Bioequivalence and Bioavailability Forum

Sponsor approval of a protocol [GxP / QC / QA]

posted by Ohlbe – France, 2010-02-04 22:59 (5573 d 18:42 ago) – Posting: # 4710
Views: 4,776

Dear Ray,

❝ Because unless they give their consent on the protocol i.e. approval by

❝ signing, how come the sponsor will come to know whether the protocol

❝ is a final one or not?

Well... I would expect a draft protocol to be identified as "Draft" and the final version to be identified with "Final"

More seriously: as both sides have to sign the protocol, and as both sides have to retain a copy of the signed protocol, I don't see any issue.

Regards
Ohlbe

Complete thread:

• Sponsor approval of a protocol Debbie 2010-01-12 17:26 
  • Sponsor approval of a protocol Ohlbe 2010-01-12 17:37
    • Sponsor approval of a protocol Dr_Dan 2010-02-04 13:15
    • Sponsor approval of a protocol ray_be 2010-02-04 18:21
      • Sponsor approval of a protocolOhlbe 2010-02-04 21:59