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.
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 35 MB
Module 2: Research Protocol - Download zip file 111 MB
Module 3: Recruitment and Retention - Download zip file 102 MB
Module 4: Informed Consent Communication - Download zip file 181 MB
Module 5: Confidentiality and Privacy - Download zip file 76 MB
Module 6: Participant Safety and AE Reporting - Download zip file 101 MB
Module 7: Quality Control and Assurance - Download zip file 112 MB
Module 8: Research Misconduct - Download zip file 141 MB
Module 9: Conclusion/wrap-up - Download zip file 18 MB