The Department of Health and Human Services and National Institutes of Health have issued a final rule and companion policy, respectively, providing more information about clinical trials to the public in an effort at increased transparency.

The HHS final rule, which takes effect on Jan. 18, 2017, expands the legal requirements for submitting registration and results information for clinical trials involving Food and Drug Administration-regulated drug, biological and device products, including adverse event information. However, the requirements do not apply to Phase 1 trials of drug and biological products or small feasibility studies of device products.

Register or login for access to this item and much more

All Health Data Management content is archived after seven days.

Community members receive:
  • All recent and archived articles
  • Conference offers and updates
  • A full menu of enewsletter options
  • Web seminars, white papers, ebooks

Don't have an account? Register for Free Unlimited Access