The data must be shared broadly and quickly. The Final Rule clarifies the law previously mandated in September 2000.
All Clinical Trials that are determined to be "Applicable Clinical Trials" (ACT), as defined by the FDA. These are covered by the FDA's Final Rule. In addition, this applies to all NIH Funded Clinical Trials, except for infrastructure grants and trials that were completed prior to January 18, 2017. If the study ends prior to January 18th, 2017, you should enter basic information about the study, but you are not required to submit results. If the study is completing after January 18th, 2017, you must and are required to do the reporting.
To determine if a trial is an "Applicable Clinical Trial" (ACT) for those trials other than NIH, please see the checklist on our website or by following the link here: https://prsinfo.clinicaltrials.gov/ACT_Checklist.pdf
A Responsible Party is determined by the criteria below. In the case of Cooperative Agreements, the PI and study team must agree ahead of time who will be the responsible party. It will not be the NIH.
There are new registration data elements. These data elements are required when registering the trial and you can find them here: https://prsinfo.clinicaltrials.gov/definitions.html. On the next page, you will find links to registering a clinical trial on the clinicaltrials.gov website. Generally, if not a drug or device study, it would be excluded. However, vitamins, etc. are to be included under this rule. When in doubt – register!
Institutions are required to implement no later than April 18, 2017.
Sharon Levine-Sealy, Director of Pre-Award Operations
Elliot Feder, Director, Post-Award Research Administration
Kevin L. Nellis, MS, CIP, Executive Director
Human Research Protection & Quality Assurance
ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world.
Clinical Trials and Human Subject Protection at the U.S. Food and Drug Administration.
NIH Clinical Research Trials and You – National Institutes of Health (NIH)