The Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11) stated 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 (ACT) as defined in in 42 CFR 11.10(a) 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).
The Checklist and Elaboration for Evaluating Whether a Clinical Trial or Study is an Applicable Clinical Trial (PDF) document follows the criteria specified in 42 CFR 11.22(b), as explained further in the preamble, to determine whether a study initiated on or after January 18, 2017, is an ACT subject to "expanded" registration requirements under the final rule.
Beyond their primary purpose, the ACT Checklist and Elaboration may also be useful to assist in evaluating whether a clinical trial or study that was initiated before January 18, 2017, and which is not subject to the final rule requirements, is an ACT under section 402(j) of the Public Health Service Act.
We note that Responsible Parties or other users of the ACT Checklist and Elaboration are responsible for using accurate data about a clinical trial or study and for properly evaluating whether the trial or study must be registered and, if so, which results must be submitted. The outcome generated from the ACT Checklist 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 action(s).