Q&A 28 : Would you generally consider an “important” process like consent a “critical” process from a risk management perspective?

“Would you generally consider an “important” process like consent a “critical” process from a risk management perspective – for example if you have an optimized process for consenting, no historical issues with the consent process, and nothing unique about the study that would increase risk (vulnerable subjects or multiple consents), could you omit the consent process from your list of critical processes? “

ICH GCP Ref: 5.0.1

Great question, I would still consider it a critical process in terms of subject well being and protection, but in terms of evaluation I might rate it low probability, medium-high impact and easy to detect, and if I have good processes in place and there have been no issues with consent deviations or CAPAs in the past and there is nothing unusual about the consent process in the protocol e.g. vulnerable populations, I might state that there is low/negligible risk to this critical process, and it is controlled by my standard processes. It is acceptable to state that there is no or negligible risk associated with a critical process, just because its critical does not mean there is risk associated with it.

    Tammy Finnegan, COO tammy.finnigan@tritrials.com

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