The learning modules below will provide clinical research teams with general information about clinical trials. Each module will have a list of objectives, required content (e.g., series of audio slides, links to YouTube videos), recommended content (i.e., readings, videos), list of resources, and a link to the evaluation.

All module content is consistent with U. S. Federal Regulations and Good Clinical Practice (GCP). 

Clinical Trial Topic
Good Clinical Practice & Human Subjects Protection
Clinical Trial Design
Protocol Development, Review and Approval  
Responsibilities of the Research Team
Informed Consent 
Documentation and Document Management 
Adverse Events
Clinical Data Management
Clinical Trial Monitoring and Auditing
Drug Development: FDA and Sponsor Responsibilities of IND Trials 

Once you have viewed each of the module content,  you will be asked to complete a short evaluation. After completing the evaluation, you will be redirected to a certificate of completion for your education record. If at any time the evaluation link doesn't take you to the evaluation but rather the certificate of completion, please copy the url, paste into your browser, and complete the evaluation.

I hope you find the information helpful.

Thank you,
Elizabeth Ness, MS, BSN, RN
Director, Office of Education and Compliance
Center for Cancer Research, National Cancer Institute
email: nesse@mail.nih.gov 
phone: 240-858-3747 
Last updated by Kirby, Tracy (NIH/NCI) [E] on Feb 05, 2021