Overview
In 2016, NIH issued a policy establishing an expectation that all NIH-funded investigators and staff involved in conducting, overseeing, or managing clinical trials should be trained in Good Clinical Practice (GCP) and should refresh their training at least every three years.
The principles of GCP ensure the safety, integrity, and quality of clinical trials. GCP provides a standard for compliance, implementation, data collection, monitoring, and reporting, and outlines the responsibilities of Institutional Review Boards (IRBs), investigators, sponsors, and monitors.
Training in GCP principles helps investigators and clinical trial staff protect the rights, safety, and well-being of human subjects. It ensures that clinical trials are conducted according to approved plans with rigor and integrity, and that the data collected is reliable.
Course Material Updates
In 2024, course material was updated to provide more comprehensive guidance. These updates include:
- Additional training on regulatory changes and reporting requirements
- Enhanced accessibility features for easier navigation
- A new module on community and stakeholder engagement
How to Access the Training
The course materials are free to access and use. There are several ways to access the training:
- NIH-Funded Researchers (extramural): Access the course on the Society for Behavioral Medicine’s website.
- NIH Employees: Access the course through the NIH Learning Management System (LMS) (NIH login required).
- Educational Institutions: Download the materials for your institution’s LMS using the links below.
Downloading the Course Materials
Download the files below and upload them to your institution’s LMS. Detailed instructions are available on our website.
Upon successful completion of the modules, the LMS will generate a certificate of completion for the learner to print or save. Successful completion requires working through all 10 modules and passing the included knowledge tests and exercises. The course tracks progress within your institution’s LMS.
- Introduction - Download zip file (26 MB)
- Research Protocol - Download zip file (27 MB)
- Recruitment and Retention - Download zip file (25 MB)
- Informed Consent Communication - Download zip file (48 MB)
- Confidentiality and Privacy - Download zip file (41 MB)
- Participant Safety and Adverse Event Reporting - Download zip file (33 MB)
- Quality Control and Assurance - Download zip file (38 MB)
- Research Misconduct - Download zip file (28 MB)
- Community and Stakeholder Engagement - Download zip file (29 MB)
- Conclusion/Wrap-up - Download zip file (11 MB)
