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RegisterProtocol and Clinical Report [Study Performance]
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
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
Complete thread:
- Protocol and Clinical Report chiragkhatri 2008-10-21 08:48
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Protocol and Clinical Report shankar 2008-10-25 12:33
- Protocol and Clinical ReportOhlbe 2008-10-26 00:08
Ing. Helmut Schütz