Helpful Links

NIH Final Rule September 16, 2016

  1. Federal Register Notice: HHS Final Rule
  2. Federal Register Vol. 81, No 183, September 21, 2016
  3. Federal Register Notice: NIH Policy
  4. Summary Table: HHS Final Rule and NIH Policy
  5. Summary of Changes: HHS Final Rule and NIH Policy
  6. JAMA: Toward a New Era of Trust and Transparency in Clinical Trials
  7. NEJM: The Final Rule for US Clinical Trial Registration and Results Information Submission
  8. NIH Director’s Blog: Clinical Trials – Sharing of Data and Living Up to Our End of the Bargain
  9. NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information

The links below provide additional information.

  1. How to Submit Your Results homepage http://gov/ct2/manage-recs/how-report
  2. Basic Results Data Elements Definitions
  3. 10 minute webinars for each results module http://gov/ct2/manage-recs/present
  4. Helpful Hints (with common study designs examples)
  5. ACT Wizard:
  6. history:
  7. homepage:
  8. FAQ:
  9. NIH Guidance on FDAAA:
  10. FDA Guidance on Form FDA 3674:
  11. Elaboration of Definitions of Responsible Party and Applicable Clinical Trial:
  12. HHS takes steps to provide more information about clinical trials to the public