Program Overview

Good Clinical Practice (GCP) Training

Good Clinical Practice is the international ethical and scientific standard expected in the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials. Compliance with GCP provides assurance that data are reported, results are credible and accurate, and that the rights, safety, confidentiality, and well-being of trial participants are protected.

Overview of GCP Training

The National Institutes of Health (NIH) has issued a policy on GCP training for NIH awardees involved in NIH-funded clinical trials. This policy requires that primary investigators and clinical trial staff involved in all new and ongoing NIH-defined clinical trials complete GCP training.

Key Points of the NIH Policy

• This policy applies to investigators and clinical trial staff who are responsible for the conduct, management, and oversight of NIH-funded clinical trials.
• For new NIH-funded clinical trials, documentation of training completion must be provided as part of the just-in-time process.

GCP Training Requirements

Who is Required to Complete the GCP Training?

All key research personnel involved in NIH-funded clinical trials are expected to document the completion of GCP training. Key research personnel include principal investigators, sub-investigators, research coordinators, and any other research team members who are involved in the design, conduct, or reporting of clinical trials involving human participants.

Which GCP Modules Should I Complete?

Select the following course applicable to the research in which you are involved to satisfy the requirement for GCP training:

• GCP Training for Clinical Trials Involving Drugs, Biologics, and Devices
• GCP Training for Social Behavioral Research If you are involved in biological, drug, or device research, as well as social and behavioral research, you are required to complete the CITI GCP training for clinical trials involving drugs, biologics, and devices. If you have taken the CITI GCP training for biologics and drugs and devices, you do not have to take the additional social and behavioral GCP training if you are involved in social and behavioral research.

When Do I Need to Complete This Training?

For new NIH-funded clinical trials, you must provide documentation of training completion as part of the just-in-time process. The new NIH policy requires GCP training to be refreshed every three years in order to remain current with regulations, standards, and guidelines.

How Long Will It Take to Complete the Modules?

This will depend on your experience with human research issues. Most modules will take about 10-20 minutes to complete. Researchers familiar with these topics may require three hours or less to complete all of the required modules. You do not have to complete all the modules at once.

What is Considered a Passing Score?

• The required passing score if you are taking the CITI modules is 70%. The score is based on the overall score from all the required modules.
• The required passing score if you are taking the SBM modules is 100%. This has been set by the Society for Behavioral Medicine who sponsors and administers the training site.

Verification and Maintenance of GCP Training

How Do I Verify My GCP Training?

To verify successful completion of the required CITI training, you must log the completion date in your profile. Once a person's CITI or SBM training date is logged in their profile, it will be automatically populated in any new study submission.

Refreshing GCP Training

The new NIH policy requires GCP training to be refreshed every three years in order to remain current with regulations, standards, and guidelines. Do not forget to update your profile when you complete the required refresher course every three years.