Hello Erin,

I worked in an FDA regulated environment for 6 years at a biopharmaceutical company. The answer to your question is "yes, anyone working on a clinical trial" need to be GCP trained. The clinical trials are being reported to the FDA and you want that study to be solid. FDA will review training records of all those involved in the study.

Hope this helps.

Regards,
Nihal Sarikaya, MAdm
Grant & Project Support Coordinator
Steve Sanghi College of Engineering
Northern Arizona University

-----Original Message-----
From: xxxxxx@lists.healthresearch.org <xxxxxx@lists.healthresearch.org> On Behalf Of Erin Fogarty
Sent: Monday, January 6, 2025 11:14 AM
To: xxxxxx@lists.healthresearch.org
Subject: [RESADM-L] Quick question re: GCP and clinical trials

I'm used to all clinical faculty having their GCP certification (Good Clinical Practice) regardless of the type of trial?
My VP is asking if fellow or students need to be GCP certified before participating in a clinical trial (a non-NIH clinical trial).
        I disagree and welcome anyone's experience on this topic.
And, does your institution have a carve out for studies, in cases such as chart reviews (meaning GCP not required -assuming it's not an NIH clinical trial).

Any input welcome.

Erin Fogarty, MA, CRA
Executive Director, MetroHealth Research Institute (affiliated with Case Western Reserve University)

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