This site provides, HHS and NIH requirements and resources for the extramural community involved in human subjects research in their roles as: Applicants/Grantees, Offerors/Contractors, Peer Reviewers, Institutional Officials.
HHS and NIH take steps to Enhance Transparency of Clinical Trial Results
November 24, 2014
The U.S. Department of Health and Human Services has issued a Notice of Proposed Rulemaking (NPRM), which proposes regulations to implement reporting requirements for clinical trials that are subject to Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA).
You can read a summary of the proposed changes : http://www.nih.gov/news/health/nov2014/od-19_summary.htm.
NOT-OD-15-015 Notice of Revised NIH Definition of Clinical Trial
October 29, 2014
NOT-OD-15-015 The revised definition clarifies the distinction between clinical trials and clinical research studies and is designed to enhance the precision of the information NIH collects, tracks, and reports on clinical trials.