Q&A 31 : What is the responsibility if the CRO is in charge of drafting the protocol?

“What is the responsibility if the CRO is in charge of drafting the protocol?”

ICH GCP Ref: 5.0 ; 5.0.1 – 5.0.7 ; 5.2.2

A risk assessment (ideally jointly with the sponsor) should be conducted, beginning with evaluating what is critical and identifying/evaluating the risk around it, where possible agreeing risk reduction/elimination with the sponsor and if not, then agreeing risk controls to implement and monitor (in the wider sense of the word) during the trial. I would recommend that the functions involved in the trial are involved in the risk assessment process.

    Tammy Finnegan, COO tammy.finnigan@tritrials.com

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