http://www.xml4pharmaserver.com/XML4PharmaWiki/ 2010-04-01T20:49:45+02:00 http://www.xml4pharmaserver.com/XML4PharmaWiki/ http://www.xml4pharmaserver.com/XML4PharmaWiki/lib/images/favicon.ico text/html 2010-02-26T11:54:37+02:00 http://www.xml4pharmaserver.com/XML4PharmaWiki/doku.php?id=annotating_odm_with_sdtm_and_cdash_information&rev=1267181677&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 2008-12-31T17:53:39+02:00 http://www.xml4pharmaserver.com/XML4PharmaWiki/doku.php?id=cdisc_odm_in_multi-language_studies&rev=1230742419&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 st… text/html 2010-03-28T11:20:52+02:00 http://www.xml4pharmaserver.com/XML4PharmaWiki/doku.php?id=clinical_data_updates_and_auditrecords&rev=1269768052&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 2009-11-24T21:05:25+02:00 http://www.xml4pharmaserver.com/XML4PharmaWiki/doku.php?id=odm_codelists_good_practice&rev=1259093125&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 2010-01-14T17:29:25+02:00 http://www.xml4pharmaserver.com/XML4PharmaWiki/doku.php?id=some_bad_practices_frequently_encountered&rev=1263486565&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 2010-03-28T08:48:53+02:00 http://www.xml4pharmaserver.com/XML4PharmaWiki/doku.php?id=start&rev=1269758933&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 2009-06-23T12:17:34+02:00 http://www.xml4pharmaserver.com/XML4PharmaWiki/doku.php?id=the_include_mechanism_in_cdisc_odm_study_descriptions&rev=1245752254&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 2009-11-23T10:45:48+02:00 http://www.xml4pharmaserver.com/XML4PharmaWiki/doku.php?id=uniqueness_of_oids_-_good_practice&rev=1258969548&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 2009-08-03T09:40:26+02:00 http://www.xml4pharmaserver.com/XML4PharmaWiki/doku.php?id=using_conditions_in_odm_1.3&rev=1249285226&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 2009-02-28T13:54:28+02:00 http://www.xml4pharmaserver.com/XML4PharmaWiki/doku.php?id=using_rangechecks_in_odm_1.3&rev=1235825668&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 ente…