In September 2016, the NIH issued a Policy on Good Clinical Practice (GCP) Training for NIH Awardees Involved in NIH-funded Clinical Trials. GCP is an international ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials. The principles of GCP help assure the safety, integrity, and quality of clinical trials. Investigators and clinical trial staff who are competent in GCP principles will be better able to assure that the rights, safety, and well-being of human subjects are protected; that clinical trials are conducted in accordance with approved plans and with rigor and integrity; and that data derived from clinical trials are reliable.

Instructions for downloading and uploading the modules to your Learning Management System (LMS) (477 KB)

The LMS should create a certificate of completion (to print or save) for the learner upon successful completion of the modules. Successful completion requires the learner to work through all nine modules and successfully complete the knowledge tests and exercises along the way. The course is designed to track progress within your Institution’s LMS.

Module 1: Introduction - Download zip file 26 MB
Module 2: Research Protocol - Download zip file 27 MB
Module 3: Recruitment and Retention - Download zip file 25 MB
Module 4: Informed Consent Communication - Download zip file 48 MB
Module 5: Confidentiality and Privacy - Download zip file 41 MB
Module 6: Participant Safety and Adverse Event Reporting - Download zip file 33 MB
Module 7: Quality Control and Assurance - Download zip file 38 MB
Module 8: Research Misconduct - Download zip file 28 MB
Module 9: Community and Stakeholder Engagement - Download zip file 29 MB
Module 10: Conclusion/Wrap-up - Download zip file 11 MB