Good Clinical Practice (GCP) Online Course
FREE Online Course with Certificate
Course are based on ICH GCP Principles and the Code of Federal Regulations (CFR) for clinical research trials in the U.S.
The course is self-paced and takes approximately six hours to complete.
TO BEGIN THE ONLINE COURSE, CLICK HERE TO REGISTER
There are 12 modules, with content covering many aspects of research trials, for example, informed consent processes, assessing safety of participants, and provision of primary oversight of the study staff’s conduct. In addition to the general aspects of research trials, the NIDA CCTN CTN has incorporated content on confidentiality and protections of study participants enrolled in substance use trials. The material is based on US CFR, International GCP guidelines, and human subject protection requirements for conducting clinical research.
While this program is available to study staff participating in the NIDA Clinical Trials Network, the training is open-access to the public. Trainees are required to complete a quiz following each module, except for the Introduction module. To receive a certificate, all quizzes must be completed with at least 80% accuracy. Upon successful completion of all quizzes, the user will be given access to the link for the Certificate of Completion, which has an expiration date three years after the date of completion. NIDA CCTN CTN members complete the training in compliance with network policies and procedures. Users external to the NIDA CCTN CTN, international and domestic, complete the training per their own institutional, affiliate, and research advisory requirements.
2. Institutional Review Boards
3. Informed Consent
4. Confidentiality & Privacy
5. Participant Safety & Adverse Events
6. Quality Assurance
7. The Research Protocol
8. Documentation & Record-Keeping
9. Research Misconduct
10. Roles & Responsibilities
11. Recruitment & Retention
12. Investigational New Drugs
Users are required to complete a quiz following each module, except for the Introduction module. To receive a certificate, all quizzes must be completed with at least 80% accuracy.
Upon successful completion of all quizzes, the user will be given access to the Certificate of Completion. Within the NIDA Clinical Trials Network, certification expires after three years.
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