Q&A 29 : How does the CRO receive Sponsor’s delegation to quality management actions?

“How does the CRO receive Sponsor’s delegation to quality management actions? Any specific message mandatory for us (CRO) being responsible?”

ICH GCP Ref: 5.0 ; 5.0.1 – 5.0.7 ; 5.2.2

This should be worked out as part of the contract, but it is worthwhile to have your own SOPs that cover the process of quality (risk) mgmt. I often recommend that it is good practice to perform an early critical variable and risk assessment as part of the RFP process. As the sponsors representative for the areas that are delegated to you (the CRO) you will have some level of responsibility for identifying and managing the risks in conjunction with the sponsor. I would recommend as a best practice that you (the CRO) has a risk assessment and mgmt. process in place and conduct your own risk assessment of the protocol, this process can also be conducted in conjunction with the sponsor (ideally a joint process would be conducted). The outcome of risk assessment, as you will see as the presentation progresses, should inform the functional activities and functional plans, e.g. Monitoring, Data Mgmt, Supplies etc.

    Tammy Finnegan, COO tammy.finnigan@tritrials.com

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