Q&A 16 : Should the risk identification take place during the development of the protocol or when the protocol is finalized?

“When should the risk identification take place? During the development of the protocol or when the protocol is finalized? Who/what expertise would you expect to be at the risk identification meeting?”

IGH GCP Ref: 5.0.1

It is an ongoing process, but should be initiated during the protocol development cycle, as early as possible, ideally with the robust synopsis where the objectives can be evaluated. The extent of the assessment will expand, more functions will become involved as more detail is added to the protocol. Any changes from the draft to the final should be assessed as control measures may change and risks may close depending on the changes.

During the conduct phase, processes should be in place to support the identification of emerging risk, which should go through the same evaluation process to determine the appropriate controls.

  Tammy Finnegan, COO  tammy.finnigan@tritrials.com

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