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chiragkhatri ★ India, 2008-10-21 10:48 (6101 d 23:58 ago) Posting: # 2569 Views: 5,695 |
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Dear All, We have a procedure wherein Management Representatives (MR) signature is taken on Protocol and Clinical Report. Is it mandatory to take MR signature or final authorization by PI is sufficient. Any guidelines references are welcome. Thanks Chirag |
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shankar ★ India, 2008-10-25 14:33 (6097 d 20:14 ago) @ chiragkhatri Posting: # 2580 Views: 4,402 |
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Dear Chirag, I think whatever procedure/Sop you are following you have stick to that. According to your procedure both MR and PI signature should be there. Thanks, — Shankaranarayanan |
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Ohlbe ★★★ France, 2008-10-26 02:08 (6097 d 08:39 ago) @ chiragkhatri Posting: # 2583 Views: 4,382 |
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Dear Chirag, According to the ICH GCP guideline, §4.5.1: The investigator/institution and the sponsor should sign the protocol, or an alternative contract, to confirm agreement. The protocol should be signed by the investigator or the sponsor. Whether you want somebody else to sign it too is for you to decide, but is not required by the guideline. Delegation of duties from the sponsor to a CRO should be defined in writing (§5.2.2 in the same guideline), but this will be through a contract (signed by the management of the CRO, not by the investigator), not in the protocol. Regarding the signature of the report: the ICH E3 guideline only refers to the signature of the investigator or of the sponsor's responsible medical officer. Regards Ohlbe |
Ing. Helmut Schütz