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RegisterSponsor approval of a protocol [GxP / QC / QA]
Dear Debbie,
Why not ? The investigator and the sponsor should both sign the protocol, but there is no order specified in GCP. I would even say that in Phase II - IV studies the sponsor usually signs before the investigators. The situation is often different in BE trials when the protocol is written by a CRO and not directly by the sponsor, but I am not aware of any restriction in GCP.
Regards
Ohlbe
❝ can a sponsor approve a protocol before investigators approval (principal,
❝ clinical investigator etc.)?
Why not ? The investigator and the sponsor should both sign the protocol, but there is no order specified in GCP. I would even say that in Phase II - IV studies the sponsor usually signs before the investigators. The situation is often different in BE trials when the protocol is written by a CRO and not directly by the sponsor, but I am not aware of any restriction in GCP.
Regards
Ohlbe
Complete thread:
- Sponsor approval of a protocol Debbie 2010-01-12 17:26
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Sponsor approval of a protocolOhlbe 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 protocol Ohlbe 2010-02-04 21:59
- Sponsor approval of a protocolOhlbe 2010-01-12 17:37
Ing. Helmut Schütz