The International Committee of Medical Journal Editors (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 cause-and-effect 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, behavioural 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 FDA defines an Applicable Clinical Trial (ACT) as follows:Trials of drugs and biologics: controlled clinical investigations, other than Phase 1 investigations, of a product subject to FDA regulation.· Trials of biomedical devices: controlled trials with health outcomes of devices subject to FDA regulation, other than small feasibility studies, and pediatric post-market surveillance.· For complete statutory definitions and more information on the meaning of Applicable Clinical Trial, see Elaboration of Definitions of Responsible Party and Applicable Clinical Trial (PDF). |
The trial may be “Qualifying” if it:
-OR- Your trial (All three criteria must be "Yes"):
For additional information regarding “Qualifying Trials” please refer to Qualifying Clinical Trials on the HUB. |
The clinical trials number to be reported is the number assigned by the National Library of Medicine (NLM) http://clinicaltrials.gov website (an 8-digit # preceded by “NCT”, a.k.a. “the NCT #”) when a study appears in the NLM Clinical Trials database. |
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Unregistered trials will not be considered for publication in journals that adhere to ICMJE standards. This penalty has not changed over time. According to the FDA/NIH (Food and Drug Amendments Act of 2007): Penalties may include civil monetary penalties up to $10,000 fine for failing to submit or for submitting fraudulent information to ClinicalTrials.gov. After notification of noncompliance, the fine may go up to $10,000 per day until resolved. For federally funded grants, penalties may include the withholding or recovery of grant funds. |
Detailed definitions can be found in the Elaboration of Definitions of Responsible Party and Applicable Clinical Trials document. In general, a study is likely subject to the requirements of FDAAA if YES is answered to all five questions below:
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Additional information can be found in the Elaboration of Definitions of Responsible Party and Applicable Clinical Trials document. |
Generally speaking, the regulatory sponsor of an ACT will register and report the results of the trial if they:
Generally speaking, Principal Investigators of applicable clinical trials will register and report the results of the trial if:
For ACTs where there is no IND or IDE holder, the funding recipient is generally the responsible party. Note: For investigator-initiated ACTs, where a UCSF PI holds the IND/IDE, the IND/IDE holder must serve as the responsible party. |
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