Additional Submission of Clinical Trial Information

  1. Law
  2. CFR 42
  3. Public Health
  4. Public Health Service, Department of Health and Human Services
  5. General Provisions
  6. Clinical Trials Registration and Results Information Submission
  7. Additional Submission of Clinical Trial Information

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Section
11.60

What requirements apply to the voluntary submission of clinical trial information for clinical trials of FDA-regulated drug products (including biological products) and device products?

Section
11.62

What requirements apply to applicable clinical trials for which submission of clinical trial information has been determined by the Director to be necessary to protect the public health?

Section
11.64

When must clinical trial information submitted to ClinicalTrials.gov be updated or corrected?