New Requirements

Final Rule Update:  New Regulations and policy for NIH-Funded Trials and Applicable Clinical Trials required by FDAAA

New regulations by the U.S. Department of Health and Human Services (HHS) and policy by the National Institutes of Health (NIH) are in effect to further increase transparency and publication of clinical trial information in in a timely manner.

The Final Rule for Clinical Trials Registration and Results Information Submission (released in September 2016) became effective January 18, 2017. Note, corrections to any apparent errors, deficiencies, and/or queries are now required within 15 calendar days for registration information and 25 calendar days for results information.

Additionally, The NIH Policy on the dissemination of NIH-funded clinical trial information complements the Final Rule in that the NIH Policy requires that all clinical trials funded in whole or in part by NIH (regardless of study phase, type of intervention, or whether they are subject to the Final Rule) be registered on and summary of results data submitted and posted in a timely manner. 

Failure to comply with the updated regulation may have legal consequences, which are described in the Final Rule. In addition, non-compliance and failure to submit all required registration and results information can jeopardize grant funding and future funding to the grantee and/or institution.

Coming Soon

June 2017 (estimated) – the protocol and statistical analysis plan must be submitted to the PRS as part of the submission of results data reporting for a study with a Primary Completion Date on or after January 18, 2017 but before the PRS modification. Note: This mechanism for submitting protocols and SAPs will also accommodate the optional submission of informed consent documents. 

Source: The Children's Hospital of Philadelphia Research Institute's Office of Research Compliance (ORC)