Clinical Trials Overview
Before You Begin an Application
- NIH Clinical Trials Definition
- Understand Clinical Trials Changes at the NIH
- Contact NIDCD
- Know What Funding Opportunities Are Available
- Acceptance Requirement for Applications with $500,000 or More in Annual Direct Costs
Preparing Your NIDCD Application
- Apply Early and Choose the Appropriate FOA
- Documentation for Verifying Device Clinical Trials Not Requiring an Investigational Device Exemption (IDE) Application
- Considerations in Constructing Clinical Trial Budgets
- Review Criteria for Applications with Clinical Trials
- Human Subjects and Clinical Trials Information Form
- NIDCD Guidelines for Data and Safety Monitoring of Clinical Trials
- Suggested Questions for Data and Safety Monitoring Board Review of a Funded and Scientifically Reviewed Protocol
- Single IRB Plan (sIRB) for Multi-Site Research
If Funded – Clinical Trials Requirements
- Steps Prior to the Implementation of NIDCD U01 Clinical Trials
- Good Clinical Practice Training
- Clinical Trials e-Protocol Template/Tool
- ClinicalTrials.gov Registration
Observational Studies
- NIDCD Guidelines for Data Monitoring and Oversight of Observational Studies
- Conflict of Interest Certification Form: Data Monitoring and Oversight of Observational Studies Committee (34KB PDF)
Note: PDF files can be viewed with the free Adobe Reader.
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