NIH Releases Final Rule Governing Mandatory Clinical Trial Registration and Reporting

On Friday, September 16, 2016 the U.S. Department of Health and Human Services (HHS) released the much anticipated Final Rule for clinical trial registration and reporting.  42 CFR Part 11, Clinical Trials Registration and Results Information Submission; Final Rule was added to the Federal Register on Wednesday, September 21, 2016 and will take effect on  January 18, 2017.  A brief summary was also released.

The Johns Hopkins Institute for Clinical and Translational Research (ICTR) is committed to the ethical conduct and transparency of research throughout the Institution.  The ClinicalTrials.gov Program, launched earlier this year, has been preparing Principal Investigators and Study teams to identify and update clinical trials sponsored by Johns Hopkins University.  Final-rule specific training is being developed and will be made available in the coming months.

Through partnership with national collaborators and leadership at the National Institutes of Health (NIH) we are well-positioned to fully implement the Changes from Current Practice Described in the Final Rule.

The link below features an informative News Release, additional information and a video by Dr. Francis Collins, NIH Director.

https://www.nih.gov/news-events/news-releases/hhs-take-steps-provide-more-information-about-clinical-trials-public

Questions can be directed to Nidhi Atri, MD, Program Administrator at registerclinicaltrial@jhmi.edu