01-16-2014 minutes

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Attendees:

  • Sue DeHaven, Debra Oetzman

Topics Discussed:

  • Review of sample nonclinical SDRG
  • Plan for next meeting

Minutes:

  • Re-reviewed a bit of sample SDRG created by Laura K. (Reviewers Guide Study 1234) and compared to Clinical Sample (SDRG_example_ABC123) . Assessment of today:
  • Generally same feeling as in last meeting - concern for duplication of work in SDRG.
    - Section 2.1 Protocol information - extra info beyond Protocol number, title and versions not needed for nonclinical. (as Clinical sample) Info is already many places.
    - Section 2.5 - Study Design - in nonclinical example, extensive descriptions and re-

statement of labels may generate more confusion than clarification. Understood that complex study design may need extra guidance to reviewer. Need to assess how elements, arms, sets etx show up on Toxvision to understand how much explanation is needed for the trial design domain content. Hopefully they speak better for themselves.

  • Sanofi and Covance will independently write an SDRG for same study (using I-SEND pilot study) - target to discuss outcome @Feb 13th meeting. (stretch target for Jan 30)
  • Jan 30th meeting extended to 2 hours, with target to finish comparison of Study 1234 sample with Clinical sample.
  • Noted that we only have one CRO participating - if anyone can recruit another, let us know!