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Debbie ★ India, 2010-01-12 18:26 (5597 d 02:58 ago) Posting: # 4588 Views: 5,995 |
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Hi, i have a query regarding the approval of the protocol by sponsor, can a sponsor approve a protocol before investigators approval (principal, clinical investigator etc.)? Regards, DB. Edit: Category changed. [Helmut] |
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Ohlbe ★★★ France, 2010-01-12 18:37 (5597 d 02:48 ago) @ Debbie Posting: # 4589 Views: 4,933 |
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Dear Debbie, ❝ 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 |
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Dr_Dan ★★ Germany, 2010-02-04 14:15 (5574 d 07:10 ago) @ Ohlbe Posting: # 4708 Views: 4,799 |
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Hi as long as sponsor and investigator agree on signing the same protocol version the date of signature should be of no importance as long as it is before study start. — Kind regards and have a nice day Dr_Dan |
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ray_be ☆ India, 2010-02-04 19:21 (5574 d 02:04 ago) (edited on 2010-02-04 21:56) @ Ohlbe Posting: # 4709 Views: 4,771 |
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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. -- Edit: quotation marks restored [Ohlbe] |
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Ohlbe ★★★ France, 2010-02-04 22:59 (5573 d 22:26 ago) @ ray_be Posting: # 4710 Views: 4,778 |
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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 — Regards Ohlbe |
Ing. Helmut Schütz