The regulations in 42 CFR 11.60 identify two types of clinical trials for which the submission of clinical trial information is considered voluntary:
Clinical trials of U.S. Food and Drug Administration (FDA)-regulated drug, biological, or device products that are not applicable clinical trials (ACTs) (referred to here as “non-ACT voluntary submissions”)
ACTs that were initiated on or before September 27, 2007, and that reached their primary completion date before December 26, 2007 (referred to here as “pre-FDAAA ACT voluntary submissions”)
For both types, the regulations refer specifically to “clinical trials”, thereby excluding the submission of information for observational studies from being considered voluntary submissions. In addition, because the Food and Drug Administration Amendments Act of 2007 (FDAAA) became law on September 27, 2007, only certain clinical trials for which clinical trial information was submitted on or after September 27, 2007, can be considered a voluntary submission.
Non-ACT Voluntary Submission
The first type of voluntary submission described in 42 CFR 11.60, a non-ACT voluntary submission, is a clinical trial of an FDA-regulated drug, biological, or device product that is not an ACT (see 42 CFR 11.60(a)(1)(i), 42 CFR 11.60(b)(1)(i), and 42 CFR 11.60(c)(1)(i)). The submission of a phase 1 trial of an FDA-regulated drug or biological product or a small clinical trial that evaluates the feasibility of an FDA-regulated device product is a non-ACT voluntary submission. The submission of a trial that studies only a behavioral (or other) intervention that is not an FDA-regulated drug, biological, or device product is not a voluntary submission (81 FR 65105). Therefore, submission of registration and/or results information for a clinical trial of an FDA-regulated product that would not otherwise meet the ACT definition as described in 42 CFR 11.10(a) or 11.22(b) would be considered a voluntary submission under 42 CFR 11.60. This means that non-ACT voluntary submissions would be identified based on the data elements specified in 42 CFR 11.28 (when provided) and outlined below:
The Study Type is “Interventional”.
At least one of the following applies:
- At least one Facility Location — Country is “United States” or a U.S. territory.
- The response to U.S. Food and Drug Administration IND or IDE? is “Yes.”
- The response to Product Manufactured in and Exported from the U.S.? is “Yes.”
- The response to Studies a U.S. FDA-regulated Drug Product? is “”Yes,”” and/or the response to Studies a U.S.
- FDA-regulated Device Product? is “Yes.”
- The Study Phase is “Early Phase 1” or “Phase 1” (for drug or biological products), or the Primary Purpose is “Device Feasibility” (for device products).
- Pre-FDAAA ACT Voluntary Submission.
The second type of voluntary submission described in 42 CFR 11.60, a pre-FDAAA ACT voluntary submission, is a clinical trial that meets all the ACT criteria found in 42 CFR 11.10(a) and 11.22(b) but for which submission of clinical trial registration information is not required because the trial was initiated on or before September 27, 2007, and reached its primary completion date before December 26, 2007 (see 42 CFR 11.60(a)(1)(ii), 42 CFR 11.60(b)(1)(ii), and 42 CFR 11.60(c)(1)(ii)). As noted previously, for such pre-FDAAA ACT voluntary submissions, information about the trial must have been submitted on or after September 27, 2007.
