The electronic protocol writing tool aims to facilitate the development of phase 2 and 3 clinical trial protocols that require a Food and Drug Administration (FDA) Investigational New Drug (IND) or Investigational Device Exemption (IDE) Application. The development of the Phase 2 and 3 clinical trial protocol template was an initiative supported by the NIH-FDA Joint Leadership Council and the NIH Clinical Trial Stewardship Reform Task Force, and meets the standards outlined in the International Conference on Harmonisation (ICH) Guidance for Industry, E6 Good Clinical Practice: Consolidated Guidance (ICH-E6). Questions about the tool can be sent to SciencePolicy@od.nih.gov.
Final Template Documents
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
Draft NIH Policy on Dissemination of NIH-Funded Clinical Trial Information
- 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