• 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 Voice” 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

• Federal Register Notice for NIH Policy on the Dissemination of NIH-Funded Clinical Trials

• NIH Guide Notice

Draft NIH Policy on Dissemination of NIH-Funded Clinical Trial Information

• FR Notice

• NIH Guide Notice

• Compendium of Comments

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"