Bioequivalence and Bioavailability Forum

Dear Debbie,

❝ ❝ can a sponsor approve a protocol before investigators approval (principal,

❝ ❝ clinical investigator etc.)?

Yes, if sponsor is responsible for the protocol developement, which is more common in Phase II - IV studies.

Dear Ohlbe,

❝ 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.

IMHO, logically speaking it is not very satisfactory for a BE study protocol, if the protocol is prepared by a CRO and all the investigators viz. principal, clinical, bioanalytical, statistical and pharmacokinetics are from CRO side. 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?

Regards

Ray.

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Edit: quotation marks restored [Ohlbe]