Minutes QRPH July 22-25 2008 Meeting

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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
  • Michael Ibara, Pfizer
  • Thomas Kuhn, ACP
  • Shirley Neal, Misys
  • Jacob Reider, Misys
  • Mick Talley, University Bank
  • Gary Walker, Quintiles

Quality Measure Value Set White Paper

Tuesday, July 22, comment resolution was completed. Detailed comments are located at:

Clinical Research Data Capture Profile

Comment Resolution

  • Comments resolved. Discussion regarding digital signature (details below) led to decision to include digital signature requirements in the Drug Saftey Content White Paper. The digital signature is part of the envelope in which the content is sent. The current Clinical Research Content Profile is specific to content. Digital signature and the envelope is intended for a proposal to QRPH Planning Committee for 2009 work effort.
  • 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.”
      • SafeBioPharma Presentation
    • 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

      • After some discussion it was agreed that digital signature is not in scope for the content of the message. The Clinical Research Data Capture Profile is specific to the message content. Therefore, digital signature requirements can be met through other ITI constructs and not directly within the context of Clinical Research Data Capture Content.

Drug Safety Content Profile

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