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 http://clinicaltrials.gov/results_definitions.html
  3. 10 minute webinars for each results module http://gov/ct2/manage-recs/present
  4. Helpful Hints (with common study designs examples) http://clinicaltrials.gov/ResultsExamples.pdf
  5. ACT Wizard: http://grants.nih.gov/clinicaltrials_fdaaa/docs/Flow_chart-ACT_only.pdf
  6. gov history: https://www.clinicaltrials.gov/ct2/about-site/history
  7. gov homepage: https://www.clinicaltrials.gov/
  8. gov FAQ: https://clinicaltrials.gov/ct2/manage-recs/faq
  9. NIH Guidance on FDAAA:
  10. http://nih.gov/grants/guide/notice-files/NOT-OD-08-014.html
  11. FDA Guidance on Form FDA 3674:
  12. http://fda.gov/RegulatoryInformation/Guidances/ucm125335.htm
  13. Elaboration of Definitions of Responsible Party and Applicable Clinical Trial https://clinicaltrials.gov/ElaborationsOnDefinitions.pdf