Clinical Trials
- Guide Notice for Clinical Trial Protocol Template for Phase 2 and 3 IND/IDE Studies
- Comment Form for Clinical Trial Protocol Template
- Protocol Template: Instructional and Sample Text document (pdf)
- Protocol Template Shell (Headers only, no instructional and sample text) (doc)
- OSP “Under the Poliscope” Blog on Protocol Template
- "FDA Voiceā€¯ Blog on Protocol Template
DHHS Final Rule for Clinical Trials Registration and Results Information Submission
- Federal Register Notice of Final Rule for Clinical Trials Registration and Results Submission
- NPRM Clinical Trials Registration and Results Submission (November 2014)
Final NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information
Draft NIH Policy on Dissemination of NIH-Funded Clinical Trial Information
Additional Resources
- Summary of the Final Rule and NIH Policy
- Key Elements of Final Rule and NIH Policy
- Summary Table of Changes from Current Practice Described in the Final Rule
- OSP-OER Blog "Improving Visibility of NIH-Supported Clinical Trial Activities and Results Information"
- OSP-OER Blog "Building Better Clinical Trials through Enhanced Stewardship and Transparency"
- JAMA Article "Toward a New ERA of Trust and Transparency in Clinical Trials"
- NEJM Article "The Final Rule of U.S Clinical Trials Registration and Results Information Submission"
- NIH Workshop on the Enrollment and Retention of Participants in NIH-funded Clinical Trials July 25, 2014
- Resources