http://www.xml4pharmaserver.com/XML4PharmaWiki/ 2010-04-01T05:32:36+02:00 http://www.xml4pharmaserver.com/XML4PharmaWiki/ http://www.xml4pharmaserver.com/XML4PharmaWiki/lib/images/favicon.ico text/html 2010-03-28T11:20:52+02:00 xml4pharma 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 2010-03-28T08:48:53+02:00 xml4pharma 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 2010-02-26T11:54:37+02:00 xml4pharma 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 2010-01-14T17:29:25+02:00 xml4pharma 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…