Minutes QRPH July 22-25 2008 Meeting

Agenda (Minutes) QRPH Technical Committee Meeting

July 22-25 2008

Attendees

Floyd Eisenberg, Siemens Healthcare (Co-chair) Jason Colquitt, Greenway Medical Systems (Co-chair) Ana Estelrich, DIP, GMP (Planning Committee Co-Chair) Landen Bain, CDISC Patty Craig, The Joint Commission Thomas Kuhn, ACP Shirley Neal, Misys Jacob Reider, Misys Mick Talley, University Bank Gary Walker, Quintiles

Quality Measure Value Set White Paper

• Comments and resolution: [1.doc Comments and resolution]
• Clean version: White Paper
• Track changes version: Track Changes Version

Clinical Research Data Capture Profile

Comment Resolution

• Active Version in Comment Resolution
• Signature requirements for Pre-clinical and Clinical Study Reports (Comment from Rich Furr, SafeBioPharma)
  • Pre-clinical and clinical study reports generally require multiple signatures prior to inclusion in a dossier that will be submitted in support of a new drug application (FDA) or marketing authorization application (EU).
  • Such requirements are defined in both US and EU regulatory documents that implement the ICH E3 requirements for Structure and Content of Clinical Study Reports, as follows:
    • “Where signatures of the principal or coordinating investigators are required by regulatory authorities, these should be included in appendix 16.1.5 (see Annex II for a sample form). Where these are not required, the signature of the sponsor’s responsible medical officer should be provided in appendix 16.1.5.”
  • In fact, in many cases, such reports include multiple signatures which may include study authors, sponsor reviewers and, finally, sponsor approvers. All such signatures could be applied using digital signature functionality to provide both non-repudiation and long-term signature persistence. The use of simple electronic signatures does NOT provide such capabilities and would not support long-term audit/inspection requirements.
  • Further, ICH Good Clinical Practices identify other documents, e.g., electronic case report forms (eCRF), eCRF correction sheets, also require signatures which may be applied using digital certificates to provide the same strength as cited above.
  • In each of these instances, we believe the digital signatures applied to the CDISC ODM could provide the needed support.

Digital Signature Suggested Content