Q&A 18 : What would be an example of a risk control at an organizational level?

“What would be an example of a risk control at an organizational level? You stated risk control can be at a study, site, organization level?”

IGH GCP Ref: 5.0.4

This is typically a change at a procedural level, similar to CAPA, putting preventative measures in place to avoid risk may be as a result of persistent breach of QTLs or the same risk emerging in many trials.

It may also be related to vendors, if root cause has pin pointed risk with a particular vendor, they may be removed from the ‘approved vendor’ list.

  Tammy Finnegan, COO  tammy.finnigan@tritrials.com

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