Clinical Research
NIH Clinical Research Policies
- NIH Policy for Data and Safety Monitoring (NOT-98-084)
- Further Guidance on Data and Safety Monitoring for Phase I and Phase II Trials (NOT-00-038)
- Guidance on Changes That Involve Human Subjects in Active Awards and That Will Require Prior NIH Approval (NOT-12-129)
- Prior NIH Approval of Human Subjects Research in Active Awards Initially Submitted without Definitive Plans for Human Subjects Involvement (Delayed Onset Awards) (NOT-12-130)
- Training in Human Subject Research
NIMH Clinical Research Policies
- Policy Governing the Monitoring of Clinical Trials
- Reportable Events Policy
- NIMH Recruitment of Participants in Clinical Research Policy
- Policy Governing Independent Safety Monitors and Independent Data and Safety Monitoring Boards
NIMH Clinical Research Guidance
- Conducting Research with Participants at Elevated Risk for Suicide: Considerations for Researchers
- NIMH Guidance on Risk-Based Monitoring
- Guidance for Developing a Data and Safety Monitoring Plan
- Enhancing the Reliability of NIMH-Supported Research through Rigorous Study Design and Reporting
- Human Subjects Research Issues
Research Resources
- NIH OER Clinical Trial Requirements for Grants and Contracts
- NIMH Clinical Trials: Portfolio, Progress to Date, and the Road Forward
- Research Involving Human Subjects
- Ethical Guidelines & Regulations
- NIH Human Subjects Policies and Guidance
- NIH Human Subjects Protections Training
- Certificates of Confidentiality
- Financial Conflict of Interest
- Revised NIH Definition of “Clinical Trial” (NOT-15-015)
- ClinicalTrials.gov
- Register a study with ClinicalTrials.gov
- NIH Toolbox
- NIMH Educational Materials and Publications for Clinical Research Participants
- NIMH Practical Clinical Trials
- NLM
- Common Data Elements for NIMH-sponsored clinical trials
- PROMIS (offers patient-reported outcome item banks for research)
- UCSF Center for AIDS Prevention Studies - Research Assessments
- Webinars:
Data Resources for Clinical Research
NIMH Data Archives:
- National Database for Clinical Trials (NDCT)
- Including Limited Access Datasets from NIMH-Supported Clinical Trials
- National Database for Autism Research(NDAR)
- Research Domain Criteria Database (RDoCdb)
- NIH Pediatric MRI Data Repository (PedsMRI)
- National Survey on Drug Use and Health (NSDUH) Series