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|
|Documentation and Document Management|
|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.
Elizabeth Ness, MS, BSN, RN
Director, Office of Education and Compliance
Center for Cancer Research, National Cancer Institute