The Food and Drug Administration Amendments Act of 2007 (FDAAA or US Public Law 110-85)
was passed on September 27, 2007. The law requires mandatory registration and results reporting for certain interventional clinical trials. Applicable clinical trials utilize drugs, biologics, and/or devices for serious or life-threatening diseases or conditions that may be subject to FDA regulation under an investigational new drug application (IND) or investigational device exemption (IDE).
As of August 18, 2011, ClinicalTrials.gov requires sponsor investigators deemed the Responsible Party to review final protocol records and release them into the protocol registration system, ensuring that the posted trial on ClinicalTrials.gov is updated with the correct information. A sponsor investigator is defined as the individual who initiates and conducts the study, has access to and control over the data, and the right to publish the results of the trial
This new requirement means that Principal Investigators of investigator-initiated protocols registered in the system must have a clinicaltrials.gov account and be listed as the Responsible Party. Designated staff may continue to update and edit protocol records, but now only the Principal Investigator has the ability to release these records.
Please note that protocol records must be updated every six months for active trials and final results must be entered within 12 months of the actual primary completion date of the protocol if it qualifies per U.S. Public Law 110-85 FDAAA requirements. Failure to comply with this regulation may result in significant penalties to the Principal Investigator.