Investigator Information

Register Clinical Trials

• Frequently Asked Questions about the FDA / NIH / ICMJE Requirements

Clinical Trial Registration Resources

• For more information about the FDA Amendments Act of 2007, see:
  • Guidance from the NIH Office of Extramural Research
  • PRS and U.S. Public Law 110-85
• For more information about the International Committee of Medical Journal Editors (ICMJE) registration requirements, see:
  • The 2007 ICMJE editorial titled “Clinical Trials Registration: Looking Back and Moving Ahead.” (PDF)
• For more information about publication in the Journal of the American Medical Association (JAMA), see:
  • JAMA article (PDF)

ClinicalTrials.gov Results Registration System (RRS) Resources

• For more information, visit the Results Registration System page
• To receive notification of future draft FDAAA 801 documents, join the NIH FDAAA Update LISTSERV
• An early mock-up of the interactive web-based ClinicalTrials.gov Results Registration System and background materials are available for review on the Results Data Entry Mockup page

NIH Public Access Policy Resources

• NIH Public Access Summary
• NIH Public Access
• Revised Policy on Enhancing Public Access to Archived Publications Resulting from NIH-Funded Research
• PubMed Central
• NIH Manuscript Submission System
• Tutorials
• PubMed Central Demo