Page 340 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

FDAAA 801, The Final Rule (42 CFR Part 11), and ClinicalTrials.Gov Registration
treatments, dietary interventions, and process-of-care changes) to evaluate the effects on health outcome
In general, your study is a clinical trial if you answer “Yes to all of these questions:
− Does the study involve human participants?
− Are the participants prospectively assigned to an intervention?
− Is the study designed to evaluate the effect of the intervention on the
participants?
− Is the effect being evaluated a health-related biomedical or behavioral
outcome?
Pediatric post-market surveillance of FDA regulated device product (which does not meet the definition of clinical trials) require registration and result reporting.
E. What is an applicable clinical trial (ACT)?
This final rule details the requirements for submitting registration and summary results information, including adverse event information, for specified clinical trials of drug products (including biological products) and device products and for pediatric post-market surveillances of a device product to ClinicalTrials.gov, the clinical trial registry and results data bank operated by the National Library of Medicine (NLM) of the National Institutes of Health (NIH).
The requirements apply to the responsible party (meaning the sponsor or designated principal investigator) for certain clinical trials of drug products (including biological products) and device products that are regulated by the Food and Drug Administration (FDA) and for pediatric post-market surveillances of a device product that are ordered by FDA.
This final rule does not impose requirements on the design or conduct of clinical trials or on the data that must be collected during clinical trials. Instead it specifies how data that were collected and analyzed in accordance with a clinical trial's protocol are submitted to ClinicalTrials.gov. No patient-specific data are required to be submitted by this rule or by the law this rule is intended to implement.
The Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11) states that a checklist-based tool will 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).