $cdisclibraryresponsesendig := http:send-request(, $cdisclibraryquerysendig) (: Iterate over all dataset definitions :) for $itemgroupdef in $group/odm:ItemGroupDef (: get name, domain and class :) let $name := $itemgroupdef/@Name let $domainname := $itemgroupdef/@Domain (: iterate over all variables within the domain :) for $itemrefoid in $itemgroupdef/odm:ItemRef/@ItemOID let $varname := $definedoc//odm:ItemDef[@OID=$itemrefoid]/@Name (: we need to take generic variable names into account, e.g. LBDTC goes into --DTC :) let $varnamegen := ( if(starts-with($varname,$domainname)) then concat('--',substring($varname,3)) else $varname ) let $definedatatype := $definedoc//odm:ItemDef[@OID=$itemrefoid]/@DataType (: look up the name in the CDISC Library response and get the XPT simple datatype :) let $simpledatatype := ($cdisclibraryresponsesendig/json//*/simpleDatatype[../name=$varname or ../name=$varnamegen])[1] (: When the simple datatype is 'Num', we require Define-XML datatype 'integer', 'float' or 'double' :) (: When the simple datatype is 'Char', we require Define-XML datatype NOT to be 'integer', 'float' or 'double' :) where ($simpledatatype = 'Num' and not($definedatatype='integer' or $definedatatype='float' or $definedatatype='double')) or ($simpledatatype = 'Char' and ($definedatatype='integer' or $definedatatype='float' or $definedatatype='double')) return Dataset datatype '{data($definedatatype)}' does not correspond to expected SEND-IG datatype '{data($simpledatatype)}' ]]> Variable Label in the dataset should match the variable label described in SEND IG 3.0 3.1 ALL , $cdisclibrarygeneralobservationsquery) (: Order all dataset definitions per def:Class, so that we need only 1 CDISC-Library call per class :) let $groupeditemgroupdefs := ( if($defineversion = '2.1') then for $itemgroup in $definedoc//odm:ItemGroupDef group by $a := $itemgroup/def21:Class/@Name return element group { $itemgroup } else for $itemgroup in $definedoc//odm:ItemGroupDef group by $a := $itemgroup/@def:Class return element group { $itemgroup } ) (: iterate over the groups - in each group, all dataset definitions (ItemGroupDef) have the same value for def:Class :) for $group in $groupeditemgroupdefs let $defclass := ( if($defineversion = '2.1') then $group/odm:ItemGroupDef[1]/def21:Class/@Name else $group/odm:ItemGroupDef[1]/@def:Class ) (: Unfortunately, the way of writing the class name (casing) has not always been consistent within CDISC :) let $class := ( if(upper-case($defclass)= 'FINDINGS') then 'Findings' else if (upper-case($defclass)= 'EVENTS') then 'Events' else if (upper-case($defclass)= 'INTERVENTIONS') then 'Interventions' else if (starts-with(upper-case($defclass),'TRIAL')) then 'TrialDesign' else if (ends-with(upper-case($defclass),'ABOUT')) then 'FindingsAbout' else if (starts-with(upper-case($defclass),'SPECIAL')) then 'SpecialPurpose' else if (starts-with(upper-case($defclass),'RELAT')) then 'Relationship' else 'GeneralObservations' ) (: CDISC Library query to the SDTM MODEL :) (: let $cdisclibraryquerysdtmmodel := concat($cdisclibrarybase,'sdtm/',$sdtmversion,'/classes/',$class) :) (: now run the CDISC Library query as it requires basic authentication, we need to use the EXPath 'http-client' extension :) (: let $cdisclibraryresponsesdtmmodel := http:send-request(, $cdisclibraryquerysdtmmodel):) (: CDISC Library query to the SEND-IG :) let $cdisclibraryquerysendig := concat($cdisclibrarybase,'sendig/',$sendigversion,'/classes/',$class) let $cdisclibraryresponsesendig := http:send-request(, $cdisclibraryquerysendig) (: Iterate over all dataset definitions :) for $itemgroupdef in $group/odm:ItemGroupDef (: get name, domain and class :) let $name := $itemgroupdef/@Name let $domainname := $itemgroupdef/@Domain (: iterate over all variables within the domain :) for $itemrefoid in $itemgroupdef/odm:ItemRef/@ItemOID let $varname := $definedoc//odm:ItemDef[@OID=$itemrefoid]/@Name (: we need to take generic variable names into account, e.g. LBDTC goes into --DTC :) let $varnamegen := ( if(starts-with($varname,$domainname)) then concat('--',substring($varname,3)) else $varname ) let $varlabel := ( if($definedoc//odm:ItemDef[@OID=$itemrefoid]/odm:Description/odm:TranslatedText[1]) then $definedoc//odm:ItemDef[@OID=$itemrefoid]/odm:Description/odm:TranslatedText[1] else $definedoc//odm:ItemDef[@OID=$itemrefoid]/@def:Label ) (: look up the name in the CDISC Library response and get the expected variable label :) let $expectedvarlabel := ( (: first look into the response from the SEND-IG :) if($cdisclibraryresponsesendig/json//*/label[../name=$varname or ../name=$varnamegen]) then ($cdisclibraryresponsesendig/json//*/label[../name=$varname or ../name=$varnamegen])[1] (: If not found, look in the SDTM model 'GeneralObservations' :) else ($cdisclibrarygeneralobservationsresponse/json//*/label[../name=$varname or ../name=$varnamegen])[1] ) (: give an error when real and expected label differ :) where not($varlabel = $expectedvarlabel) return Label '{data($varlabel)}' does not correspond to expected SEND-IG label '{data($expectedvarlabel)}' ]]> AGETXT must be provided in number-number format Age Range (AGETXT) variable values should be populated with 'number-number' format 3.0 3.1 DM Invalid value for AGETXT. '{data($agetxtvalue)}' was found ]]> Pool ID (POOLID) values should match entries in the Pool Definition (POOLDEF) dataset 3.0 3.1 EX CL FW LB PC PP RELREC SUPPQUAL POOLID value '{data($poolidvalue)}' is not found as a POOLDEF.POOLID value ]]> Study Day variables (*DY) value may not equal 0 Study Day variables (*DY) value should not equal 0 3.0 3.1 INTERVENTIONS EVENTS FINDINGS DM SE SV Value of Study Day {data($dyname)} variable equals 0 ]]> Study Day variables (*DY) value may not equal 0 Study Day variables (*DY) value should not equal 0 3.0 3.1 INTERVENTIONS EVENTS FINDINGS DM SE SV Value of Study Day {data($dyname)} variable equals 0 ]]> --DY variable value must be correctly calculated Collection Study Day (--DY) variable value should be populated as defined by CDISC standards: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC 3.0 3.1 INTERVENTIONS EVENTS FINDINGS ) (: iterate over all other provided datasets within INTERVENTIONS, EVENTS, FINDINGS :) for $dataset in $definedoc//odm:ItemGroupDef[not(@Name='DM')][upper-case(@def:Class)='INTERVENTIONS' or upper-case(@def:Class)='EVENTS' or upper-case(@def:Class)='FINDINGS' or upper-case(./def21:Class/@Name)='INTERVENTIONS' or upper-case(./def21:Class/@Name)='EVENTS' or upper-case(./def21:Class/@Name)='FINDINGS'] let $name := $dataset/@Name let $dsname := ( if($defineversion='2.1') then $dataset/def21:leaf/@xlink:href else $dataset/def:leaf/@xlink:href ) let $datasetdoc := ( if($dsname) then doc(concat($base,$dsname)) else () ) (: Get the OIDs of the --DY and --DTC variables :) let $dyoid := ( for $a in $definedoc//odm:ItemDef[ends-with(@Name,'DY') and string-length(@Name)=4]/@OID where $a = $definedoc//odm:ItemGroupDef[@Name=$name]/odm:ItemRef/@ItemOID return $a ) let $dyname := concat($name,'DY') let $dtcoid := ( for $a in $definedoc//odm:ItemDef[ends-with(@Name,'DTC') and string-length(@Name)=5]/@OID where $a = $definedoc//odm:ItemGroupDef[@Name=$name]/odm:ItemRef/@ItemOID return $a ) let $dtcname := $definedoc//odm:ItemDef[@OID=$dtcoid]/@Name (: and the OID of the USUBJID variable (might be different from the one in DM) :) let $usubjidoid := ( for $a in $definedoc//odm:ItemDef[@Name='USUBJID']/@OID where $a = $definedoc//odm:ItemGroupDef[@Name=$name]/odm:ItemRef/@ItemOID return $a ) for $record in $datasetdoc//odm:ItemGroupData[odm:ItemData[@ItemOID=$dtcoid]] let $recnum := $record/@data:ItemGroupDataSeq (: get the USUBJID value :) let $usubjidvalue := $record/odm:ItemData[@ItemOID=$usubjidoid]/@Value (: get the --DTC value :) let $dtcvalue := $record/odm:ItemData[@ItemOID=$dtcoid]/@Value (: and check whether it is a complete date - i.e. string-length at least 10 :) let $iscompletedtcvalue := string-length($dtcvalue) >= 10 (: boolean :) (: look up the record in the DM dataset and get the RFSTDTC :) (: keeping worst case scenario into account that there are two records for the same USUBJID in DM - take the first :) (: let $rfstdtcvalue := doc($dmdatasetlocation)//odm:ItemGroupData[odm:ItemData[@ItemOID=$dmusubjidoid and @Value=$usubjidvalue]][1]/odm:ItemData[@ItemOID=$rfstdtcoid]/@Value :) (: replacement 2019-08-19: more efficient :) let $rfstdtcvalue := $usubjidrfstdtcpairs[@usubjid=$usubjidvalue]/@rfstdtc (: and check whether also RFSTDTC is complete :) let $iscompleterfstdtcvalue := string-length($rfstdtcvalue) >= 10 (: boolean :) let $dyvalue := $record/odm:ItemData[@ItemOID=$dyoid]/@Value (: now calculate the DY value but only when RFSTDTC and DTC have a complete date part :) let $dycalculated := ( if ($iscompleterfstdtcvalue and $iscompletedtcvalue) then (: if there is one, we must strip off the time part :) let $dtcvalueshort := substring($dtcvalue,1,10) let $rfstdtcvalueshort := substring($rfstdtcvalue,1,10) let $dycalc := ( if($dtcvalueshort castable as xs:date and $rfstdtcvalueshort castable as xs:date) then days-from-duration(xs:date($dtcvalueshort)-xs:date($rfstdtcvalueshort)) else() ) return $dycalc else () (: one or both dates are not complete dates :) ) (: for the FDA there is no day 0, DY can only be <0 or >0, first day is day 1 :) let $dycalculatedfda := ( if($dycalculated >= 0) then $dycalculated + 1 else ( $dycalculated ) ) (: before comparing, check that the DY value is really an integer :) where $dyvalue castable as xs:integer and $dycalculatedfda and $dyvalue and not($dycalculatedfda = $dyvalue) return Invalid value for {data($dyname)}, calculated value={data($dycalculatedfda)}, provided value={data($dyvalue)}, in dataset {data($name)} ]]> --DY variable value must be correctly calculated Collection Study Day (--DY) variable value should be populated as defined by CDISC standards: --DY = (date portion of --DTC) - (date portion of RFSTDTC) +1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC 3. 3.1 INTERVENTIONS EVENTS FINDINGS ) (: iterate over all other provided datasets within INTERVENTIONS, EVENTS, FINDINGS :) for $dataset in $definedoc//odm:ItemGroupDef[@Name=$datasetname][not(@Name='DM')][upper-case(@def:Class)='INTERVENTIONS' or upper-case(@def:Class)='EVENTS' or upper-case(@def:Class)='FINDINGS' or upper-case(./def21:Class/@Name)='INTERVENTIONS' or upper-case(./def21:Class/@Name)='EVENTS' or upper-case(./def21:Class/@Name)='FINDINGS'] let $name := $dataset/@Name let $dsname := ( if($defineversion='2.1') then $dataset/def21:leaf/@xlink:href else $dataset/def:leaf/@xlink:href ) let $datasetdoc := ( if($dsname) then doc(concat($base,$dsname)) else () ) (: Get the OIDs of the --DY and --DTC variables :) let $dyoid := ( for $a in $definedoc//odm:ItemDef[ends-with(@Name,'DY') and string-length(@Name)=4]/@OID where $a = $definedoc//odm:ItemGroupDef[@Name=$name]/odm:ItemRef/@ItemOID return $a ) let $dyname := concat($name,'DY') let $dtcoid := ( for $a in $definedoc//odm:ItemDef[ends-with(@Name,'DTC') and string-length(@Name)=5]/@OID where $a = $definedoc//odm:ItemGroupDef[@Name=$name]/odm:ItemRef/@ItemOID return $a ) let $dtcname := $definedoc//odm:ItemDef[@OID=$dtcoid]/@Name (: and the OID of the USUBJID variable (might be different from the one in DM) :) let $usubjidoid := ( for $a in $definedoc//odm:ItemDef[@Name='USUBJID']/@OID where $a = $definedoc//odm:ItemGroupDef[@Name=$name]/odm:ItemRef/@ItemOID return $a ) for $record in $datasetdoc//odm:ItemGroupData[odm:ItemData[@ItemOID=$dtcoid]] let $recnum := $record/@data:ItemGroupDataSeq (: get the USUBJID value :) let $usubjidvalue := $record/odm:ItemData[@ItemOID=$usubjidoid]/@Value (: get the --DTC value :) let $dtcvalue := $record/odm:ItemData[@ItemOID=$dtcoid]/@Value (: and check whether it is a complete date - i.e. string-length at least 10 :) let $iscompletedtcvalue := string-length($dtcvalue) >= 10 (: boolean :) (: look up the record in the DM dataset and get the RFSTDTC :) (: keeping worst case scenario into account that there are two records for the same USUBJID in DM - take the first :) (: let $rfstdtcvalue := doc($dmdatasetlocation)//odm:ItemGroupData[odm:ItemData[@ItemOID=$dmusubjidoid and @Value=$usubjidvalue]][1]/odm:ItemData[@ItemOID=$rfstdtcoid]/@Value :) (: replacement 2019-08-19: more efficient :) let $rfstdtcvalue := $usubjidrfstdtcpairs[@usubjid=$usubjidvalue]/@rfstdtc (: and check whether also RFSTDTC is complete :) let $iscompleterfstdtcvalue := string-length($rfstdtcvalue) >= 10 (: boolean :) let $dyvalue := $record/odm:ItemData[@ItemOID=$dyoid]/@Value (: now calculate the DY value but only when RFSTDTC and DTC have a complete date part :) let $dycalculated := ( if ($iscompleterfstdtcvalue and $iscompletedtcvalue) then (: if there is one, we must strip off the time part :) let $dtcvalueshort := substring($dtcvalue,1,10) let $rfstdtcvalueshort := substring($rfstdtcvalue,1,10) let $dycalc := ( if($dtcvalueshort castable as xs:date and $rfstdtcvalueshort castable as xs:date) then days-from-duration(xs:date($dtcvalueshort)-xs:date($rfstdtcvalueshort)) else() ) return $dycalc else () (: one or both dates are not complete dates :) ) (: for the FDA there is no day 0, DY can only be <0 or >0, first day is day 1 :) let $dycalculatedfda := ( if($dycalculated >= 0) then $dycalculated + 1 else ( $dycalculated ) ) (: before comparing, check that the DY value is really an integer :) where $dyvalue castable as xs:integer and $dycalculatedfda and $dyvalue and not($dycalculatedfda = $dyvalue) return Invalid value for {data($dyname)}, calculated value={data($dycalculatedfda)}, provided value={data($dyvalue)}, in dataset {data($name)} ]]> --DY variable value must be populated Collection Study Day (--DY) variable value should be populated, when Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both of them include complete date part 3.0 3.1 INTERVENTIONS EVENTS FINDINGS = 10 return $record/odm:ItemData[@ItemOID=$dmusubjidoid]/@Value ) (: iterate over all other datasets in INTERVENTIONS, EVENTS, FINDINGS :) for $dataset in $definedoc//odm:ItemGroupDef[upper-case(@def:Class)='INTERVENTIONS' or upper-case(@def:Class)='EVENTS' or upper-case(@def:Class)='FINDINGS' or upper-case(./def21:Class/@Name)='INTERVENTIONS' or upper-case(./def21:Class/@Name)='EVENTS' or upper-case(./def21:Class/@Name)='FINDINGS'] let $name := $dataset/@Name let $datasetname := ( if($defineversion='2.1') then $dataset/def21:leaf/@xlink:href else $dataset/def:leaf/@xlink:href ) let $datasetdoc := ( if($datasetname) then doc(concat($base,$datasetname)) else () ) (: Get the OIDs of the --DY and --DTC variables :) let $dyoid := ( for $a in $definedoc//odm:ItemDef[ends-with(@Name,'DY') and string-length(@Name)=4]/@OID where $a = $definedoc//odm:ItemGroupDef[@Name=$name]/odm:ItemRef/@ItemOID return $a ) let $dyname := concat($name,'DY') let $dtcoid := ( for $a in $definedoc//odm:ItemDef[ends-with(@Name,'DTC') and string-length(@Name)=5]/@OID where $a = $definedoc//odm:ItemGroupDef[@Name=$name]/odm:ItemRef/@ItemOID return $a ) let $dtcname := $definedoc//odm:ItemDef[@OID=$dtcoid]/@Name (: and the OID of the USUBJID variable (might be different from the one in DM) :) let $usubjidoid := ( for $a in $definedoc//odm:ItemDef[@Name='USUBJID']/@OID where $a = $definedoc//odm:ItemGroupDef[@Name=$name]/odm:ItemRef/@ItemOID return $a ) (: iterate over all records but only when --DY and --DTC have been defined :) for $record in $datasetdoc[$dtcoid and $dyoid]//odm:ItemGroupData[odm:ItemData[@ItemOID=$dtcoid]] let $recnum := $record/@data:ItemGroupDataSeq (: get the USUBJID value :) let $usubjidvalue := $record/odm:ItemData[@ItemOID=$usubjidoid]/@Value (: get the --DTC value :) let $dtcvalue := $record/odm:ItemData[@ItemOID=$dtcoid]/@Value (: and check whether it is a complete date - i.e. string-length at least 10 :) let $iscompletedtcvalue := string-length($dtcvalue) >= 10 (: boolean :) (: look up the record in the DM dataset and get the RFSTDTC :) (: and check whether also RFSTDTC is complete :) let $hascompleterfstdtcvalue := functx:is-value-in-sequence($usubjidvalue,$usubjidcompleterfstdtc) let $dyvalue := $record/odm:ItemData[@ItemOID=$dyoid]/@Value (: when RFSTDTC and xxDTC are complete, there MUST be a xxDY value :) where $iscompletedtcvalue and $hascompleterfstdtcvalue and not($dyvalue) return {data($dyname)} is absent although both {data($dtcname)} (value={data($dtcvalue)}) and RFSTDTC contain complete dates ]]> --DY variable value must be populated Collection Study Day (--DY) variable value should be populated, when Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both of them include complete date part 3.0 3.1 INTERVENTIONS EVENTS FINDINGS = 10 return $record/odm:ItemData[@ItemOID=$dmusubjidoid]/@Value ) (: iterate over all provided datasets in INTERVENTIONS, EVENTS, FINDINGS :) for $dataset in $definedoc//odm:ItemGroupDef[@Name=$datasetname][upper-case(@def:Class)='INTERVENTIONS' or upper-case(@def:Class)='EVENTS' or upper-case(@def:Class)='FINDINGS' or upper-case(./def21:Class/@Name)='INTERVENTIONS' or upper-case(./def21:Class/@Name)='EVENTS' or upper-case(./def21:Class/@Name)='FINDINGS'] let $name := $dataset/@Name let $datasetname := ( if($defineversion='2.1') then $dataset/def21:leaf/@xlink:href else $dataset/def:leaf/@xlink:href ) let $datasetdoc := ( if($datasetname) then doc(concat($base,$datasetname)) else () ) (: Get the OIDs of the --DY and --DTC variables :) let $dyoid := ( for $a in $definedoc//odm:ItemDef[ends-with(@Name,'DY') and string-length(@Name)=4]/@OID where $a = $definedoc//odm:ItemGroupDef[@Name=$name]/odm:ItemRef/@ItemOID return $a ) let $dyname := concat($name,'DY') let $dtcoid := ( for $a in $definedoc//odm:ItemDef[ends-with(@Name,'DTC') and string-length(@Name)=5]/@OID where $a = $definedoc//odm:ItemGroupDef[@Name=$name]/odm:ItemRef/@ItemOID return $a ) let $dtcname := $definedoc//odm:ItemDef[@OID=$dtcoid]/@Name (: and the OID of the USUBJID variable (might be different from the one in DM) :) let $usubjidoid := ( for $a in $definedoc//odm:ItemDef[@Name='USUBJID']/@OID where $a = $definedoc//odm:ItemGroupDef[@Name=$name]/odm:ItemRef/@ItemOID return $a ) (: iterate over all records but only when --DY and --DTC have been defined :) for $record in $datasetdoc[$dtcoid and $dyoid]//odm:ItemGroupData[odm:ItemData[@ItemOID=$dtcoid]] let $recnum := $record/@data:ItemGroupDataSeq (: get the USUBJID value :) let $usubjidvalue := $record/odm:ItemData[@ItemOID=$usubjidoid]/@Value (: get the --DTC value :) let $dtcvalue := $record/odm:ItemData[@ItemOID=$dtcoid]/@Value (: and check whether it is a complete date - i.e. string-length at least 10 :) let $iscompletedtcvalue := string-length($dtcvalue) >= 10 (: boolean :) (: look up the record in the DM dataset and get the RFSTDTC :) (: and check whether also RFSTDTC is complete :) let $hascompleterfstdtcvalue := functx:is-value-in-sequence($usubjidvalue,$usubjidcompleterfstdtc) let $dyvalue := $record/odm:ItemData[@ItemOID=$dyoid]/@Value (: when RFSTDTC and xxDTC are complete, there MUST be a xxDY value :) where $iscompletedtcvalue and $hascompleterfstdtcvalue and not($dyvalue) return {data($dyname)} is absent although both {data($dtcname)} (value={data($dtcvalue)}) and RFSTDTC contain complete dates ]]> --DY variable value may not be imputed --DY variable may be only populated, when both Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided and both of them include complete date part 3.0 3.1 INTERVENTIONS EVENTS FINDINGS CO SE SV = 10 (: boolean :) (: look up the record in the DM dataset and get the RFSTDTC :) (: keeping worst case scenario into account that there are two records for the same USUBJID in DM - take the first :) (: let $rfstdtcvalue := doc($dmdatasetlocation)//odm:ItemGroupData[odm:ItemData[@ItemOID=$dmusubjidoid and @Value=$usubjidvalue]][1]/odm:ItemData[@ItemOID=$rfstdtcoid]/@Value :) (: and check whether also RFSTDTC is complete :) let $hascompleterfstdtcvalue := functx:is-value-in-sequence($usubjidvalue,$usubjidincompleterfstdtc) let $dyvalue := $record/odm:ItemData[@ItemOID=$dyoid]/@Value (: when one of RFSTDTC and xxDTC is not complete, there may NOT be a xxDY value :) where (not($iscompletedtcvalue) or $hascompleterfstdtcvalue) and $dyvalue return {data($dyname)} is imputed (value={data($dyvalue)}) although one of {data($dtcname)} (value={data($dtcvalue)}) or RFSTDTC is not a complete date ]]> --DY variable value may not be imputed --DY variable may be only populated, when both Collection Study Date/Time (--DTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided and both of them include complete date part 3.0 3.1 INTERVENTIONS EVENTS FINDINGS CO SE SV = 10 (: boolean :) (: look up the record in the DM dataset and get the RFSTDTC :) (: keeping worst case scenario into account that there are two records for the same USUBJID in DM - take the first :) (: let $rfstdtcvalue := doc($dmdatasetlocation)//odm:ItemGroupData[odm:ItemData[@ItemOID=$dmusubjidoid and @Value=$usubjidvalue]][1]/odm:ItemData[@ItemOID=$rfstdtcoid]/@Value :) (: and check whether also RFSTDTC is complete :) let $hasincompleterfstdtcvalue := functx:is-value-in-sequence($usubjidvalue,$usubjidincompleterfstdtc) let $dyvalue := $record/odm:ItemData[@ItemOID=$dyoid]/@Value (: when one of RFSTDTC and xxDTC is not complete, there may NOT be a xxDY value :) where (not($iscompletedtcvalue) or $hasincompleterfstdtcvalue) and $dyvalue return {data($dyname)} is imputed (value={data($dyvalue)}) although one of {data($dtcname)} (value={data($dtcvalue)}) or RFSTDTC is not a complete date ]]> --TPTREF must be provided, when --ELTM is provided Time Point Reference (--TPTREF) should not be NULL, when Planned Elapsed Time from Time Point Ref (--ELTM) is populated 3.0 3.1 INTERVENTIONS EVENTS FINDINGS Missing value for {data($tptrefname)} when {data($eltmname)} is populated, value={data($eltmvalue)} ]]> --TPTREF must be provided, when --ELTM is provided Time Point Reference (--TPTREF) should not be NULL, when Planned Elapsed Time from Time Point Ref (--ELTM) is populated 3.1.2 3.1.3 3.2 INTERVENTIONS EVENTS FINDINGS Missing value for {data($tptrefname)} when {data($eltmname)} is populated, value={data($eltmvalue)} ]]> EPOCH value must match an entry in TA Epoch (EPOCH) values in all datasets should match entries in the Trial Arms (TA) dataset 3.0 3.1 ALL Invalid EPOCH. Value for EPOCH={data($epochvalue)} in dataset {data($datasetname)} was not found in the TA dataset {data($tadatasetname)} ]]> EPOCH value must match an entry in TA Epoch (EPOCH) values in all datasets should match entries in the Trial Arms (TA) dataset 3.0 3.1 ALL Invalid EPOCH. Value for EPOCH={data($epochvalue)} in dataset {data($datasetname)} was not found in the TA dataset {data($tadatasetname)} ]]> Variable appearing in dataset must be in the SDTM model Only variables listed in SDTM model should appear in a dataset. New sponsor defined variables must not be added, and existing variables must not be renamed or modified 3.0 3.1 ALL , $cdisclibrarygeneralobservationsquery) (: In order to minimize the number of calls to the CDISC Library, we group all dataset definition by def:Class :) (: Order all dataset definitions per def:Class, so that we need only 1 CDISC-Library call per class :) let $groupeditemgroupdefs := ( if($defineversion = '2.1') then for $itemgroup in $definedoc//odm:ItemGroupDef group by $a := $itemgroup/def21:Class/@Name return element group { $itemgroup } else for $itemgroup in $definedoc//odm:ItemGroupDef group by $a := $itemgroup/@def:Class return element group { $itemgroup } ) (: iterate over the groups - in each group, all dataset definitions (ItemGroupDef) have the same value for def:Class :) for $group in $groupeditemgroupdefs let $defclass := ( if($defineversion = '2.1') then $group/odm:ItemGroupDef[1]/def21:Class/@Name else $group/odm:ItemGroupDef[1]/@def:Class ) (: Unfortunately, the way of writing the class name (casing) has not always been consistent within CDISC :) let $class := ( if(upper-case($defclass)= 'FINDINGS') then 'Findings' else if (upper-case($defclass)= 'EVENTS') then 'Events' else if (upper-case($defclass)= 'INTERVENTIONS') then 'Interventions' else if (starts-with(upper-case($defclass),'TRIAL')) then 'TrialDesign' else if (ends-with(upper-case($defclass),'ABOUT')) then 'FindingsAbout' else if (starts-with(upper-case($defclass),'SPECIAL')) then 'SpecialPurpose' else if (starts-with(upper-case($defclass),'RELAT')) then 'Relationship' else 'GeneralObservations' ) (: CDISC Library query to the SDTM MODEL :) let $cdisclibraryquerysdtmmodel := concat($cdisclibrarybase,'sdtm/',$sdtmversion,'/classes/',$class) (: now run the CDISC Library query as it requires basic authentication, we need to use the EXPath 'http-client' extension :) let $cdisclibraryresponsesdtmmodel := http:send-request(, $cdisclibraryquerysdtmmodel) (: iterate over the datasets in the group - each of them has the same def:Class value :) for $itemgroupdef in $group/odm:ItemGroupDef (: get the name of the dataset and the domain :) let $name := $itemgroupdef/@Name let $domainname := $itemgroupdef/@Domain (: iterate over all variables within the dataset definition :) for $itemrefoid in $itemgroupdef/odm:ItemRef/@ItemOID let $varname := $definedoc//odm:ItemDef[@OID=$itemrefoid]/@Name (: we need to take generic variable names into account, e.g. LBDTC goes into --DTC :) let $varnamegen := ( if(starts-with($varname,$domainname)) then concat('--',substring($varname,3)) else $varname ) (: now look up the variable name in the SDTM model for this class :) let $cdisclibraryvar := ( if($class = 'Interventions' or $class='Events' or $class='Findings') then $cdisclibraryresponsesdtmmodel/json//classVariables/*[name=$varname or name=$varnamegen] else $cdisclibraryresponsesdtmmodel/json//datasetVariables/*[name=$varname or name=$varnamegen] )(: and in the "General Observations Class" :) let $cdisclibrarygeneralvar := $cdisclibrarygeneralobservationsresponse/json//classVariables/*[name=$varname or name=$varnamegen] let $varnamereport := ( if(starts-with($varname,$domainname)) then $varnamegen else $varname ) where not($cdisclibraryvar) and not($cdisclibrarygeneralvar) return Variable '{data($varnamereport)}' is not in SDTM Model version {data($sdtmversion)} ]]> Variable appearing in dataset must be in the SDTM model Only variables listed in SDTM model should appear in a dataset. New sponsor defined variables must not be added, and existing variables must not be renamed or modified 3.1 3.2 ALL , $cdisclibrarygeneralobservationsquery) (: In order to minimize the number of calls to the CDISC Library, we group all dataset definition by def:Class :) (: Order all dataset definitions per def:Class, so that we need only 1 CDISC-Library call per class :) for $itemgroupdef in $definedoc//odm:ItemGroupDef[@Name=$datasetname] let $defclass := ( if($defineversion='2.1') then $itemgroupdef/def21:Class/@Name else $itemgroupdef/@def:Class ) (: Unfortunately, the way of writing the class name (casing) has not always been consistent within CDISC :) let $class := ( if(upper-case($defclass)= 'FINDINGS') then 'Findings' else if (upper-case($defclass)= 'EVENTS') then 'Events' else if (upper-case($defclass)= 'INTERVENTIONS') then 'Interventions' else if (starts-with(upper-case($defclass),'TRIAL')) then 'TrialDesign' else if (ends-with(upper-case($defclass),'ABOUT')) then 'FindingsAbout' else if (starts-with(upper-case($defclass),'SPECIAL')) then 'SpecialPurpose' else if (starts-with(upper-case($defclass),'RELAT')) then 'Relationship' else 'GeneralObservations' ) (: CDISC Library query to the SDTM MODEL :) let $cdisclibraryquerysdtmmodel := concat($cdisclibrarybase,'sdtm/',$sdtmversion,'/classes/',$class) (: now run the CDISC Library query as it requires basic authentication, we need to use the EXPath 'http-client' extension :) let $cdisclibraryresponsesdtmmodel := http:send-request(, $cdisclibraryquerysdtmmodel) let $name := $itemgroupdef/@Name let $domainname := $itemgroupdef/@Domain (: iterate over all variables within the dataset definition :) for $itemrefoid in $itemgroupdef/odm:ItemRef/@ItemOID let $varname := $definedoc//odm:ItemDef[@OID=$itemrefoid]/@Name (: we need to take generic variable names into account, e.g. LBDTC goes into --DTC :) let $varnamegen := ( if(starts-with($varname,$domainname)) then concat('--',substring($varname,3)) else $varname ) (: now look up the variable name in the SDTM model for this class :) let $cdisclibraryvar := ( if($class = 'Interventions' or $class='Events' or $class='Findings') then $cdisclibraryresponsesdtmmodel/json//classVariables/*[name=$varname or name=$varnamegen] else $cdisclibraryresponsesdtmmodel/json//datasetVariables/*[name=$varname or name=$varnamegen] )(: and in the "General Observations Class" :) let $cdisclibrarygeneralvar := $cdisclibrarygeneralobservationsresponse/json//classVariables/*[name=$varname or name=$varnamegen] let $varnamereport := ( if(starts-with($varname,$domainname)) then $varnamegen else $varname ) where not($cdisclibraryvar) and not($cdisclibrarygeneralvar) return Variable '{data($varnamereport)}' is not in SDTM Model version {data($sdtmversion)} ]]> Permissible variable with missing value for all records is not allowed Permissible variable whould not be present in domain, when the variable has missing value for all records in the dataset 3.0 3.1 ALL , $cdisclibraryquerysendig) (: Iterate over all dataset definitions :) for $itemgroupdef in $group/odm:ItemGroupDef (: get name, domain and class :) let $name := $itemgroupdef/@Name let $domainname := ( if($itemgroupdef/@Domain) then $itemgroupdef/@Domain else if (starts-with($name,'SUPP')) then 'SUPPQUAL' else if ($name='POOLDEF') then 'POOLDEF' else if ($name='RELREC') then 'RELREC' else substring($name,1,2) ) (: get the location of the dataset and the document itself :) let $dsloc := ( if($defineversion='2.1') then $itemgroupdef/def21:leaf/@xlink:href else $itemgroupdef/def:leaf/@xlink:href ) let $doc := ( if($dsloc) then doc(concat($base,$dsloc)) else () (: no location defined :) ) (: Iterate over all the variables in the dataset definition :) for $itemoid in $itemgroupdef/odm:ItemRef/@ItemOID let $varname := $definedoc//odm:ItemDef[@OID=$itemoid]/@Name (: Get the "core" property - can be "Req", "Exp" or "Perm" :) let $core := ($cdisclibraryresponsesendig/json/datasets/*[name=$domainname]//*[./name=$varname]/core/text()) (: return {data($domainname)} - {data($varname)} - {$core} :) (: in case a variable is not explicitely mentioned in the SEND-IG), it is always permissible 'Perm' :) let $core := ( if(not($core)) then 'Perm' else $core ) (: count the number of records in the dataset for the "Perm" variables :) (: if the variable is NOT 'Perm' we set the count artficially to 1 so that the system does not need to go over all the records, which saves time :) let $count := ( if(not($core='Perm')) then 1 else count($doc//odm:ItemGroupData/odm:ItemData[@ItemOID=$itemoid and @Value]) ) where $core='Perm' and $count=0 return Permissible variable {data($varname)} with missing value for all records ]]> Permissible variable with missing value for all records is not allowed Permissible variable whould not be present in domain, when the variable has missing value for all records in the dataset 3.0 3.1 ALL , $cdisclibraryquerysendig) (: get name, domain :) let $name := $itemgroupdef/@Name let $domainname := ( if($itemgroupdef/@Domain) then $itemgroupdef/@Domain else if (starts-with($name,'SUPP')) then 'SUPPQUAL' else if ($name='POOLDEF') then 'POOLDEF' else if ($name='RELREC') then 'RELREC' else substring($name,1,2) ) (: get the location of the dataset and the document itself :) let $dsloc := ( if($defineversion='2.1') then $itemgroupdef/def21:leaf/@xlink:href else $itemgroupdef/def:leaf/@xlink:href ) let $doc := ( if($dsloc) then doc(concat($base,$dsloc)) else () (: no location defined :) ) (: Iterate over all the variables in the dataset definition :) for $itemoid in $itemgroupdef/odm:ItemRef/@ItemOID let $varname := $definedoc//odm:ItemDef[@OID=$itemoid]/@Name (: Get the "core" property - can be "Req", "Exp" or "Perm" :) let $core := ($cdisclibraryresponsesendig/json/datasets/*[name=$domainname]//*[./name=$varname]/core/text()) (: return {data($domainname)} - {data($varname)} - {$core} :) (: in case a variable is not explicitely mentioned in the SEND-IG), it is always permissible 'Perm' :) let $core := ( if(not($core)) then 'Perm' else $core ) (: count the number of records in the dataset for the "Perm" variables :) (: if the variable is NOT 'Perm' we set the count artficially to 1 so that the system does not need to go over all the records, which saves time :) let $count := ( if(not($core='Perm')) then 1 else count($doc//odm:ItemGroupData/odm:ItemData[@ItemOID=$itemoid and @Value]) ) where $core='Perm' and $count=0 return Permissible variable {data($varname)} with missing value for all records ]]> Split datasets must not have name of original domain Split datasets must not have name of original domain. E.g., lbhm.xpt is a valid name, when lb.xpt is not a valid dataset name for split domain. 3.0 3.1 INTERVENTIONS FINDINGS EVENTS 1 and not(string-length(substring-before($filename,'.')) > 2) (: filenames should have >2 characters before the dot :) return Split dataset {data($name)} has a file name '{data($filename)}' that is typical for non-split datasets ]]> RELTYPE may oly be 'ONE' or 'MANY' Relationship Type (RELTYPE) variable values should be populated with terms 'ONE', 'MANY', when Related Records (RELREC) dataset is used to identify relationships between datasets 3.0 3.1 RELREC Invalid value for RELTYPE variable: only 'ONE' or 'MANY' is allowed. The value '{data($value)}'was found ]]> Coded and Decoded values must have the same NCI Code in CDISC CT Paired variables TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value 3.0 3.1 ALL {data($testcdncivalue)} - {data($testncivalue)} :) (: if there is an NCI value for the TESTCD, then the NCI value for the TEST must be identical :) where $testcdncivalue and not($testcdncivalue=$testncivalue) return The Coded value '{data($testcdvalue)}' with NCI code '{data($testcdncivalue)}' and Decode value '{data($testvalue)}' with NCI code '{data($testcdncivalue)}' do not have the same NCI code ]]> Coded and Decoded values must have the same NCI Code in CDISC CT Paired variables TEST/TESTCD must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between paired variable values defined in CDISC control terminology by Codelist Code value 3.0 3.1.3 3.2 ALL {data($testcdncivalue)} - {data($testncivalue)} :) (: if there is an NCI value for the TESTCD, then the NCI value for the TEST must be identical :) where $testcdncivalue and not($testcdncivalue=$testncivalue) return The Coded value '{data($testcdvalue)}' with NCI code '{data($testcdncivalue)}' and Decode value '{data($testvalue)}' with NCI code '{data($testcdncivalue)}' do not have the same NCI code ]]> Values for --CAT and --SCAT may not be identical Values of Category (--CAT) and Subcategory (--SCAT) variables should not be identical 3.0 3.1 ALL {data($scatname)} value '{data($catvalue)}' is identical to {data($catname)} value '{data($scatvalue)}' ]]> Values for --CAT and --SCAT may not be identical Values of Category (--CAT) and Subcategory (--SCAT) variables should not be identical 3.0 3.1 ALL {data($scatname)} value '{data($catvalue)}' is identical to {data($catname)} value '{data($scatvalue)}' ]]> Variables marked as Required may not have a null value Required variables (where Core attribute is 'Req') cannot be NULL for any records 3.0 3.1 ALL , $cdisclibraryquerysendig) (: get name, domain :) let $name := $itemgroupdef/@Name let $domainname := ( if($itemgroupdef/@Domain) then $itemgroupdef/@Domain else if (starts-with($name,'SUPP')) then 'SUPPQUAL' else if ($name='POOLDEF') then 'POOLDEF' else if ($name='RELREC') then 'RELREC' else substring($name,1,2) ) (: get the location of the dataset and the document itself :) let $dsloc := ( if($defineversion='2.1') then $itemgroupdef/def21:leaf/@xlink:href else $itemgroupdef/def:leaf/@xlink:href ) let $doc := ( if($dsloc) then doc(concat($base,$dsloc)) else () (: no location defined :) ) (: Iterate over all the variables in the dataset definition :) for $itemoid in $itemgroupdef/odm:ItemRef/@ItemOID let $varname := $definedoc//odm:ItemDef[@OID=$itemoid]/@Name (: Get the "core" property - can be "Req", "Exp" or "Perm" :) let $core := ($cdisclibraryresponsesendig/json/datasets/*[name=$domainname]//*[./name=$varname]/core/text()) (: return {data($domainname)} - {data($varname)} - {$core} :) (: in case a variable is not explicitely mentioned in the SEND-IG), it is always permissible 'Perm' :) let $core := ( if(not($core)) then 'Perm' else $core ) (: count the number of records in the dataset for the "Perm" variables :) (: if the variable is NOT 'Perm' we set the count artficially to 1 so that the system does not need to go over all the records, which saves time :) (: get the records that have a null value and that are required :) for $record in $doc//odm:ItemGroupData[not(odm:ItemData[@ItemOID=$itemoid])][$core='Req'] let $recnum := $record/@data:ItemGroupDataSeq return Required variable {data($varname)} has a missing value ]]> Values for --SEQ variable may not be duplicate within USUBJID/POOLID The value of Sequence Number (--SEQ) variable must be unique for each record within a domain and within each Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables value when they are present in the domain 3.0 3.1 ALL 1 return The record with USUBJID = {data($usubjid)} and {data($seqname)} is not unique in the dataset {data($itemgroupname)}. The following records have the same combination of USUBJID and {data($seqname)}: records number {data($recnums)} ]]> Values for --SEQ variable may not be duplicate within USUBJID The value of Sequence Number (--SEQ) variable must be unique for each record within a domain and within each Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables value when they are present in the domain 3.0 3.1 ALL 1 return The record with USUBJID = {data($usubjid)} and {data($seqname)} is not unique in the dataset {data($itemgroupname)}. The following records have the same combination of USUBJID and {data($seqname)}: records number {data($recnums)} ]]> Values for --SEQ variable may not be duplicate within POOLID The value of Sequence Number (--SEQ) variable must be unique for each record within a domain and within each Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables value when they are present in the domain 3.0 3.1 ALL 1 return The record with POOLID = {data($poolid)} and {data($seqname)} is not unique in the dataset {data($itemgroupname)}. The following records have the same combination of POOLID and {data($seqname)}: records number {data($recnums)} ]]> Subject must be present in DM domain All Subjects (USUBJID) must be present in Demographics (DM) domain 3.0 3.1 ALL USUBJID {data($value)} in dataset {data($datasetname)} could not be found in DM dataset ]]> Subject must be present in DM domain All Subjects (USUBJID) must be present in Demographics (DM) domain 3.0 3.1 ALL USUBJID {data($value)} in dataset {data($datasetname)} could not be found in DM dataset ]]> --ENTPT variable must be present, when --ENRTPT variable is present End Reference Time Point (--ENTPT) variable must be included into the domain, when End Relative to Reference Time Point (--ENRTPT) variable is present 3.0 3.1 INTERVENTIONS EVENTS FINDINGS SE Missing {data($entptname)} variable, when {data($enrtptname)} variable is present ]]> --ENRTPT variable must be present, when --ENTPT variable is present End Reference to Reference Time Point (--ENRTPT) variable must be included into the domain, when End Relative Time Point (--ENTPT) variable is present 3.0 3.1 ALL Missing {data($enrtptname)} variable, when {data($entptname)} variable is present ]]> --STRTPT variable must be present, when --STTPT variable is present Start Relative to Reference Time Point (--STRTPT) variable must be included into the domain, when Start Relative Time Point (--STTPT) variable is present 3.0 3.1 INTERVENTIONS EVENTS FINDINGS SE CG0060 {data($strtptname)} is not present although {data($sttptname)} is present ]]> --STTPT variable must be present, when --STRTPT variable is present Start Reference Time Point (--STTPT) variable must be included into the domain, when Start Relative to Reference Time Point (--STRTPT) variable is present 3.0 3.1 INTERVENTIONS EVENTS FINDINGS SE CG0061 {data($sttptname)} is not present although {data($strtptname)} is present ]]> --CAT value may not be redundant with other variable values Value of Category (--CAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS) 3.0 3.1 INTERVENTIONS EVENTS FINDINGS TI The value of {data($catname)} is redundant. It is equal to one of DOMAIN, --TERM, --TESTCD, --TRT, --BODSYS ]]> --CAT value may not be redundant with other variable values Value of Category (--CAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS) 3.0 3.1 INTERVENTIONS EVENTS FINDINGS TI The value of {data($catname)} is redundant. It is equal to one of DOMAIN, --TERM, --TESTCD, --TRT, --BODSYS ]]> Value for --TPT must be provided, when --TPTNUM is provided Planned Time Point Name (--TPT) should not be NULL, when Planned Time Point Number (--TPTNUM) is populated 3.0 3.1 INTERVENTIONS EVENTS FINDINGS CO Variable {data($tptname)} is not populated although variable {data($tptnumname)} is populated, value={data($tptnum)} ]]> Value for --TPT must be provided, when --TPTNUM is provided Planned Time Point Name (--TPT) should not be NULL, when Planned Time Point Number (--TPTNUM) is populated 3.0 3.1 INTERVENTIONS EVENTS FINDINGS CO Variable {data($tptname)} is not populated although variable {data($tptnumname)} is populated, value={data($tptnum)} ]]> --STAT must be populated, when --REASND is populated Completion Status (--STAT) should be set to 'NOT DONE', when Reason Not Done (--REASND) is populated 3.0 3.1 ALL Missing or invalid value for {data($statname)} when {data($reasndname)} is provided - {data($reasndname)}={data($reasndvalue)} - {data($statname)}={data($statvalue)} in dataset {data($datasetname)} ]]> --STAT must be populated, when --REASND is populated Completion Status (--STAT) should be set to 'NOT DONE', when Reason Not Done (--REASND) is populated 3.0 3.1 ALL Missing or invalid value for {data($statname)} when {data($reasndname)} is provided - {data($reasndname)}={data($reasndvalue)} - {data($statname)}={data($statvalue)} in dataset {data($datasetname)} ]]> Only one of Dose (--DOSE) or Dose Description (--DOSTXT) variables must be populated on the same record Only one of Dose (--DOSE) or Dose Description (--DOSTXT) variables must be populated on the same record 3.0 3.1 INTERVENTIONS CG0110 Both {data($dosename)} and {data($dostxtname)} are populated ]]> Only one of Dose (--DOSE) or Dose Description (--DOSTXT) variables must be populated on the same record Only one of Dose (--DOSE) or Dose Description (--DOSTXT) variables must be populated on the same record 3.0 3.1 INTERVENTIONS CG0110 Both {data($dosename)} and {data($dostxtname)} are populated ]]> When --DOSE != null or --DOSTOT != null or --DOSTXT != null then --DOSU may not be null Dose Units (--DOSU) must be populated, when Dose per Administration (--DOSE), Dose Description (--DOSTXT) or Total Daily Dose (--DOSTOT) is provided 3.0 3.1 INTERVENTIONS CG0114 {data($dosuname)} is not populated although one of {data($dosename)}, {data($dostxtname)} or {data($dostotname)} is populated ]]> When --DOSE != null or --DOSTOT != null or --DOSTXT != null then --DOSU must be != null Dose Units (--DOSU) must be populated, when Dose per Administration (--DOSE), Dose Description (--DOSTXT) or Total Daily Dose (--DOSTOT) is provided 3.0 3.1 INTERVENTIONS CG0114 {data($dosuname)} is not populated although one of {data($dosename)}, {data($dostxtname)} or {data($dostotname)} is populated ]]> Screen failure subjects, if submitted, must be in DM, with ARMCD = 'SCRNFAIL' and ARM = 'Screen Failure' The combination of Description of Planned Arm (ARM) and Planned Arm Code (ARMCD) values must match entries in the Trial Arms (TA) dataset, except for subjects who failed screening (ARMCD = 'SCRNFAIL') or were not fully assigned to an Arm (ARMCD = 'NOTASSGN') 3.0 3.1 DM CG0128 Invalid value for ARMCD, value='{data($armcdvalue)}' is not found in TA and is not one of('SCRNFAIL', 'NOTASSGN') ]]> Subjects withdrawn before arm assignment, if not screen failures, must have ARMCD ='NOTASSGN' and ARM = 'Not Assigned' in DM Subjects withdrawn from a trial before assignment to an Arm, if they are not screen failures, should have ARMCD ='NOTASSGN' and ARM = 'Not Assigned' 3.0 3.1 DM CG0128 Invalid value for ARM, value='{data($armvalue)}' is not found in TA and is not one of('Screen Failure', 'Not Assigned') ]]> When ARMCD not in ('SCRNFAIL', 'NOTASSGN') then ARMCD must be in TA.ARMCD Planned Arm Code (ARMCD) values should match entries in the Trial Arms (TA) dataset, except for subjects who failed screening (ARMCD = 'SCRNFAIL') or were not fully assigned to an Arm (ARMCD = 'NOTASSGN') 3.0 3.1 DM CG0126 Invalid value for ARMCD, value={data($armcdvalue)} in dataset DM is not one of ('SCRNFAIL', 'NOTASSGN') and is not found in TA.ARMCD ]]> RFENDTC must be populated, unless ARMCD = 'SCRNFAIL' or ARMCD = 'NOTASSGN' Subject Reference End Date/Time (RFENDTC) must be populated for all randomized subjects, that have Planned Arm Code (ARMCD) not equal to 'SCRNFAIL' or 'NOTASSGN' 3.0 3.1 DM CG0142 RFENDTC=null for ACTARM='{data($actarmvalue)}'. RFENDTC is required to be populated for all randomized subjects. ]]> RFSTDTC must be populated for all subjects, those where ARMCD is not equal to 'SCRNFAIL' or 'NOTASSGN' Subject Reference Start Date/Time (RFSTDTC) should be populated for all randomized subjects, those where Planned Arm Code (ARMCD) is not equal to 'SCRNFAIL' or 'NOTASSGN' 3.0 3.1 DM CG0146 RFSTDTC expected to be not null for ACTARM='{data($actarmvalue)}' ]]> The value of Set Code (SETCD) may not be more than 8 characters in length The value of Set Code (SETCD) should be no more than 8 characters in length 3.0 3.1 DM CG0149 8 return SETCD='{data($setcdvalue)}' has more than 8 characters ]]> SUBJID must be unique for each subject in the study The value of Subject Identifier for the Study (SUBJID) variable must be unique for each subject within the study - DM 3.0 3.1 DM FDAC048 $recnum][odm:ItemData[@ItemOID=$subjidoid][@Value=$subjidvalue]]) where $count > 0 return Duplicate value of SUBJID={data($subjidvalue)} - {data($count)} in dataset {data($datasetname)} ]]> USUBJID must be unique for each subject The value of Unique Subject Identifier (USUBJID) variable must be unique for each subject across all trials in the submission 3.0 3.1 DM FDAC048 $recnum][odm:ItemData[@ItemOID=$usubjidoid][@Value=$usubjidvalue]]) where $count > 0 return Duplicate value of SUBJID={data($usubjidvalue)} - {data($count)} in dataset {data($datasetname)} ]]> When ETCD = 'UNPLAN' then ELEMENT must be null Description of Element (ELEMENT) should be NULL, when subject's experience for a particular period of time is represented as an unplanned Element, where Element Code (ETCD) is equal to 'UNPLAN' 3.0 3.1 SE CG0152 Invalid value for ELEMENT={data($element)}, null was expected for ETCD='UNPLAN' ]]> ARMCD may be no more than 20 characters The value of Planned Arm Code (ARMCD) should be no more than 20 characters in length 3.0 3.1 DM TA TV CG0153 20 return Invalid value for ARMCD={data($armcdvalue)} in dataset {data($datasetname)} - it has more than 20 characters ]]> ELEMENT must be unique for a given ETCD Description of Element (ELEMENT) must have a unique value for a given value of Element Code (ETCD) within the domain 3.0 3.1 SE TA CG0154 $recnum][odm:ItemData[@ItemOID=$etcdoid] and odm:ItemData[@ItemOID=$elementoid] and odm:ItemData[@ItemOID=$etcdoid]/@Value=$etcdvalue] let $recnum2 := $record2/@data:ItemGroupDataSeq (: and again, get the values of ETCD and ELEMENT :) let $etcdvalue2 := $record2/odm:ItemData[@ItemOID=$etcdoid]/@Value (: should be identical to $etcdvalue :) let $elementvalue2 := $record2/odm:ItemData[@ItemOID=$elementoid]/@Value (: ELEMENT must be equal to ELEMENT of the the earlier record :) where not($elementvalue=$elementvalue2) return Non-unique combination for ELEMENT and ETCD. Record {data($recnum)} has ETCD='{data($etcdvalue)}' and and ELEMENT='{data($elementvalue)}' whereas record {data($recnum2)} has ETCD='{data($etcdvalue2)}' and has ELEMENT='{data($elementvalue2)}' in dataset {data($name)} ]]> RDOMAIN must be populated when IDVAR is populated Value of Related Domain Abbreviation (RDOMAIN) variable must be populated, when value of Identifying Variable (IDVAR) variable is populated 3.0 3.1 CO CG0166 IDVARVAL={data($idvarval)} but RDOMAIN=null ]]> CODTC must be NULL when RDOMAIN, IDVAR and IDVARVAL are populated The value of Date/Time of Comment (CODTC) should be NULL, when comments are related to a specific parent record or group of parent records in a domain (RDOMAIN, IDVAR and IDVARVAL are populated) 3.0 3.1 CO CG0168 IDVAR={data($idvar)} but a value for CODTC={data($codtc)} was found ]]> MB dataset must be included, when an MS dataset is present Microbiology Specimen (MB) dataset should be included, when a Microbiology Susceptibility Test (MS) dataset is present 3.0 3.1 MB MS Document {data($mbdatasetname)} for domain MB could not be found in collection {data($base)} although document {data($msdatasetname)} is present ]]> IDVARVAL value may not be populated, when RELTYPE values is populated Variable Value (IDVARVAL) variable value should not be populated, when Relationship Type (RELTYPE) variable value is populated 3.0 3.1 RELREC IDVARVAL value is populated (value={data($idvarvalvalue)}, when RELTYPE values is populated (value={data($reltypevalue)}) ]]> USUBJID value may not be populated, when RELTYPE values is populated Unique Subject Identifier (USUBJID) variable value should not be populated, when Relationship Type (RELTYPE) variable value is populated in RELREC 3.0 3.1 RELREC USUBJID value is populated (value={data($usubjidvalue)}), when RELTYPE values is populated (value={data($reltypevalue)}) in dataset {data($relrecdatasetname)} ]]> IDVAR and IDVARVAL may not populated for DM supplemental qualifiers Both Identifying Variable (IDVAR) and Identifying Variable Value (IDVARVAL) should not be populated, when relating information to the Demographics (DM) domain 3.0 3.1 SUPPQUAL Unexpected value for IDVAR/IDVARVAL: IDVAR and/or IDVARVAL are populated although RDOMAIN=DM in dataset {data($datasetname)} ]]> IDVAR value must be provided, when RDOMAIN value is provided Value of Identifying Variable (IDVAR) variable must be populated, when Related Domain Abbreviation (RDOMAIN) variable value is provided, with the only exception of 'DM' value for RDOMAIN 3.0 3.1 RELREC SUPPQUAL Missing IDVAR value, when RDOMAIN value is provided, RDOMAIN={data($rdomainvalue)} ]]> TAETORD may not be populated, when ETCD = 'UNPLAN' Planned Order of Elements within Arm (TAETORD) should be NULL, when subject's experience for a particular period of time is represented as an unplanned Element (ETCD = 'UNPLAN') 3.0 3.1 SE 0 return TAETORD is populated, value={data($taetordvalue)} with ETCD='UNPLAN' in dataset SE ]]> When ETCD='UNPLAN', SEUPDES may not be null 3.0 3.1 SE CG0211 Missing value for SEUPDES, when ETCD='UNPLAN' ]]> --STDY variable value must be populated when --STDTC and DM.RFSTDTC are provided Study Day of Start (--STDY) variable value should be populated, when Start Study Date (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both of them include complete date part 3.0 3.1 INTERVENTIONS EVENTS FINDINGS SE SV = 10 (: boolean :) (: get the USUBJID and get the corresponding RFSTDTC in the DM dataset :) let $usubjidvalue := $record/odm:ItemData[@ItemOID=$usubjidoid]/@Value (: keeping the worst case scenario into account that there is more than 1 record for a USUBJID in DM - take the first :) let $rfstdtcvalue := doc($dmdatasetlocation)//odm:ItemGroupData[odm:ItemData[@ItemOID=$dmusubjidoid and @Value=$usubjidvalue]][1]/odm:ItemData[@ItemOID=$rfstdtcoid]/@Value (: and check whether RFSTDTC is a complete date :) let $iscompleterfstdtcdate := string-length($rfstdtcvalue) >= 10 (: Get the value of the STDY variable (if any) :) let $stdyvalue := $record/odm:ItemData[@ItemOID=$stdyoid]/@Value (: STDY MUST be populated when the variable is in the dataset and when both RFSTDTC AND STDTC are complete dates :) where $stdyoid and $iscompletestdtcdate and $iscompleterfstdtcdate and not($stdyvalue) return {data($stdyname)} variable is not populated although both {data($stdtcname)} (value={data($stdtcvalue)}) and RFSTDTC (value={data($rfstdtcvalue)}) are complete dates ]]> --STDY variable value must be populated when --STDTC and DM.RFSTDTC are provided Study Day of Start (--STDY) variable value should be populated, when Start Study Date (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both of them include complete date part 3.0 3.1 INTERVENTIONS EVENTS FINDINGS SE SV = 10 (: boolean :) (: get the USUBJID and get the corresponding RFSTDTC in the DM dataset :) let $usubjidvalue := $record/odm:ItemData[@ItemOID=$usubjidoid]/@Value (: keeping the worst case scenario into account that there is more than 1 record for a USUBJID in DM - take the first :) let $rfstdtcvalue := doc($dmdatasetlocation)//odm:ItemGroupData[odm:ItemData[@ItemOID=$dmusubjidoid and @Value=$usubjidvalue]][1]/odm:ItemData[@ItemOID=$rfstdtcoid]/@Value (: and check whether RFSTDTC is a complete date :) let $iscompleterfstdtcdate := string-length($rfstdtcvalue) >= 10 (: Get the value of the STDY variable (if any) :) let $stdyvalue := $record/odm:ItemData[@ItemOID=$stdyoid]/@Value (: STDY MUST be populated when the variable is in the dataset and when both RFSTDTC AND STDTC are complete dates :) where $stdyoid and $iscompletestdtcdate and $iscompleterfstdtcdate and not($stdyvalue) return {data($stdyname)} variable is not populated although both {data($stdtcname)} (value={data($stdtcvalue)}) and RFSTDTC (value={data($rfstdtcvalue)}) are complete dates ]]> --STDY must be correctly calculated Study Day of Start (--STDY) variable value should be populated as defined by CDISC standards: --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) +1 if --STDTC is on or after RFSTDTC; --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) if --STDTC precedes RFSTDTC 3.0 3.1 INTERVENTIONS EVENTS FINDINGS SE = 10 (: boolean :) (: look up the record in the DM dataset and get the RFSTDTC :) (: taking the worst case scenario into account that there is more than one record for a USUBJID in DM - take the first one :) let $rfstdtcvalue := doc($dmdatasetlocation)//odm:ItemGroupData[odm:ItemData[@ItemOID=$dmusubjidoid and @Value=$usubjidvalue]][1]/odm:ItemData[@ItemOID=$rfstdtcoid]/@Value (: and check whether also RFSTDTC is complete :) let $iscompleterfstdtcvalue := string-length($rfstdtcvalue) >= 10 (: boolean :) let $stdyvalue := $record/odm:ItemData[@ItemOID=$stdyoid]/@Value (: now calculate the DY value but only when RFSTDTC and STDTC have a complete date part :) let $stdycalculated := ( if ($iscompleterfstdtcvalue and $iscompletestdtcvalue) then (: if there is one, we must strip off the time part :) let $stdtcvalueshort := substring($stdtcvalue,1,10) let $rfstdtcvalueshort := substring($rfstdtcvalue,1,10) let $stdycalc := ( if($stdtcvalueshort castable as xs:date and $rfstdtcvalueshort castable as xs:date) then days-from-duration(xs:date($stdtcvalueshort)-xs:date($rfstdtcvalueshort)) else() ) return $stdycalc else () (: one or both dates are not complete dates :) ) (: for the FDA there is no day 0, DY can only be <0 or >0, first day is day 1 :) let $stdycalculatedfda := ( if($stdycalculated >= 0) then $stdycalculated + 1 else ( $stdycalculated ) ) (: before comparing, also check whether the value is really an integer :) where $stdyvalue castable as xs:integer and $stdycalculatedfda and $stdyvalue and not($stdycalculatedfda = $stdyvalue) return Invalid value for {data($stdyname)}, calculated value={data($stdycalculatedfda)}, observed value={data($stdyvalue)}, in dataset {data($name)} ]]> --STDY must be correctly calculated Study Day of Start (--STDY) variable value should be populated as defined by CDISC standards: --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) +1 if --STDTC is on or after RFSTDTC; --STDY = (date portion of --STDTC) - (date portion of RFSTDTC) if --STDTC precedes RFSTDTC 3.0 3.1 INTERVENTIONS EVENTS FINDINGS SE = 10 (: boolean :) (: look up the record in the DM dataset and get the RFSTDTC :) (: taking the worst case scenario into account that there is more than one record for a USUBJID in DM - take the first one :) let $rfstdtcvalue := doc($dmdatasetlocation)//odm:ItemGroupData[odm:ItemData[@ItemOID=$dmusubjidoid and @Value=$usubjidvalue]][1]/odm:ItemData[@ItemOID=$rfstdtcoid]/@Value (: and check whether also RFSTDTC is complete :) let $iscompleterfstdtcvalue := string-length($rfstdtcvalue) >= 10 (: boolean :) let $stdyvalue := $record/odm:ItemData[@ItemOID=$stdyoid]/@Value (: now calculate the DY value but only when RFSTDTC and STDTC have a complete date part :) let $stdycalculated := ( if ($iscompleterfstdtcvalue and $iscompletestdtcvalue) then (: if there is one, we must strip off the time part :) let $stdtcvalueshort := substring($stdtcvalue,1,10) let $rfstdtcvalueshort := substring($rfstdtcvalue,1,10) let $stdycalc := ( if($stdtcvalueshort castable as xs:date and $rfstdtcvalueshort castable as xs:date) then days-from-duration(xs:date($stdtcvalueshort)-xs:date($rfstdtcvalueshort)) else() ) return $stdycalc else () (: one or both dates are not complete dates :) ) (: for the FDA there is no day 0, DY can only be <0 or >0, first day is day 1 :) let $stdycalculatedfda := ( if($stdycalculated >= 0) then $stdycalculated + 1 else ( $stdycalculated ) ) (: before comparing, also check whether the value is really an integer :) where $stdyvalue castable as xs:integer and $stdycalculatedfda and $stdyvalue and not($stdycalculatedfda = $stdyvalue) return Invalid value for {data($stdyname)}, calculated value={data($stdycalculatedfda)}, observed value={data($stdyvalue)}, in dataset {data($name)} ]]> STDY variable value may not be imputed Study Day of Start (--STDY) variable value may not be imputed. It may be only populated, when both Start Study Date/Time (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both of them include complete date part. 3.0 3.1 INTERVENTIONS EVENTS FINDINGS SE = 10 (: boolean :) (: get the USUBJID and get the corresponding RFSTDTC in the DM dataset :) let $usubjidvalue := $record/odm:ItemData[@ItemOID=$usubjidoid]/@Value (: taking the worst case scenario into account that there is more than one record for a USUBJID in DM - take the first one :) let $rfstdtcvalue := doc($dmdatasetlocation)//odm:ItemGroupData[odm:ItemData[@ItemOID=$dmusubjidoid and @Value=$usubjidvalue]][1]/odm:ItemData[@ItemOID=$rfstdtcoid]/@Value (: and check whether RFSTDTC is a complete date :) let $iscompleterfstdtcdate := string-length($rfstdtcvalue) >= 10 (: Get the value of the STDY variable (if any) :) let $stdyvalue := $record/odm:ItemData[@ItemOID=$stdyoid]/@Value (: STDY may NOT be populated when of RFSTDTC or STDTC is an incomplete date :) where $stdyoid and (not($iscompletestdtcdate) or not($iscompleterfstdtcdate)) and $stdyvalue return {data($stdyname)} variable value {data($stdyvalue)} is imputed although one of {data($stdtcname)} (value={data($stdtcvalue)}) or RFSTDTC (value={data($rfstdtcvalue)}) is not a complete date ]]> STDY variable value may not be imputed Study Day of Start (--STDY) variable value may not be imputed. It may be only populated, when both Start Study Date/Time (--STDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both of them include complete date part. 3.0 3.1 INTERVENTIONS EVENTS FINDINGS SE = 10 (: boolean :) (: get the USUBJID and get the corresponding RFSTDTC in the DM dataset :) let $usubjidvalue := $record/odm:ItemData[@ItemOID=$usubjidoid]/@Value (: taking the worst case scenario into account that there is more than one record for a USUBJID in DM - take the first one :) let $rfstdtcvalue := doc($dmdatasetlocation)//odm:ItemGroupData[odm:ItemData[@ItemOID=$dmusubjidoid and @Value=$usubjidvalue]][1]/odm:ItemData[@ItemOID=$rfstdtcoid]/@Value (: and check whether RFSTDTC is a complete date :) let $iscompleterfstdtcdate := string-length($rfstdtcvalue) >= 10 (: Get the value of the STDY variable (if any) :) let $stdyvalue := $record/odm:ItemData[@ItemOID=$stdyoid]/@Value (: STDY may NOT be populated when of RFSTDTC or STDTC is an incomplete date :) where $stdyoid and (not($iscompletestdtcdate) or not($iscompleterfstdtcdate)) and $stdyvalue return {data($stdyname)} variable value {data($stdyvalue)} is imputed although one of {data($stdtcname)} (value={data($stdtcvalue)}) or RFSTDTC (value={data($rfstdtcvalue)}) is not a complete date ]]> --ENDY variable value must be populated when --ENDTC and DM.RFSTDTC are provided Study Day of End (--ENDY) variable value should be populated, when End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both of them include complete date part 3.0 3.1 INTERVENTIONS EVENTS FINDINGS SE = 10 (: boolean :) (: get the USUBJID and get the corresponding RFSTDTC in the DM dataset :) let $usubjidvalue := $record/odm:ItemData[@ItemOID=$usubjidoid]/@Value (: taking the worst case scenario into account that there is more than 1 record for a USUBJID in DM - take the first one :) let $rfstdtcvalue := doc($dmdatasetlocation)//odm:ItemGroupData[odm:ItemData[@ItemOID=$dmusubjidoid and @Value=$usubjidvalue]][1]/odm:ItemData[@ItemOID=$rfstdtcoid]/@Value (: and check whether RFSTDTC is a complete date :) let $iscompleterfstdtcdate := string-length($rfstdtcvalue) >= 10 (: Get the value of the STDY variable (if any) :) let $endyvalue := $record/odm:ItemData[@ItemOID=$endyoid]/@Value (: ENDY MUST be populated when the variable is in the dataset and when both ENSTDTC AND ENDTC are complete dates :) where $endyoid and $iscompleteendtcdate and $iscompleterfstdtcdate and not($endyvalue) return {data($endyname)} variable is not populated although both {data($endtcname)} (value={data($endtcvalue)}) and RFSTDTC (value={data($rfstdtcvalue)}) are complete dates ]]> --ENDY variable value must be populated when --ENDTC and DM.RFSTDTC are provided Study Day of End (--ENDY) variable value should be populated, when End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both of them include complete date part 3.0 3.1 INTERVENTIONS EVENTS FINDINGS SE = 10 (: boolean :) (: get the USUBJID and get the corresponding RFSTDTC in the DM dataset :) let $usubjidvalue := $record/odm:ItemData[@ItemOID=$usubjidoid]/@Value (: taking the worst case scenario into account that there is more than 1 record for a USUBJID in DM - take the first one :) let $rfstdtcvalue := doc($dmdatasetlocation)//odm:ItemGroupData[odm:ItemData[@ItemOID=$dmusubjidoid and @Value=$usubjidvalue]][1]/odm:ItemData[@ItemOID=$rfstdtcoid]/@Value (: and check whether RFSTDTC is a complete date :) let $iscompleterfstdtcdate := string-length($rfstdtcvalue) >= 10 (: Get the value of the STDY variable (if any) :) let $endyvalue := $record/odm:ItemData[@ItemOID=$endyoid]/@Value (: ENDY MUST be populated when the variable is in the dataset and when both ENSTDTC AND ENDTC are complete dates :) where $endyoid and $iscompleteendtcdate and $iscompleterfstdtcdate and not($endyvalue) return {data($endyname)} variable is not populated although both {data($endtcname)} (value={data($endtcvalue)}) and RFSTDTC (value={data($rfstdtcvalue)}) are complete dates ]]> --ENDY must be correctly calculated Study Day of End (--ENDY) variable value should be populated as defined by CDISC standards: --ENDY = (date portion of --STDTC) - (date portion of RFSTDTC) +1 if --ENDTC is on or after RFSTDTC; --ENTDY = (date portion of --ENDTC) - (date portion of RFSTDTC) if --ENDTC precedes RFSTDTC 3.0 3.1 INTERVENTIONS EVENTS FINDINGS SE SV = 10 (: boolean :) (: look up the record in the DM dataset and get the RFSTDTC :) (: taking worst case scenario into account that there is more than 1 record for a USUBJID in DM - take the first one :) let $rfstdtcvalue := doc($dmdatasetlocation)//odm:ItemGroupData[odm:ItemData[@ItemOID=$dmusubjidoid and @Value=$usubjidvalue]][1]/odm:ItemData[@ItemOID=$rfstdtcoid]/@Value (: and check whether also RFSTDTC is complete :) let $iscompleterfstdtcvalue := string-length($rfstdtcvalue) >= 10 (: boolean :) let $endyvalue := $record/odm:ItemData[@ItemOID=$endyoid]/@Value (: now calculate the DY value but only when RFSTDTC and ENDTC have a complete date part :) let $endycalculated := ( if ($iscompleterfstdtcvalue and $iscompletestdtcvalue) then (: if there is one, we must strip off the time part :) let $endtcvalueshort := substring($endtcvalue,1,10) let $rfstdtcvalueshort := substring($rfstdtcvalue,1,10) let $endycalc := ( if($endtcvalueshort castable as xs:date and $rfstdtcvalueshort castable as xs:date) then days-from-duration(xs:date($endtcvalueshort)-xs:date($rfstdtcvalueshort)) else() ) return $endycalc else () (: one or both dates are not complete dates :) ) (: for the FDA there is no day 0, DY can only be <0 or >0, first day is day 1 :) let $endycalculatedfda := ( if($endycalculated >= 0) then $endycalculated + 1 else ( $endycalculated ) ) (: before comparing, check that the ENDY value is really an integer :) where $endyvalue castable as xs:integer and $endycalculatedfda and $endyvalue and not($endycalculatedfda = $endyvalue) return Invalid value for {data($endyname)}, calculated value={data($endycalculatedfda)}, observed value={data($endyvalue)}, in dataset {data($datasetname)} ]]> --ENDY must be correctly calculated Study Day of End (--ENDY) variable value should be populated as defined by CDISC standards: --ENDY = (date portion of --STDTC) - (date portion of RFSTDTC) +1 if --ENDTC is on or after RFSTDTC; --ENTDY = (date portion of --ENDTC) - (date portion of RFSTDTC) if --ENDTC precedes RFSTDTC 3.0 3.1 INTERVENTIONS EVENTS FINDINGS SE SV = 10 (: boolean :) (: look up the record in the DM dataset and get the RFSTDTC :) (: taking worst case scenario into account that there is more than 1 record for a USUBJID in DM - take the first one :) let $rfstdtcvalue := doc($dmdatasetlocation)//odm:ItemGroupData[odm:ItemData[@ItemOID=$dmusubjidoid and @Value=$usubjidvalue]][1]/odm:ItemData[@ItemOID=$rfstdtcoid]/@Value (: and check whether also RFSTDTC is complete :) let $iscompleterfstdtcvalue := string-length($rfstdtcvalue) >= 10 (: boolean :) let $endyvalue := $record/odm:ItemData[@ItemOID=$endyoid]/@Value (: now calculate the DY value but only when RFSTDTC and ENDTC have a complete date part :) let $endycalculated := ( if ($iscompleterfstdtcvalue and $iscompletestdtcvalue) then (: if there is one, we must strip off the time part :) let $endtcvalueshort := substring($endtcvalue,1,10) let $rfstdtcvalueshort := substring($rfstdtcvalue,1,10) let $endycalc := ( if($endtcvalueshort castable as xs:date and $rfstdtcvalueshort castable as xs:date) then days-from-duration(xs:date($endtcvalueshort)-xs:date($rfstdtcvalueshort)) else() ) return $endycalc else () (: one or both dates are not complete dates :) ) (: for the FDA there is no day 0, DY can only be <0 or >0, first day is day 1 :) let $endycalculatedfda := ( if($endycalculated >= 0) then $endycalculated + 1 else ( $endycalculated ) ) (: before comparing, check that the ENDY value is really an integer :) where $endyvalue castable as xs:integer and $endycalculatedfda and $endyvalue and not($endycalculatedfda = $endyvalue) return Invalid value for {data($endyname)}, calculated value={data($endycalculatedfda)}, observed value={data($endyvalue)}, in dataset {data($datasetname)} ]]> --ENDY variable value may not be imputed Study Day of End (--ENDY) variable value should be not be imputed. It may be only populated, when both End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both of them include complete date part 3.0 3.1 INTERVENTIONS EVENTS FINDINGS SE SV = 10 (: boolean :) (: get the USUBJID and get the corresponding RFSTDTC in the DM dataset :) let $usubjidvalue := $record/odm:ItemData[@ItemOID=$usubjidoid]/@Value (: taking worst case scenario into account that there is more than 1 record for a USUBJID in DM - take the first one :) let $rfstdtcvalue := doc($dmdatasetlocation)//odm:ItemGroupData[odm:ItemData[@ItemOID=$dmusubjidoid and @Value=$usubjidvalue]][1]/odm:ItemData[@ItemOID=$rfstdtcoid]/@Value (: and check whether RFSTDTC is a complete date :) let $iscompleterfstdtcdate := string-length($rfstdtcvalue) >= 10 (: Get the value of the STDY variable (if any) :) let $endyvalue := $record/odm:ItemData[@ItemOID=$endyoid]/@Value (: ENDY may NOT be populated when of RFSTDTC or ENDTC is an incomplete date :) where $endyoid and (not($iscompletestdtcdate) or not($iscompleterfstdtcdate)) and $endyvalue return {data($endyname)} variable value {data($endyvalue)} is imputed although one of {data($endtcname)} (value={data($endtcvalue)}) or RFSTDTC (value={data($rfstdtcvalue)}) is not a complete date ]]> --ENDY variable value may not be imputed Study Day of End (--ENDY) variable value should be not be imputed. It may be only populated, when both End Study Date/Time (--ENDTC) and Subject Reference Start Date/Time (RFSTDTC) variables values are provided, and both of them include complete date part 3.0 3.1 INTERVENTIONS EVENTS FINDINGS SE SV = 10 (: boolean :) (: get the USUBJID and get the corresponding RFSTDTC in the DM dataset :) let $usubjidvalue := $record/odm:ItemData[@ItemOID=$usubjidoid]/@Value (: taking worst case scenario into account that there is more than 1 record for a USUBJID in DM - take the first one :) let $rfstdtcvalue := doc($dmdatasetlocation)//odm:ItemGroupData[odm:ItemData[@ItemOID=$dmusubjidoid and @Value=$usubjidvalue]][1]/odm:ItemData[@ItemOID=$rfstdtcoid]/@Value (: and check whether RFSTDTC is a complete date :) let $iscompleterfstdtcdate := string-length($rfstdtcvalue) >= 10 (: Get the value of the STDY variable (if any) :) let $endyvalue := $record/odm:ItemData[@ItemOID=$endyoid]/@Value (: ENDY may NOT be populated when of RFSTDTC or ENDTC is an incomplete date :) where $endyoid and (not($iscompletestdtcdate) or not($iscompleterfstdtcdate)) and $endyvalue return {data($endyname)} variable value {data($endyvalue)} is imputed although one of {data($endtcname)} (value={data($endtcvalue)}) or RFSTDTC (value={data($rfstdtcvalue)}) is not a complete date ]]> Value for --STRF may not be populated, when RFSTDTC is NULL Start Relative to Reference Period (--STRF) should not be populated for subjects with missing value for Reference Start Date/Time (RFSTDTC) 3.1 INTERVENTIONS EVENTS FINDINGS SE SV Value for {data($strfname)} is populated(value={data($strfvalue)}), when RFSTDTC is NULL in dataset {data($datasetname)} ]]> Value for --STRF may not be populated, when RFSTDTC is NULL Start Relative to Reference Period (--STRF) should not be populated for subjects with missing value for Reference Start Date/Time (RFSTDTC) 3.1 INTERVENTIONS EVENTS FINDINGS SE SV Value for {data($strfname)} is populated(value={data($strfvalue)}), when RFSTDTC is NULL in dataset {data($datasetname)} ]]> Value for --ENRF may not be populated, when RFSTDTC is NULL End Relative to Reference Period (--ENRF) should not be populated for subjects with missing value for Reference End Date/Time (RFENDTC) 3.1 INTERVENTIONS EVENTS FINDINGS SE SV Value for {data($enrfname)} is populated(value={data($enrfvalue)}), when RFENDTC is NULL in dataset {data($name)} ]]> Value for --ENRF may not be populated, when RFENDTC is NULL End Relative to Reference Period (--ENRF) should not be populated for subjects with missing value for Reference End Date/Time (RFENDTC) 3.1 INTERVENTIONS EVENTS FINDINGS SE SV Value for {data($enrfname)} is populated(value={data($enrfvalue)}), when RFENDTC is NULL in dataset {data($name)} ]]> Value of *DTC variable must be a valid ISO 8601 date/datime value Value of Dates/Time variables (*DTC) must conform to the ISO 8601 date/datetime international standard 3.0 3.1 ALL invalid ISO-8601 value for variable {data($itemname)} value = {data($value)} in dataset {data($itemgroupdefname)} ]]> Value of *DTC variable must be a valid ISO 8601 date/datime value Value of Dates/Time variables (*DTC) must conform to the ISO 8601 date/datetime international standard 3.0 3.1 ALL Invalid ISO-8601 value for variable {data($itemname)} value = {data($value)} in dataset {data($itemgroupdefname)} ]]> Value for --TPT must be consistent within --TPTNUM All values of Planned Time Point Name (--TPT) variable should be the same for a given value of Planned Time Point Number (--TPTNUM) variable 3.0 3.1 INTERVENTIONS EVENTS FINDINGS Inconsistent value for {data($tptname)} within {data($tptnumname)} in dataset {data($datasetname)}. {data($uniquetptvaluescount)} different {data($tptname)} values were found for {data($tptnumname)}={data($tptnumuniquevalue)} ]]> Value for --TPT must be consistent within --TPTNUM All values of Planned Time Point Name (--TPT) variable should be the same for a given value of Planned Time Point Number (--TPTNUM) variable 3.0 3.1 INTERVENTIONS EVENTS FINDINGS Inconsistent value for {data($tptname)} within {data($tptnumname)} in dataset {data($datasetname)}. {data($uniquetptvaluescount)} different {data($tptname)} values were found for {data($tptnumname)}={data($tptnumuniquevalue)} ]]> Value for --TPTNUM must be consistent within --TPT All values of Planned Time Point Number (--TPTNUM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable 3.0 3.1 INTERVENTIONS FINDING EVENTS Inconsistent value for {data($tptnumname)} within {data($tptname)} in dataset {data($datasetname)}. {data($uniquetptnumvaluescount)} different {data($tptnumname)} values were found for {data($tptname)}={data($tptuniquevalue)} ]]> Value for --TPTNUM must be consistent within --TPT All values of Planned Time Point Number (--TPTNUM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable 3.0 3.1 INTERVENTIONS FINDING EVENTS Inconsistent value for {data($tptnumname)} within {data($tptname)} in dataset {data($datasetname)}. {data($uniquetptnumvaluescount)} different {data($tptnumname)} values were found for {data($tptname)}={data($tptuniquevalue)} ]]> Value for --TPT must be consistent within --ELTM All values of Planned Elapsed Time (--ELTM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable 3.0 3.1 INTERVENTIONS EVENTS FINDINGS 0 and not($uniqueeltmvaluescount = 1) return Inconsistent value for {data($eltmname)} within {data($tptname)} in dataset {data($datasetname)}. {data($uniqueeltmvaluescount)} different {data($eltmname)} values were found for {data($tptname)}={data($tptuniquevalue)} ]]> Value for --TPT must be consistent within --ELTM All values of Planned Elapsed Time (--ELTM) variable should be the same for a given value of Planned Time Point Name (--TPT) variable 3.0 3.1 INTERVENTIONS EVENTS FINDINGS 0 and not($uniqueeltmvaluescount = 1) return Inconsistent value for {data($eltmname)} within {data($tptname)} in dataset {data($datasetname)}. {data($uniqueeltmvaluescount)} different {data($eltmname)} values were found for {data($tptname)}={data($tptuniquevalue)} ]]> The value of Element Code (ETCD) may not be more than 8 characters in length The value of Element Code (ETCD) may not be more than 8 characters in length 3.0 3.1 SE 8 return Invalid value for ETCD in SE dataset {data($sedatasetname)} - Value {data($etcdvalue)} has more than 8 characters ]]> TAETORD must be unique within ARMCD Order of Element within Arm (TAETORD) must have a unique value for a given value of Planned Arm Code (ARMCD) within the domain 3.0 3.1 TA $recnum] let $recnumnext := $nextrecord/@data:ItemGroupDataSeq (: and look for duplicate values :) let $taarmcdvaluenext := $nextrecord/odm:ItemData[@ItemOID=$taarmcdoid]/@Value let $tataetordvaluenext := $nextrecord/odm:ItemData[@ItemOID=$tataetordoid]/@Value where $taarmcdvalue = $taarmcdvaluenext and $tataetordvalue = $tataetordvaluenext return Non-unique value for TAETORD within ARMCD. Records {data($recnum)} and {data($recnumnext)} have the same value for ARMCD={data($taarmcdvalue)} and TAETORD={data($tataetordvalue)} in TA dataset {data($tadatasetname)} ]]> Value for --PARMCD variable may not be longer than 8 characters The value of Parameter Short Name (--PARMCD) variables should be no more than 8 characters in length 3.0 3.1 TS 8 return The value for TSPARMCD in dataset {data($datasetname)} has more than 8 characters: '{data($testvalue)}' was found ]]> The value in TSPARM may not be longer than 40 characters The value of Parameter (--PARM) variable should be no more than 40 characters in length 3.0 3.1 TS 40 characters. The rule is a relict of the ancient XPT format. :) xquery version "3.0"; declare namespace def = "http://www.cdisc.org/ns/def/v2.0"; declare namespace def21 = "http://www.cdisc.org/ns/def/v2.1"; declare namespace odm="http://www.cdisc.org/ns/odm/v1.3"; declare namespace data="http://www.cdisc.org/ns/Dataset-XML/v1.0"; declare namespace xlink="http://www.w3.org/1999/xlink"; declare namespace xs="http://www.w3.org/2001/XMLSchema"; declare namespace functx = "http://www.functx.com"; (: "declare variable ... external" allows to pass $base and $define from an external programm :) declare variable $base external; declare variable $define external; declare variable $defineversion external; (: let $base := '/db/fda_submissions/cdisc01/' :) (: let $define := 'define2-0-0-example-sdtm.xml' :) let $definedoc := doc(concat($base,$define)) (: iterate over all TS datasets (there should be only one) :) for $itemgroup in $definedoc//odm:ItemGroupDef[@Name='TS'] (: Get the OID for the TSPARM variable :) let $testoid := ( for $a in $definedoc//odm:ItemDef[@Name='TSPARM']/@OID where $a = $definedoc//odm:ItemGroupDef[@Name='TS']/odm:ItemRef/@ItemOID return $a ) (: we of course only look into datasets where there really is a --TEST :) let $datasetname := ( if($defineversion='2.1') then $itemgroup//def21:leaf/@xlink:href else $itemgroup//def:leaf/@xlink:href ) let $datasetdoc := ( if($datasetname) then doc(concat($base,$datasetname)) else () ) (: iterate over all the records within the TS dataset :) for $record in $datasetdoc//odm:ItemGroupData (: get the record number :) let $recnum := $record/@data:ItemGroupDataSeq (: and get the value of the TSPARM variable :) let $testvalue := $record/odm:ItemData[@ItemOID=$testoid]/@Value (: when it has more than 40 characters, give an error :) where string-length($testvalue) > 40 return The value for TSPARM in dataset {data($datasetname)} has more than 40 characters: '{data($testvalue)}' was found ]]> TSVALNF must be populated when TSVAL is missing Value for Parameter Null Flavor (TSVALNF) variable must be populated, when Parameter Value (TSVAL) variable value is missing 3.1 TS Missing TSVALNF value ]]> TSVAL may only be null when TSVALNF is populated Value for Parameter Value (TSVAL) variable must be populated. TSVAL can only be null when Parameter Null Flavor (TSVALNF) variable value is populated 3.1 TS Missing TSVAL value ]]> TSSEQ variable value must be unique within TSPARMCD The value of Sequence Number (--SEQ) variable must be unique for each record within a domain and within each Unique Subject Identifier (USUBJID) or Pool Identifier (POOLID) variables value when they are present in the domain 3.0 3.1 TS $recnum] :) let $count := count($tsdatasetdoc//odm:ItemGroupData[odm:ItemData[@ItemOID=$tsseq and @Value=$seqvalue] and odm:ItemData[@ItemOID=$tsparmcd and @Value=$parmcdvalue]]) where $count > 1 return Non-unique value for TSSEQ variable within TSPARMCD - combination of TSSEQ={data($seqvalue)} and TSPARMCD={data($parmcdvalue)} occurs {data($count)} times ]]> Value for --PARM must be consistent within --PARMCD All values of a Parameter (--PARM) variables should be the same for a given value of a Parameter Short Name (--PARMCD) variables - TS domain 3.0 3.1 TS $recnum][odm:ItemData[@ItemOID=$tsparmcdoid and @Value=$tsparmcdvalue1]] let $recnum2 := $record2/@data:ItemGroupDataSeq (: let $tsparmcdvalue2 := $record/odm:ItemData[@ItemOID=$tsparmcdoid]/@Value :) let $tsparmvalue2 := $record2/odm:ItemData[@ItemOID=$tsparmoid]/@Value (: and compare the values - both must be equal :) where not($tsparmvalue1=$tsparmvalue2) return Inconsistent value for --PARM within --PARMCD: both records {data($recnum)} and {data($recnum2)} have --PARMCD='{data($tsparmcdvalue1)}' but the values for --PARM '{data($tsparmvalue1)}' and '{data($tsparmvalue2)}' are different ]]> Value for --PARMCD must be consistent within --PARM All values of a Parameter Short Name (--PARMCD) variables should be the same for a given value of a Parameter (--PARM) variables 3.0 3.1 TS $recnum][odm:ItemData[@ItemOID=$tsparmoid and @Value=$tsparmvalue1]] let $recnum2 := $record2/@data:ItemGroupDataSeq let $tsparmcdvalue2 := $record2/odm:ItemData[@ItemOID=$tsparmcdoid]/@Value (: and compare the values - both must be equal :) where not($tsparmcdvalue1=$tsparmcdvalue2) return Inconsistent value for --PARMCD within --PARM: both records {data($recnum)} and {data($recnum2)} have --PARM='{data($tsparmvalue1)}' but the values for --PARMCD '{data($tsparmcdvalue1)}' and '{data($tsparmcdvalue2)}' are different ]]> RDOMAIN must correspond to a domain defined in the submission Related Domain Abbreviation (RDOMAIN) must have a valid value of Domains included in the study data 3.0 3.1 CO RELREC SUPPQUAL Invalid value for RDOMAIN='{data($rdomainvalue)}' in dataset {data($datasetname)} - domain {data($rdomainvalue)} was not found in the define.xml file {data($define)} ]]> DOMAIN value length must be 2, except for AP, RELREC The value of DOMAIN should be no more than 2 characters in length, excluding Associated Persons domains 3.0 3.1 ALL CG0308 The value for DOMAIN in the dataset does not consist of exactly 2 characters: DOMAIN='{data($domainvalue)}' was found ]]> DOMAIN value length must be 2, except for AP, RELREC The value of DOMAIN should be no more than 2 characters in length, excluding Associated Persons domains ALL 3.0 3.1 CG0308 The value for DOMAIN in the dataset does not consist of exactly 2 characters: DOMAIN='{data($domainvalue)}' was found ]]> Either one of USUBJID or POOLID must be populated Either Unique Subject Identifier (Missing or redundant values for USUBJID and POOLIDUSUBJID) or Pool Identifier (POOLID) variables values and only one must be populated 3.0 3.1 INTERVENTIONS EVENTS FINDINGS 0 and string-length($usubjid) > 0) then Both USUBJID and POOLID in dataset {data($name)} are populated (: case that neither USUBJID nor POOLID are populated :) else if (not($usubjid) and not($poolid)) then Both USUBJID and POOLID in dataset {data($name)} are populated else () ) (: return the dynamically generated message (which can be null) :) return $message ]]> Either one of USUBJID or POOLID must be populated Either Unique Subject Identifier (Missing or redundant values for USUBJID and POOLIDUSUBJID) or Pool Identifier (POOLID) variables values and only one must be populated 3.0 3.1 INTERVENTIONS EVENTS FINDINGS 0 and string-length($usubjid) > 0) then Both USUBJID and POOLID in dataset {data($name)} are populated (: case that neither USUBJID nor POOLID are populated :) else if (not($usubjid) and not($poolid)) then Both USUBJID and POOLID in dataset {data($name)} are populated else () ) (: return the dynamically generated message (which can be null) :) return $message ]]> At least one of TEENRL or TEDUR must be populated At least one of Rule for End of Element (TEENRL) or Planned Duration of Element (TEDUR) should be populated in TE 3.0 3.1 TE Missing values for TEENRL and TEDUR ]]> Variable must be ordered in the domain as by CDISC Standards Order of variables should be as specified by CDISC standard 3.0 3.1 ALL , $identifierstimingsquery) (: we need to split identifiers and timing variable :) let $identifiers := $identifierstimingsresponse/json//classVariables/*[role='Identifier']/name/text() let $timings := $identifierstimingsresponse/json//classVariables/*[role='Timing']/name/text() (: Use the CDISC Library to get all Interventions variables :) let $interventionsquery := concat($cdisclibrarybase,'Interventions') let $interventionsresponse := http:send-request(, $interventionsquery) let $interventions := $interventionsresponse/json//classVariables/*/name/text() (: Use the CDISC Library to get all Events variables :) let $eventsquery := concat($cdisclibrarybase,'Events') let $eventsresponse := http:send-request(, $eventsquery) let $events := $eventsresponse/json//classVariables/*/name/text() (: Use the CDISC Library to get all Events variables :) let $findingsquery := concat($cdisclibrarybase,'Findings') let $findingsesponse := http:send-request(, $findingsquery) let $findings := $findingsesponse/json//classVariables/*/name/text() (: Use the CDISC Library to get all FindingsAbout variables :) let $findingsaboutquery := concat($cdisclibrarybase,'FindingsAbout') let $findingsaboutresponse := http:send-request(, $findingsaboutquery) let $findingsabout := $findingsaboutresponse/json//classVariables/*/name/text() (: Use the CDISC Library to get all SpecialPurpose variables :) (: ATTENTION: these are organized per dataset! :) let $specialpurposequery := concat($cdisclibrarybase,'SpecialPurpose') let $specialpurposeresponse := http:send-request(, $specialpurposequery) let $specialpurpose := $specialpurposeresponse/json//datasets (: Use the CDISC Library to get all TrialDesign variables :) (: ATTENTION: these are organized per dataset! :) let $trialdesignquery := concat($cdisclibrarybase,'TrialDesign') let $trialdesignresponse := http:send-request(, $trialdesignquery) (: Remark that we do NOT go into the individual datasets YET :) let $trialdesign := $trialdesignresponse/json//datasets (: Use the CDISC Library to get all TrialDesign variables :) (: ATTENTION: these are organized per dataset! :) let $relastionshipquery := concat($cdisclibrarybase,'Relationship') let $relationshipresponse := http:send-request(, $relastionshipquery) let $relationship := $relationshipresponse/json//datasets (: Use the CDISC Library to get all AssociatedPersons variables :) let $associatedpersonsquery := concat($cdisclibrarybase,'AssociatedPersons') let $associatedpersonsresponse := http:send-request(, $associatedpersonsquery) let $associatedpersonsclassVariables := $associatedpersonsresponse/json//classVariables/*/name/text() let $associatedpersonsdatasetVariables := $associatedpersonsresponse/json//datasetVariables/*/name/text() (: iterate over all dataset definitions, and get the class, name and domain :) for $itemgroupdef in $definedoc//odm:ItemGroupDef let $defclass := ( if($defineversion='2.1') then $itemgroupdef/def21:Class/@Name else $itemgroupdef/@def:Class ) let $name := $itemgroupdef/@Name let $domain := ( if(starts-with($name,'SUPP')) then 'SUPPQUAL' else if($itemgroupdef/@Domain) then $itemgroupdef/@Domain else if($itemgroupdef/@Name='RELREC') then 'RELREC' else substring($itemgroupdef/@Name,1,2) ) (: get the variable name :) let $variables := ( for $varoid in $itemgroupdef/odm:ItemRef/@ItemOID return $definedoc//odm:ItemDef[@OID=$varoid]/@Name ) (: now comes the different part: check the order :) (: depending on the class, create an ordered array of the variables that are applicable :) (: Read the def:Class, if incorrect, set cdisclibraryclass to 'UNKNOWN' :) let $cdisclibraryclass := ( if(upper-case($defclass)='INTERVENTIONS') then 'Interventions' else if (upper-case($defclass)='EVENTS') then 'Events' else if (upper-case($defclass)='FINDINGS') then 'Findings' else if (upper-case($defclass)='FINDINGS ABOUT' or upper-case($defclass)='FINDINGSABOUT') then 'FindingsAbout' else if (upper-case($defclass)='SPECIAL PURPOSE' or upper-case($defclass)='SPECIALPURPOSE') then 'SpecialPurpose' else if (upper-case($defclass)='TRIALDESIGN' or upper-case($defclass)='TRIAL DESIGN') then 'TrialDesign' else if (upper-case($defclass)='RELATIONSHIP') then 'Relationship' else 'UNRECOGNIZED' ) (: P.S. FINDINGS ABOUT is NOT in SEND :) let $orderedvariables := ( if($cdisclibraryclass = 'Interventions') then functx:value-union(functx:value-union($identifiers,$interventions),$timings) else if($cdisclibraryclass = 'Events') then functx:value-union(functx:value-union($identifiers,$events),$timings) else if($cdisclibraryclass = 'Findings') then functx:value-union(functx:value-union($identifiers,$findings),$timings) else if($cdisclibraryclass = 'TrialDesign') then $trialdesign/*[./name=$domain]/datasetVariables/*/name else if(upper-case($defclass)='Relationship') then $relationship/*[./name=$domain]/datasetVariables/*/name else if($cdisclibraryclass = 'SpecialPurpose') then $specialpurpose/*[./name=$domain]/datasetVariables/*/name else () ) (: we need to replace '--' by the domain name :) let $orderedvars := local:replacedash($orderedvariables,$domain) (: check whether the variables from the define.xml is a subset of the list of domain variables :) let $issubset := local:compare($orderedvars,$variables) where not($issubset) return Variable order is not correct for class '{$cdisclibraryclass}': found = {data($variables)} - expected = {$orderedvars} ]]> SCAT may not have the same value as DOMAIN, -TERM, -TESTCD, -TRT or -BODSYS Value of Subcategory (--SCAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS) 3.0 3.1 INTERVENTIONS EVENTS FINDINGS TI Redundancy in paired variables values for {data($scatname)} with value={data($scatvalue)}. ]]> SCAT may not have the same value as DOMAIN, -TERM, -TESTCD, -TRT or BODSYS Value of Subcategory (--SCAT) should not be identical to that in Domain Abbreviation (DOMAIN); Reported Term (--TERM); Name of Measurement, Test, or Examination (--TESTCD); Name of Treatment (--TRT); Body System or Organ Class (--BODSYS) 3.0 3.1 INTERVENTIONS EVENTS FINDINGS TI Redundancy in paired variables values for {data($scatname)} with value={data($scatvalue)}. ]]> --ORRES must be provided, when --ORRESU is provided Result or Finding in Original Units (--ORRES) should not be NULL, when Original Units (--ORRESU) is provided 3.0 3.1 FINDINGS Missing value for {data($orresname)}, when {data($orresuname)}, value={data($orresuvalue)} is provided in dataset {data($datasetname)} ]]> --ORRES must be provided, when --ORRESU is provided Result or Finding in Original Units (--ORRES) should not be NULL, when Original Units (--ORRESU) is provided 3.0 3.1 FINDINGS Missing value for {data($orresname)}, when {data($orresuname)}, value={data($orresuvalue)} is provided in dataset {data($datasetname)} ]]> --ORRES must be populated, when --STAT or --DRVFL is not populated Status (--STAT) should be set to 'NOT DONE' or Derived Flag (--DRVFL) should have a value of 'Y', when Result or Finding in Original Units (--ORRES) is NULL 3.0 3.1 FINDINGS Status {data($statname)} should be set to 'NOT DONE' or Derived Flag {data($drvflname)} should have a value of 'Y', when Result or Finding in Original Units {data($orresname)} is NULL ]]> --ORRES must be populated, when --STAT or --DRVFL is not populated Status (--STAT) should be set to 'NOT DONE' or Derived Flag (--DRVFL) should have a value of 'Y', when Result or Finding in Original Units (--ORRES) is NULL 3.0 3.1 FINDINGS Status {data($statname)} should be set to 'NOT DONE' or Derived Flag {data($drvflname)} should have a value of 'Y', when Result or Finding in Original Units {data($orresname)} is NULL ]]> When --DRVFL = 'Y' then --STRESC must be populated Character Result/Finding in Std Format (--STRESC) value should not be NULL, when Derived Flag (--DRVFL) value is 'Y' 3.0 3.1 FINDINGS Value of {data($strescname)} may not be null when {data($drvflname)}='Y' ]]> When --DRVFL = 'Y' then --STRESC must be populated Character Result/Finding in Std Format (--STRESC) value should not be NULL, when Derived Flag (--DRVFL) value is 'Y' 3.0 3.1 FINDINGS Value of {data($strescname)} may not be null when {data($drvflname)}='Y' ]]> IDVAR must be a valid variable name of the referenced domain Identifying Variable (IDVAR) must have a valid value of variables from a referenced Domain 3.0 3.1 RELREC SUPPQUAL CO Variable '{data($idvarvalue)}' was not found in the parent dataset of the referenced domain RDOMAIN='{data($rdomain)}' ]]> Referenced record must be an existing record Reference record defined by Related Domain Abbreviation (RDOMAIN), Unique Subject Identifier (USUBJID), Identifying Variable (IDVAR) and Identifying Variable Value (IDVARVAL) must exist in the target Domain 3.0 3.1 CO RELREC SUPPQUAL Invalid referenced record - Dataset={data($name)}: no parent records found in RDOMAIN={data($rdomainval)} for USUBJID={data($usubjidvalue)} ]]> Value for --TESTCD variable may not be longer than 8 characters The value of a Short Name of Measurement, Test or Examination (--TESTCD) variable should be limited to 8 characters, cannot start with a number, and cannot contain characters other than letters in upper case, numbers, or underscores 3.0 3.1 FINDINGS 8 or functx:is-value-in-sequence($firstchar,$numbers) or not(matches($value,'[A-Z_][A-Z0-9_]*')) return Invalid value for Short Name of Measurement, Test or Examination (--TESTCD) variable: it should be limited to 8 characters, cannot start with a number, and cannot contain characters other than letters in upper case, numbers, or underscores. Value '{data($value)}' was found for variable {data($testname)} in dataset {data($datasetname)}. ]]> Value for --TESTCD variable may not be longer than 8 characters The value of a Short Name of Measurement, Test or Examination (--TESTCD) variable should be limited to 8 characters, cannot start with a number, and cannot contain characters other than letters in upper case, numbers, or underscores 3.0 3.1 FINDINGS 8 or functx:is-value-in-sequence($firstchar,$numbers) or not(matches($value,'[A-Z_][A-Z0-9_]*')) return Invalid value for Short Name of Measurement, Test or Examination (--TESTCD) variable: it should be limited to 8 characters, cannot start with a number, and cannot contain characters other than letters in upper case, numbers, or underscores. Value '{data($value)}' was found for variable {data($testname)} in dataset {data($datasetname)}. ]]> --STRESC must be provided, when --ORRES is provided Character Result/Finding in Std Units (--STRESC) must be populated, when Result or Finding in Original Units (--ORRES) is provided 3.0 3.1 FINDINGS FDAC171 Missing value for {data($strescname)}, when {data($orresname)} is provided, {data($orresname)}='{data($orresvalue)}' is provided in dataset {data($datasetname)} ]]> --STRESC must be provided, when --ORRES is provided Character Result/Finding in Std Units (--STRESC) must be populated, when Result or Finding in Original Units (--ORRES) is provided 3.0 3.1 FINDINGS FDAC171 Missing value for {data($strescname)}, when {data($orresname)} is provided, {data($orresname)}='{data($orresvalue)}' is provided in dataset {data($datasetname)} ]]> The value of --TEST may not be more than 40 characters The value of Name of Measurement, Test or Examination (--TEST) should be no more than 40 characters in length 3.0 3.1 FINDINGS 40 characters. The rule is a relict of the ancient XPT format. ALSO:IETEST is an exception: may be up to 200 characters :) xquery version "3.0"; declare namespace def = "http://www.cdisc.org/ns/def/v2.0"; declare namespace def21 = "http://www.cdisc.org/ns/def/v2.1"; declare namespace odm="http://www.cdisc.org/ns/odm/v1.3"; declare namespace data="http://www.cdisc.org/ns/Dataset-XML/v1.0"; declare namespace xlink="http://www.w3.org/1999/xlink"; declare namespace xs="http://www.w3.org/2001/XMLSchema"; declare namespace functx = "http://www.functx.com"; (: "declare variable ... external" allows to pass $base and $define from an external programm :) declare variable $base external; declare variable $define external; declare variable $defineversion external; (: let $base := '/db/fda_submissions/cdisc01/' :) (: let $define := 'define2-0-0-example-sdtm.xml' :) let $definedoc := doc(concat($base,$define)) (: iterate over all datasets and variables in the define.xml :) for $itemgroup in $definedoc//odm:ItemGroupDef let $itemgroupdefname := $itemgroup/@Name (: Get the @Domain value when present, otherwise the @Name value - this is for allowing 'splitted' domains, e.g. @Name=QSCG @Domain=QS :) let $datasetname := $itemgroup/@Name let $domain := ( if($itemgroup/@Domain != '') then $itemgroup/@Domain else $itemgroup/@Name ) (: The --TEST variable is the concatenation of the domain code and 'TEST' :) let $testvar := concat($domain,'TEST') (: Get the OID for the --TEST variable :) let $testoid := ( for $a in $definedoc//odm:ItemDef[@Name=$testvar]/@OID where $a = $definedoc//odm:ItemGroupDef[@Name=$datasetname]/odm:ItemRef/@ItemOID return $a ) (: we of course only look into datasets where there really is a --TEST :) let $datasetname := ( if($defineversion='2.1') then $itemgroup//def21:leaf/@xlink:href else $itemgroup//def:leaf/@xlink:href ) let $dataset := concat($base,$datasetname) (: iterate over all the records where there is a --TEST variable :) for $record in doc($dataset)//odm:ItemGroupData (: get the record number :) let $recnum := $record/@data:ItemGroupDataSeq (: and get the value of the --TEST variable :) let $testvalue := $record/odm:ItemData[@ItemOID=$testoid]/@Value (: when it has more than 40 characters, give an error. Attention: IETEST is an exception (may be up to 200 characters) :) where string-length($testvalue) > 40 and not($testvar='IETEST') return The value for {data($testvar)} has more than 40 characters: '{data($testvalue)}' was found ]]> Domain tables must have at least one record Domain table should have at least one record 3.0 3.1 ALL {$numrecords} found in dataset: {data($datasetname)} ]]> Domain tables must have at least one record Domain table should have at least one record 3.0 3.1 ALL {$numrecords} found in dataset: {data($datasetname)} ]]> Study Identifier (STUDYID) values must match the STUDYID in Demographics (DM) domain Study Identifier (STUDYID) values must match the STUDYID in Demographics (DM) domain 3.0 3.1 ALL STUDYID {data($d/@Value)} in dataset {data($dataset)} does not match the STUDYID {data($dmstudyid)} in the DM dataset ]]> VISITNUM must be unique for each subject in SV The value of Visit Number (VISITNUM) variable should be unique for each record within a subject - Dataset SV 3.1.2 3.1.3 3.2 SV 1 return Non-unique combination of USUBID and VISITNUM in dataset SV - combination of USUBJID={data($usubjidvalue)} and VISITNUM={data($visitnumvalue)} occurrs {data($count)} times ]]> There may be only one record per IDVAR, IDVARVAL, and QNAM value per subject All SUPPQUAL Domains records are associated with a single parent record and must have a unique combination of Study Identifier (STUDYID), Unique Subject Identifier (USUBJID), Identifying Variable (IDVAR), Identifying Variable Value (IDVARVAL) and Qualifier Variable Name (QNAM) variable value. For all SUPPQUAL domain record all The QNAM variable should be unique for each parent record 3.0 3.1 SUPPQUAL CG0411 1 return The combination of USUBJID={data($usubjidvalue)}, IDVAR={data($idvar)}, IDVARVAL={data($idvarval)} and QNAM={data($qnam)} is not unique ]]> Every treated subject must have at least one DS record All Demographics (DM) subjects (USUBJID) should have at least one record in the Disposition (DS) domain with only possible exceptions to Screen Failures (ARMCD='SCRNFAIL') and Not Assigned Treatment (ARMCD='NOTASSGN') subjects 3.0 3.1 DS DM No disposition records were found in dataset {data($dsdatasetname)} for subject {data($usubjidvalue)} with assigned arm {data($arm)} ]]> Value for DOMAIN variable must be consistent Domain Abbreviation (DOMAIN) variable should be consistent with the name of the dataset 3.0 3.1 ALL 1 return Inconsistent Domain Abbreviation (DOMAIN) variable value in dataset {data($datasetname)}. Following values were found: {data($distinctdomainvalues)} ]]> Value for DOMAIN variable must be consistent Domain Abbreviation (DOMAIN) variable should be consistent with the name of the dataset 3.0 3.1 ALL 1 return Inconsistent Domain Abbreviation (DOMAIN) variable value in dataset {data($datasetname)}. Following values were found: {data($distinctdomainvalues)} ]]> ETCD values must be registered in TA except for unplanned Element Code (ETCD) values should match entries in the Trial Elements (TE) dataset, except for unplanned Element (ETCD = 'UNPLAN') 3.0 3.1 SE TA Invalid ETCD: Element Code ETCD={data($etcdvalue)} in dataset {data($datasetlocation)} was not found in TE dataset {data($tedatasetlocation)} ]]> ETCD/ELEMENT combinations must match entries in TE The combination of Element Code (ETCD) and Description of Element (ELEMENT) values should match entries in the Trial Elements (TE) dataset, except for unplanned Element (ETCD = 'UNPLAN') - dataset SE,TA 3.0 3.1 SE TA Invalid ETCD/ELEMENT in dataset {data($datasetname)}. The combination of Element Code ETCD={data($etcdvalue)} and Description of Element ELEMENT={data($elementvalue)} was not found in the TE dataset {data($tedatasetname)} ]]> QLABEL may not have more than 40 characters Qualifier Variable Label (QLABEL) value may have up to 40 characters 3.0 3.1 ALL 40 return Invalid value for QLABEL in dataset {data($datasetname)} - Label={data($qlabelvalue)} has more than 40 characters ]]> QNAM may not have more than 8 characters The value of Qualifier Variable Name (QNAM) should be limited to 8 characters, cannot start with a number, and cannot contain characters other than letters in upper case, numbers, or underscores 3.0 3.1 SUPPQUAL 8 or not(matches($qnamvalue,'[A-Z_][A-Z0-9_]*')) return Invalid value for QNAM in dataset {data($datasetname)} - Label={data($qnamvalue)} has more than 8 characters or starts with a number or contains characters other than letters in upper case, numbers, or underscores ]]> TAETORD must be registered in TA Order of Element within Arm (TAETORD) values for all datasets should match entries in the Trial Arms (TA) dataset 3.0 3.1 INTERVENTIONS EVENTS FINDINGS CO SE Invalid TAETORD in {data($name)} in dataset {data($datasetname)}. TAETORD={data($taetord)} was not found in dataset {data($tadatasetname)} ]]> TAETORD must be registered in TA - Order of Element within Arm (TAETORD) values for all datasets should match entries in the Trial Arms (TA) dataset Order of Element within Arm (TAETORD) values for all datasets should match entries in the Trial Arms (TA) dataset 3.0 3.1 INTERVENTIONS EVENTS FINDINGS CO SE Invalid TAETORD in {data($name)} in dataset {data($datasetname)}. TAETORD={data($taetord)} was not found in dataset {data($tadatasetname)} ]]> RELTYPE must be null when IDVAR is populated with a --SEQ Relationship Type (RELTYPE) in RELREC must be NULL, when Identifying Variable (IDVAR) is populated with a --SEQ value 3.0 3.1 RELREC 0 return Invalid value for RELTYPE variable. Non-null value={data($relvalue)} was found though identifying variable is {data($idvarvalue)} ]]> --STRF Time point for non-occurred event or intervention may not be provided Value of Start Relative to Reference Period (--STRF) should not be populated, when an event or intervention is marked as not occurred 3.1 INTERVENTIONS EVENTS Value of Start Relative to Reference Period ({data($strfname)} should not be populated for non-occurred event or intervation is provided, with value of {data($occurname)}={data($occurvalue)} ]]> --STRF Time point for non-occurred event or intervention may not be provided Value of Start Relative to Reference Period (--STRF) should not be populated, when an event or intervention is marked as not occurred 3.1 INTERVENTIONS EVENTS Value of Start Relative to Reference Period ({data($strfname)} should not be populated for non-occurred event or intervation is provided, with value of {data($occurname)}={data($occurvalue)} ]]> --ENRF Time point for non-occurred event or intervention may not be provided Value of End Relative to Reference Period (--ENRF) should not be populated, when an event or intervention is marked as not occurred 3.1 INTERVENTIONS EVENTS Value of End Relative to Reference Period ({data($enrfname)} should not be populated for non-occurred event or intervation is provided, with value of {data($occurname)}={data($occurvalue)} ]]> --ENRF Time point for non-occurred event or intervention may not be provided Value of End Relative to Reference Period (--ENRF) should not be populated, when an event or intervention is marked as not occurred 3.1 INTERVENTIONS EVENTS Value of End Relative to Reference Period ({data($enrfname)} should not be populated for non-occurred event or intervation is provided, with value of {data($occurname)}={data($occurvalue)} ]]> --TRTV must be populated, when --VAMT is not NULL Treatment Vehicle (--TRTV) should be provided, when Treatment Vehicle Amount (--VAMT) is specified 3.0 3.1 INTERVENTIONS Missing value for {data($trtvname)}, when {data($vamtname)} is not NULL ]]> --TRTV must be populated, when --VAMT is not NULL Treatment Vehicle (--TRTV) should be provided, when Treatment Vehicle Amount (--VAMT) is specified 3.0 3.1 INTERVENTIONS Missing value for {data($trtvname)}, when {data($vamtname)} is not NULL ]]> --STRESC must be populated, when --STRESU is provided Character Result/Finding in Std Units (--STRESC) should not be NULL, when Standard Units (--STRESU) is provided 3.0 3.1 FINDINGS Missing value for {data($strescname)}, when {data($stresuname)} is provided, value={data($stresuvalue)} is provided in dataset {data($datasetname)} ]]> --STRESC must be populated, when --STRESU is provided Character Result/Finding in Std Units (--STRESC) should not be NULL, when Standard Units (--STRESU) is provided 3.0 3.1 FINDINGS Missing value for {data($strescname)}, when {data($stresuname)} is provided, value={data($stresuvalue)} is provided in dataset {data($datasetname)} ]]> --STRESC must be populated, when --RESCAT is populated Character Result/Finding in Std Units (--STRESC) should be provided, when Result Category (--RESCAT) is specified 3.0 3.1 FINDINGS Missing {data($strescname)}, when {data($rescatname)} value={data($rescatvalue)} is provided in dataset {data($datasetname)} ]]> --STRESC must be populated, when --RESCAT is populated Character Result/Finding in Std Units (--STRESC) should be provided, when Result Category (--RESCAT) is specified 3.0 3.1 FINDINGS Missing {data($strescname)}, when {data($rescatname)} value={data($rescatvalue)} is provided in dataset {data($datasetname)} ]]> --CAT value must be populated, when --SCAT value is populated Value for Category (--CAT) variable should be populated, when value for Subcategory (--SCAT) variable is populated 3.0 3.1 INTERVENTIONS EVENTS FINDINGS Missing {data($catname)} value, when {data($scatname)} value is populated ]]> --CAT value must be populated, when --SCAT value is populated Value for Category (--CAT) variable should be populated, when value for Subcategory (--SCAT) variable is populated 3.0 3.1 INTERVENTIONS EVENTS FINDINGS Missing {data($catname)} value, when {data($scatname)} value is populated ]]> --CAT variable must be present, when --SCAT variable is present Category (--CAT) variable should be included into dataset, when Subcategory (--SCAT) variable is present 3.0 3.1 INTERVENTIONS EVENTS FINDINGS Missing {data($catname)} variable, when {data($scatname)} variable is present ]]> AGEU must be populated, when AGE or AGETXT is populated Age Units (AGEU) variable values must be provided, when Age (AGE) or Age Range (AGETXT) variables values are populated 3.0 3.1 DM CG0432 AGEU=null, although AGE or AGETXT is populated ]]> One of AGE or AGETXT must be populated, when AGEU is provided Either of Age (AGE) or Age Range (AGETXT) variable values should be provided, when Age Units (AGEU) are populated 3.0 3.1 DM Missing values for both AGE and AGETXT, when AGEU is provided ]]> Value for --TPTNUM must be provided, when value for --TPT is provided Planned Time Point Number (--TPTNUM) variable must be included into the domain, when Planned Time Point Name (--TPT) variable is present 3.0 3.1 ALL Planned Time Point Number {data($tptnumname)} may not be NULL, when Planned Time Point Name {data($tptname)} is populated, value = {data($tptvalue)} ]]> Value for --TPTNUM must be provided, when value for --TPT is provided Planned Time Point Number (--TPTNUM) variable must be included into the domain, when Planned Time Point Name (--TPT) variable is present 3.0 3.1 ALL Planned Time Point Number {data($tptnumname)} may not be NULL, when Planned Time Point Name {data($tptname)} is populated, value = {data($tptvalue)} ]]> --TPTNUM variable must be present, when --TPT variable is present Planned Time Point Number (--TPTNUM) variable must be included into the domain, when Planned Time Point Name (--TPT) variable is present 3.1.2 3.1.3 3.2 ALL CG0468 Variable {data($tptname)} is present in dataset {data($name)} but {data($tptnumname)} is not present in the dataset ]]>