Applicable Clinical Trial (ACT)
Applicable Clinical Trial (ACT) is the term used in Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA) (PL 110-85) to designate the scope of trials that may be subject to the registration and reporting requirements in FDAAA. FDAAA defines the term using two other terms defined in the Act, namely an “applicable drug clinical trial” or an “applicable device clinical trial”.1)
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:
- Was the study initiated after September 27, 2007 (OR ongoing as of December 26, 2007)?
- Is the study ‘interventional’ (i.e., participants are assigned to interventions by protocol)?
- Does the study evaluate a ‘drug’, ‘biological product’, or ‘medical device’ (whether or not approved for marketing in the United States)?
- Is the study not considered a phase I clinical investigation (e.g., a phase 2 study) OR not considered a ‘small feasibility’ device trial (e.g., a pivotal study)?
- Does the study have at least one site located in the United States OR is the study conducted under an IND or IDE?