2008-04-03 Clinical Research Data profile meeting minutes

Clnical Research Data profile meeting, Thursday, April 3, 2008

Scribe: Landen Bain, who welcomes edits. It's a wiki!

Keith Boone, GE, PCC co-chair
Landen Bain, CDISC, proposal editor
Gary Walker, CDISC, profile editor
Rhonda Facile, CDISC, profile editor
Dave Jones, CDISC
Simon Boichat, CDISC
Daemon Whittenburg, Greenway Medical
Lori Fourquet
Steve Moore

Process

Between now and the next face-to-face meeting, develop a draft of the Clinical Research Data profile. During the May 19 face-to-face, finalize the draft for public comment.

Pseudonimization of EHR data for Clinical Research

Certain data elements, birthday for example, which CDASH requires, HIPAA forbids. Workarounds exist, for example a truncated birthday -- year and month only -- would suffice for research purposes and avoid HIPAA censure. Lori suggest that two documents from HITSP might help guide us through these waters: HITSP Pseudonymize Transaction and HITSP Anonymize Component.

Mapping of CCD to CDASH

At the last PCC meeting, George Cole proposed using CCD as the export format from the EHR's Form Filler, with the Form Manager extended to serve as a gateway, a translator, between CCD and CDASH. Discussion clarifies the role of CDASH & ODM and the corresponding CCD & CDA. Gary Walker agrees to lead a sub-group to look into the mapping between CCD and CDASH, calling on Dave Jones, Daemon Whittenburg, and George Cole for assistance.

Sufficiency of CDASH

Dave Jones points out that some studies might require pre-population of data that CDASH does not cover. Rhonda confirms this. Should we allow the study sponsor to negotiate with the EHR to go beyond CDASH? This would require extra work for both the Form Filler and the Form Manager, but might make sense in some specific cases. Landen suggests including this as an optional extension. Keith would prefer to stick to the current scope.

Digital Signature

Lori reminds us that there is an ITI discussion underway for inclusion of Digital Signature inside of RFD.