The Final Rule for Clinical Trials Registration and Results Submission (42 CFR Part 11) indicated that a checklist-based tool would be available to assist responsible parties in evaluating whether their clinical trial or study is an applicable clinical trial based on the conditions outlined in 42 CFR 11.22(b) (Determination of applicable clinical trial for a clinical trial or study initiated on or after January 18, 2017). This checklist and an accompanying elaboration that provides additional information from the final rule for answering the questions in the checklist, are now available at: https://prsinfo.clinicaltrials.gov.
We note that this checklist does not require access to the ClinicalTrials.gov Protocol Registration and Results System (PRS) and is separate from the registration process. Responsible parties or other users of the checklist are responsible for using accurate data about a clinical trial or study and for conducting the evaluation. The outcome generated by the checklist tool will not be retained by the National Institutes of Health (NIH) and will not be binding on either the user or any government agency in any future actions.
This checklist is also available on ClinicalTrials.gov Support Materials page at https://clinicaltrials.gov/ct2/manage-recs/resources#FDAAA2007.