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STANDARD OPERATING PROCEDURE Research Administration SOP No: Q021
SOP Title: FDAAA 801, The Final Rule (42 CFR Part 11), and ClinicalTrials.Gov Registration
not apply to clinical trials in ongoing, non-competing awards, but that it will apply if the grantee submits a competing renewal application that includes a new clinical trial, i.e., a clinical trial initiated on or after the effective date of the policy. For the intramural program, the policy applies to clinical trials initiated on or after the policy's effective date. The policy's effective date is January 18, 2017. The policy clarifies that a clinical trial that uses NIH-supported infrastructure but does not receive NIH funds to support its conduct, is not subject to the policy.
Although the policy does not apply to NIH-funded clinical trials initiated before the effective date, we encourage all ongoing NIH-funded clinical trials to follow it. It is also critical for investigators conducting NIH-funded applicable clinical trials that are subject to the statute and rule to be sure they are in compliance with those requirements.
C. InternationalCommitteeofMedicalJournalEditors(ICMJE)
The ICMJE defines a clinical trial as any research project that prospectively assigns people or a group of people to an intervention, with or without concurrent comparison or control groups, to study the relationship between a health-related intervention and a health outcome. Health-related interventions are those used to modify a biomedical or health-related outcome; examples include drugs, surgical procedures, devices, behavioral treatments, educational programs, dietary interventions, quality improvement interventions, and process-of-care changes. Health outcomes are any biomedical or health- related measures obtained in patients or participants, including pharmacokinetic measures and adverse events. The ICMJE does not define the timing of first participant enrollment, but best practice dictates registration by the time of first participant consent.
The ICMJE’s clinical trial registration policy is detailed in a series of editorials (see Updates and Editorials and FAQs). ICMJE requires, and recommends that all medical journal editors require, registration of clinical trials in a public trials registry at or before the time of first patient enrolment as a condition of consideration for publication. Editors requesting inclusion of their journal on the ICMJE website list of publications that follow ICMJE guidance should recognize that the listing implies enforcement by the journal of ICMJE’s trial registration policy.
The ICMJE accepts publicly accessible registration in any registry that is a primary register of the WHO International Clinical Trials Registry Platform (ICTRP) that includes the minimum acceptable 24-item trial registration dataset or in ClinicalTrials.gov, which is a data provider to the WHO ICTRP. The ICMJE endorses these registries because they meet several criteria. They are accessible to the public at no charge, open to all prospective registrants,
SOP No. 24, 07-14-2020, 05-31-2022