http://xml4pharmaserver.com/XML4PharmaWiki/ 2026-04-21T11:13:16+02:00 http://xml4pharmaserver.com/XML4PharmaWiki/ http://xml4pharmaserver.com/XML4PharmaWiki/lib/tpl/dokuwiki/images/favicon.ico text/html 2013-12-21T09:19:53+02:00 http://xml4pharmaserver.com/XML4PharmaWiki/doku.php?id=annotating_odm_with_sdtm_and_cdash_information&rev=1387613993&do=diff Annotating ODM with SDTM and CDASH information When designing a study, it is very useful to already include information that can later be used for submission of the clinical data to the FDA. The ODM standard does have several features for allowing to do so. text/html 2013-12-21T09:19:53+02:00 http://xml4pharmaserver.com/XML4PharmaWiki/doku.php?id=cdisc_odm_in_multi-language_studies&rev=1387613993&do=diff --- Jozef Aerts 2008/12/31 11:36 Internationalization in ODM Author: Jozef Aerts, XML4Pharma Applicable to: ODM version 1.3 Introduction Version ODM 1.3 has a good number of new features for supporting internationalization (i18n) and localization (L10n) in multi-language studies. In the study design part, labels and descriptions can be added in different languages at all levels of the study design. This for example enables to generate eCRFs on the fly in the different languages that the stu… text/html 2013-12-21T09:19:53+02:00 http://xml4pharmaserver.com/XML4PharmaWiki/doku.php?id=clinical_data_updates_and_auditrecords&rev=1387613993&do=diff --- Jozef Aerts 2008/12/31 11:36 Clinical Data Updates and AuditRecords Author: Jozef Aerts, XML4Pharma Applicable to: ODM version 1.3 Updates of records in CDISC ODM The CDISC ODM has very good support for update of data points and for audit trails. As such, CDISC ODM is fully 21 CFR Part 11 compliant. text/html 2014-01-13T21:40:57+02:00 http://xml4pharmaserver.com/XML4PharmaWiki/doku.php?id=multiple_choice_questions_in_cdisc_odm&rev=1389645657&do=diff Multiple Choice Questions in CDISC ODM We regurarly get questions about “multiple choice” or “check all that apply” questions in CDISC ODM, i.e. questions that seemingly have a codelist, but for which it is allowed to check or select more than one answer. text/html 2013-12-21T09:19:53+02:00 http://xml4pharmaserver.com/XML4PharmaWiki/doku.php?id=odm_codelists_good_practice&rev=1387613993&do=diff ODM CodeLists Good Practice --- Jozef Aerts 2009/11/21 10:53 Author: Jozef Aerts, XML4Pharma Applicable to: ODM version 1.3, 1.2, 1.1 CodeLists and ODM CodeLists are used in ODM to limit the number (“enumerate”) of answers to a question that appears on an (e)CRF or within an ePRO page (other uses not excluded). They also allow to “localize” the text of the possible answers for different languages and cultures. text/html 2015-06-18T22:09:57+02:00 http://xml4pharmaserver.com/XML4PharmaWiki/doku.php?id=odm_referencedata&rev=1434658197&do=diff Recently I was asked by a customer to explain how ODM “ReferenceData” works. As I do not use it myself a lot, I went back to the ODM v.1.3.1. specification. It states: ”Reference data provides information on how to interpret clinical data. For example, reference data might include lab normal ranges”. text/html 2013-12-21T09:19:53+02:00 http://xml4pharmaserver.com/XML4PharmaWiki/doku.php?id=odm_units_of_measurement_and_ucum&rev=1387613993&do=diff THIS IS WORK IN PROGRESS!!! The use of UCUM for units of measurement in ODM Author: Jozef Aerts, XML4Pharma Applicable to: ODM version 1.3 The use of UCUM notation for units of measurement is rapidly growing. CDISC ODM itself does not prescribe a particular notation for units of measurement. All it does is stating that a unit of measurement (ODM element “MeasurementUnit”) must have an OID (identifier) and a Name (short description). So the following snippets may describe exactly the same uni… text/html 2013-12-21T09:19:53+02:00 http://xml4pharmaserver.com/XML4PharmaWiki/doku.php?id=some_bad_practices_frequently_encountered&rev=1387613993&do=diff I have helped quite a few organizations (sponsors, CROs, technology vendors) with implementation of the CDISC standards. Some of these have been able to obtain CDISC ODM certification thanks to this. Others however, did not consult a specialist, and moreover, did not read the ODM specification very well I am afraid, leading to non-compliant ODM files generated by their systems. Some implementers think that when their generated ODM files validate against the XML-Schema, they are safe. This is ho… text/html 2015-06-18T21:00:51+02:00 http://xml4pharmaserver.com/XML4PharmaWiki/doku.php?id=start&rev=1434654051&do=diff This Wiki currently contains a number of articles about the use of the CDISC ODM and other CDISC Standards. Most of these articles were meant as contributions to a “CDISC ODM Implementation Guide” which however has not been completed yet by the CDISC ODM team. text/html 2015-03-29T17:23:57+02:00 http://xml4pharmaserver.com/XML4PharmaWiki/doku.php?id=text_formatting_in_odm_-_is_it_possible&rev=1427642637&do=diff I was recently asked whether it is possible to add text formatting information in ODM. The person who asked me wanted to have underlining and bold support on question texts in the CRFs. Something like: “Is your quick brown fox jumping over the lazy dog?” text/html 2013-12-21T09:19:53+02:00 http://xml4pharmaserver.com/XML4PharmaWiki/doku.php?id=the_include_mechanism_in_cdisc_odm_study_descriptions&rev=1387613993&do=diff The "Include" mechanism in CDISC ODM Study descriptions Author: Jozef Aerts, XML4Pharma Applicable to: ODM version 1.3, version 1.2 Introduction The first possible element within the “MetaDataVersion” element of an ODM file containing a study design (i.e. lists of possible visits, forms, subforms, questions etc.) is the “Include” element. text/html 2013-12-21T09:19:53+02:00 http://xml4pharmaserver.com/XML4PharmaWiki/doku.php?id=the_use_of_ordernumber_in_cdisc_odm&rev=1387613993&do=diff --- Jozef Aerts 2012/07/05 20:16 The use of 'OrderNumber' in CDISC ODM There has been some confusion about the use of the 'OrderNumber' in 'StudyEventRef', 'FormRef', 'ItemGroupRef' and 'ItemRef' in CDISC ODM. The specification (ODM v.1.3.1) states for example for 'OrderNumber' in 'StudyEventRef': text/html 2013-12-21T09:19:53+02:00 http://xml4pharmaserver.com/XML4PharmaWiki/doku.php?id=uniqueness_of_oids_-_good_practice&rev=1387613993&do=diff --- Jozef Aerts 2008/12/31 11:36 Uniqueness of OIDs - Good Practice Author: Jozef Aerts, XML4Pharma Applicable to: ODM version 1.3 The OID uniqueness rules The ODM standard uses the 'OID' attribute as the unique identifier for studies, units of measurement, versions of the metadata, and down to codelists and methods definitions. The rules for uniqueness of OIDs has been described in section 2.11 (Element Identifiers and References). Essentially the rules are: text/html 2013-12-21T09:19:53+02:00 http://xml4pharmaserver.com/XML4PharmaWiki/doku.php?id=using_conditions_in_odm_1.3&rev=1387613993&do=diff Using Conditions in ODM 1.3 Author: Jozef Aerts, XML4Pharma Applicable to: ODM version 1.3 Introduction CDISC ODM Version 1.3 introduces the concept of “skip conditions”. Skip conditions are conditions under which a question (“Item”), a group of questions (“ItemGroup”), a form (“Form”) or a study visit (“StudyEvent”) may be skipped. text/html 2013-12-31T12:21:44+02:00 http://xml4pharmaserver.com/XML4PharmaWiki/doku.php?id=using_rangechecks_in_odm_1.3&rev=1388488904&do=diff Using RangeChecks in ODM 1.3 --- Jozef Aerts 2009/02/28 10:53 Author: Jozef Aerts, XML4Pharma Applicable to: ODM version 1.3, 1.2, 1.1 Introduction Rangechecks are very usefull in EDC: they allow to obtain much cleaner data in case the rangecheck is performed on the client where data is entered, i.e. when the client is configured so that (numeric) values outside the range given by the rangecheck are not accepted. Depending on the implementation, the user will receive a notice when enterin…