Resources
Federal Regulations
- Clinical Trials Registration and Results Information Submission (Final Rule)
- Final Rule (42 CFR Part 11) Information
- NIH Elaboration Document of Responsible and Applicable Clinical Trial
- NIH Policy & Compliance ClinicalTrials.gov and FDAAA: FAQs
- ClinicalTrials.gov
- 2018 Common Rule
- 2018 Common Rule – Clinical Trial Informed Consent Form Posting
- ICMJE FAQ