ClinicalTrials.gov Resources
Clinical Research Brown Bags
- December 7, 13 and 16, 2016: Final Rule and NIH Policy on Trial Registration
- May 29, 2019: Submitting Results Information on ClinicalTrials.gov
Clinical Research Newsletters
- Volume 4 Issue 1 - ClinicalTrials.gov
- Volume 5 Issue 4 - Final Rule and NIH Policy (ClinicalTrials.gov - What's New)
- Volume 8 Issue 2 - Submitting Results on ClinicalTrials.gov
- Volume 10 Issue 1 - Updates to ClinicalTrials.gov
- Trial Reporting in ClinicalTrials.gov - The Final Rule (Zarin, D. et al., 2016 in NEJM)
- For the First Time, the FDA Warns a Trial Investigator for Failing to Report Study Results (Silverman, E., 2021 in STAT)
- Approach for Reporting Master Protocol Study Designs on ClinicalTrials.gov: Qualitative Analysis (Williams, R. et al., 2022 in BMJ)
- Applicable Clinical Trial (ACT) Checklist
- PRS User Guide
- PRS Guided Tutorials
- PRS Help on Protocol Data Entry (must be logged into PRS before clicking)
- PRS Help on Study Document Submission
- PRS Help on Results Data Entry (must be logged into PRS before clicking)
- What's New in PRS
- PRS FAQs
- Summary Table comparing FDAAA/Final Rule, NIH and ICMJE requirements
- Notices of Noncompliance and Civil Money Penalty Actions
- FDA's Center for Drug Evaluation and Research (CDER) Webinar Series (on YouTube):
- ClinicalTrials.gov Part 1: Meeting Transparency and Reporting Requirements
- ClinicalTrials.gov Part 2: Definitions, Laws and Regulations
- ClinicalTrials.gov Part 3: CDER's Compliance and Enforcement Activities