Good Clinical Practice (GCP) CITI Training
Frequently Asked Questions
I will be conducting a clinical trial study. Which Good Clinical Practice (GCP) CITI training course should I take: Group 1, Group 2, or Group 3?
All investigators and research staff who are involved in the design, conduct, oversight or management of NIH-funded clinicals trials must be trained in GCP. It is recommended that learners complete the GCP course that is most germane to the type of research they will carry out.
Group 1: GCP for Clinical Trials (FDA Focus) - Investigators and/or
Team Members
This course is ideal for investigators and research staff
who will be conducting clinical trials of drugs, biologics, and devices mainly in the U.S. and/or who prefer a program that is
more U.S. FDA-focused. After completing the course,
learners will gain understanding of the federal regulations,
International Council for Harmonisation (ICH) guidelines (including
ICH E6(R2)), and Good Clinical Practice (GCP) standards for clinical
research. The Group 1 module (English only) satisfies the Minimum
Criteria for ICH GCP Investigator Site Personnel Training mutually
recognized by TransCelerate BioPharma and clinical trial sponsors.
Group 2: GCP for Clinical Trials (ICH Focus) - Investigators and/or
Team Members
This ICH-centric course is ideal for investigators
and research staff who will be conducting clinical trials of drugs and biologics in the U.S. and internationally and/or when researchers wish for a training
program that is more internationally focused or where ICH training is required. After completing the course, learners will gain understanding of
ICH GCP E6 standards and of U.S. FDA regulations and guidelines. The
Group 2 module (English only) satisfies the Minimum Criteria for ICH
GCP Investigator Site Personnel Training mutually recognized by
TransCelerate BioPharma and clinical trial sponsors.
Group 3: GCP for Clinical Investigations of Devices - Investigators
and/or Team Members
This device-centric course is suited for
investigators and research staff who will be conducting clinical investigations
of devices in the U.S. and internationally.
The course offers an overview of investigator responsibilities and the
role of international standards on clinical research, including
managing investigational devices in accordance with GCP requirements,
monitoring, audits and inspections, and informed consent process.
After completing the course, learners will gain an understanding of
the U.S. FDA regulations, International Organization for
Standardization Guidelines (ISO) 14155:2011, and GCP standards for
clinical research.
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