Meeting Minutes
CDISC-HL7 Stage II
September 28, 2011
11:00 am (EST)
Attendees
First Name
Joan
Michael
Bill
Patty
Jay
Amy
Armando
Anna
Mitra
Lise
Clyde
Mead
Last Name
Affeck
Brennan
Friggle
Garvey
Levine
Malla
Oliva
Pron-Zwick
Rocca
Stevens
Ulmer
Walker
Affiliation
Sanofi-Aventis
J&J
Sanofi-Aventis
FDA
FDA
FDA
FDA
AstraZeneca
FDA
FDA
FDA
Mead Walker Consulting
E-mail Address
Joan.affleck@sanofi-aventis.com
MBrenna3@its.jnj.com
william.friggle@sanofi-aventis.com
patricia.garvey@fda.hhs.gov
Jonathan.levine@fda.hhs.gov
Amy.malla@fda.hhs.gov
Armando.oliva@fda.hhs.gov
Mitra.rocca@fda.hhs.gov
Lise.stevens@fda.hhs.gov
clyde.ulmer@fda.hhs.gov
dmead@comcast.net
Discussion
 Armando provided a slide presentation (attached below) updating the project
discussion held during the RCRIM working group meeting at HL7 San Diego.
Slide # 6: Study Participation Update:
o Michael asked whether the curriculum vitae (CV) can be in a structure form
rather than PDF.
o Armando thought that a modify RMIM can capture PDF or a more structure
document in the future. Mead stated that Observation using text attribute
allows for encapsulated data i.e. pdf, word, text, etc.
o Bill suggested a good starting point would be to review Firebird simplified CV.
o For the phase 1 testing of patient narratives, the information FDA captures
now is sufficient for testing. A structure CV may be in future releases.

Currently, there is one project statement which includes four standards – study
participation, study design, subject data and individual case safety report (ICSR). It
may be best to split the project activities into their own project scope statement.

Mead has drafted a project scope statement for a CDA Implementation Guide Subject
Data specifically for patient narratives (attached below). This draft project scope
statement was distributed for today meeting, but there was insufficient time to review
the statement.
Page 2

As part of this Project Scope Statement, FDA needs to indicate two implementers.
FDA will be one of the implementer but FDA is looking for other volunteers as
implementers. Patty asked people to discuss this with their company’s management.

FDA will have a XForm and style sheet available in November or December to use in
testing patient narratives. Michael indicated that he will share this information at the
October Pharma meeting.
Attachments (2):
1. Project Update
2011-09-28
CDISC-HL7 Update from HL7 Mtg.ppt
2. DRAFT CDA Implementation Guide Subject Data: Patient Narratives
2011.09.23_StudyD
ataCDA_PSS.doc
Drafted: PGarvey