Meeting Minutes

CDISC-HL7 Stage II May 25, 2011 11:00 am (EST)

Attendees First Name Last Name Affiliation E-mail Address Michael Brennan Johnson & Johnson Bill Friggle Sanofi-Aventis [email protected] Patty Garvey FDA [email protected] Allen Glover Covance [email protected] Joyce Hernandez Merck [email protected] Jay Levine FDA [email protected] Armando Oliva FDA [email protected] Mitra Rocca FDA [email protected] Lise Stevens FDA [email protected] Mead Walker Mead Walker Consulting [email protected] Diane Wold GSK [email protected]

Discussion  Introduce Mead Walker as our new modeling facilitator.

 Review of Subject Data ballot status Subject Data submitted for DSTU ballot in September 2009. Following the ballot review period, Jason Rock did review the ballot comments with the Stage II working group. However, it was not formally reconciled through the HL7 process because it was discussed that subject data requirements would be included in the Structured Document CDA r3 ballot submission. It was anticipated that once the CDA r3 was balloted and the working group determined that subject data requirements were included then the subject data ballot would then be withdrawn. However, CDA r3 balloting has continued to be delayed.

In review of this project, FDA decided that it would move forward with the reconciliation process for the September 2009 subject data ballot. Because it has been over a year and half since Stage II discussed the ballot comments, Patty thought it would be best to have Mead re-review the ballot comments with the working group before submitting it to RCRIM for approval.

The review of the Subject Data ballot will start at the next meeting, June 8, 2011. Page 2

 FDA is currently working on mapping the Study Participation, Study Design and Subject Data models to SDTM. The following are reason why this mapping exercise is being done: o Harmonization with BRIDG, which is the domain analysis model for RCRIM. o Need to map SDTM 3.1.2 to Clinical Statement. Both Study Design and Subject Data models point to the Clinical Statement.

 CDA vs Message discussion o Mead to review Study Participation and Study Design RMIM to see if these would meet CDA r2 standard. o CDA r3 anticipated to be submitted for DSTU ballot Spring 2012. o Why implement CDA? – easier, stable schema, structure document workgroup can help us create Implementation Guide. o CDA is based on the RMIM and looks similar to Clinical Statement model. THe difference is that CDA strip out the complexity of Clinical Statement because the designer wanted to make it easier to implement CDA. o What are the business cases? Study Participation would want investigator’s CV. Study Design would include protocol document with structure of description of study design. Functionally, CDA and a Message can support both of these use cases. o The advantage of message – using functional rule and not needing to stretch the standard. o The advantage of CDA – firm schema managing rules and no wrapper is needed. o The difficult in CDA – complex matching of status, i.e. cancel order, delete, etc. o The decision whether the standard should be CDA or Message should be based on which would be easier to implement. A document can be implemented inside a message.

 Next meeting scheduled for Wednesday, June 8th at 11:00am to 12:00pm EST. The agenda will be to start reviewing the Subject Data DSTU September 2009 ballot comments.

Drafted: PGarvey