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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).
NIH considers clinical trial investigators the individuals responsible for the conduct of the clinical trial at a trial site and they may be called the principal investigator. Clinical trial staff are individuals, identified by the investigator, who are responsible for study coordination, data collection and data management. Clinical trial staff may also be called the research coordinator, study coordinator, research nurse, study nurse or sub-investigator.
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
Applicability
The policy applies to all active grants and contracts.
Training Options
The policy does not 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 that is free of charge, including:
- Good Clinical Practice Course (NIDA)
- Good Clinical Practice in Social & Behavioral Research (NCATS/OBSSR)
- For NIH Researchers, click here
- For NIH Employees, click here
GCP training should be refreshed at least every three years in order to stay up to date with regulations, standards, and guidelines.
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.