Sample Management Randomization Presentation

Meeting minutes

Subject: German CDISC User Group, Workstream ODM Kick Off Meeting (TC)

Meeting Location / Penzberg Date: October 22nd, 2008,

Participants: Jozef Aertz Uwe Lahr Markus Stoll Michael Walter (minutes)

Copies: Fred Kiefer Daniel Rehn

1 QUESTIONS RESULTING FROM THE CDISC USER GROUP MEETING ND ON SEPTEMBER 02 Attached there are some questions resulting from the CDISC User Group Meeting on September, 02nd and the answers provided by Jozef.

a)Further development of CDISC ODM The answer is "Yes". The ODM team is currently setting up a "wish list" within the CDISC Portal. See 2.

b)CDISC ODM V. 1.3 ODM Checker A total rewrite of the ODM Checker software, specifically for ODM 1.3, has been developed by a student at the university of Heidelberg (for his thesis). At point of time it will be finished, Jozef will make it publicly available.

c)Proc CDISC Development SAS has developed the ETL-studio, therefore Jozef is very pessimistic that the Proc CDISC will be further developed by SAS.

d)Will the Layout Extension become part of the CDISC ODM standard Though there are many requests for this, the ODM team decided not to do this. The reason is that there are so many possible ways to add layout, so it is never possible to develop something that satisfies most of the people. Furthermore there are international standards, such as CSS, which can be

used for rule-based layouting. Not to speak about specific forms implementations such as XForms and InfoPath. CDISC however keeps an eye on other international, XML-based standards, to see whether something widely accepted is or becomes available.

e)Vendor Extensions and Proc CDISC PROC CDISC has very tough requirements about how an ODM file must be organized. Also it does not load ODM 1.3. Maybe there is a customer related solution needed, which transforms the CDISC ODM version (including its vendor extensions) in one version loadable by Proc CDISC.

f) Homogenous Standardization Publishing the CDASH forms as ODM for example is surely one step for better integration of SDTM in ODM. Another is controlled terminology. The CDASH-ODM will very probably contain all SDTM controlled terminology as ODM CodeList's. The ODM team together with the Protocol team will also soon publish an ODM-extension for trial design. Unfortunately (to my personal opinion) there is currently also a tendency in the opposite direction, as the FDA has decided that it will not use ODM- extensions for submission data (such as SDTM), but wants to (have) develop(ed) HL7-v3-XML messages instead. Maybe this ends up with two protocol-xml representations: one ODM-based for automated setup of EDC and CDMS, and one as HL7-XML for submission to the FDA (who doesn't care about automated setup of data capture systems).

g)Wiki containing “use cases” The web site containing CDISC ODM “use cases” can be accessed by using following link: http://asserowiki.com.

2 WISH LIST CDISC ODM 1.4 Jozef explained the topics of the wish list for CDISC ODM 1.4.

ODM_1_4_wishlist_2 008_09_09.pdf

3 MEMBERS FOR GERMAN CDISC ODM WORKSTREAM Jozef will forward a list of possible members who are interested in participating in the German CDISC ODM workstream to Michael. Michael will invite these additional members. Responsible: Jozef/Michael

4 NEXT GERMAN CDISC ODM WORKSTREAM MEETING January, 14th 2009, 2 – 5 pm (TC) Page 2 of 3

Michael Walter