2008-04-03 Clinical Research Data profile meeting minutes
Clnical Research Data profile meeting
- Attendees
- 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 draft of the Clinical Research Data profile. During the May 1 face-to-face, finalize for public comment.
Discussion: pseudonimization of CCD data
Certain data elements, birthday for example, which CDASH requires, HIPAA forbids. A trucated birday -- year and month only -- would suffice for research purposes. Lori suggest that work from HITSP might help guide us through these waters: <a href="http://www.hitsp.org/ConstructSet_Details.aspx?&PrefixAlpha=3&PrefixNumeric=24"> HITSP Pseudonymize Transaction </a> and the <a href="http://www.hitsp.org/ConstructSet_Details.aspx?&PrefixAlpha=4&PrefixNumeric=25">HITSP Anonymize Component </a> .
Mapping of CCD to CDASH
At the last PCC meeting, George Cole proposed using CCD as the export mechanism from the Form Filler, with the Form Manager extended to serve as a gateway, a translator, between CCD and CDASH. 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.