Helpful Resources

 

• FAQs (ClinicalTrials.gov)
• PRS User's Guide (ClinicalTrials.gov)
• How to Register Your Study
• How to Edit Your Study Record
• How to Submit Your Results
• Protocol Registration Data Element Definitions
• The Final Rule, DHHS: https://www.federalregister.gov/clinical-trials-registration-and-results-information-submission
• The Final Rule, Webinar Series (3):
• Final Rule Webinar 1
• Final Rule Webinar 2
• Final Rule Webinar 3
• Overview of ClinicalTrials.gov and Related Policies: https://prsinfo.clinicaltrials.gov/webinars/module1/index.html
• Key FDAAA Issues: https://prsinfo.clinicaltrials.gov/webinars/module2/index.html
• Clinical Trial Policies (PDF)
• CITI Training for ClinicalTrials.gov
• Does your human subject research meet the NIH definition?
• Requirements for registering and reporting NIH funded clinical trials on ClinicalTrials.gov
• NIH Training and Resources