CCTR Seminar: New NIH Clinical Trial Requirements 1/12/18
Location: Egleston Classrooms 5-7
The NIH has been implementing a series of policy requirements designed to strengthen stewardship of public resources, scientific rigor, transparency, ethical oversight, and accountability. This past year, there have been new requirements for training in good clinical practice (GCP), ClinicalTrials.gov, and Certificates of Confidentiality. There are more policy requirements planned for January 2018, including a new mechanism for submitting NIH applications involving clinical trials and the use of single IRBs.
1) Determine if your study meets the NIH definition of a clinical trial & the implications of that determination.
2) Determine what NIH Funding Opportunities allow clinical trials & understand the new required paperwork for submission.
3) Determine who needs Good Clinical Practice training and how often.
4) Determine what studies will be required to use a single IRB and what is entailed.
5) Determine what studies are automatically covered under a Certificate of Confidentiality.
6) Determine what studies require ClinicalTrials.gov registration & reporting, & the penalties for noncompliance.