Good Clinical Practice Training

All NIH-funded clinical investigators and clinical trial staff who are involved in the design, conduct, oversight, or management of clinical trials can learn about the requirement to be trained in Good Clinical Practice (GCP). Effective date: January 1, 2017.

Purpose

The principles of Good Clinical Practice (GCP) help assure the safety, integrity, and quality of clinical trials by addressing elements related to the design, conduct, and reporting of clinical trials. GCP training describes the responsibilities of investigators, sponsors, monitors, and IRBs in the conduct of clinical trials. 

GCP training aims to ensure that:

  • the rights, safety, and well-being of human subjects are protected
  • clinical trials are conducted in accordance with approved plans with rigor and integrity
  • data derived from clinical trials are reliable

Training Options

The policy does require a particular GCP course or program. Training in GCP may be achieved through a class or course, academic training program, or certification from a recognized clinical research professional organization. NIH also offers GCP training. See NIAID and NIDA. In addition, NCATS has developed a GCP training program geared to behavioral clinical trial investigators . These courses are free of charge. Other free courses as well as fee-based courses are available.

Policy Guidelines & Implementation

Effective January 1, 2017 – NIH expects all NIH-funded clinical investigators and clinical trial staff who are involved in the design, conduct, oversight, or management of clinical trials to be trained in Good Clinical Practice (GCP).

Recipients of GCP training are expected to retain documentation of their training. GCP training should be refreshed at least every three years in order to stay up to date with regulations, standards, and guidelines.

Notices