Effective February 2019, the FDA will require device trials conducted outside of the U.S. to state whether they conformed to GCP standards. While many sponsors may already be conducting international device trials in accordance with GCP standards, this confirmation of compliance with GCP standards will be mandatory.
See Full FDA Guidance
Train Your Staff in GCP
CITI Program's base subscription includes GCP courses and is a turnkey solution to train and manage entire groups affordably. Basic and advanced courses are available and up to date with current regulations and guidelines.
These courses provide essential GCP training that covers ICH E6(R2), ISO 14155:2011, and FDA regulations for clinical trials. They are tailored to clinical research of drugs, biologics, and devices.
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