Over the last six to eight months, the FDA’s activity regarding compliance with the required posting of ongoing and completed clinical trials has significantly increased, as evidenced by the issuance of multiple warning letters and letters of non-compliance to sponsors and/or principal investigators.
To assist responsible parties in complying with the requirement to post on ClinicalTrials.gov, the FDA has announced three live Small Business and Industry Assistance (SBIA) panel discussions on “ClinicalTrials.gov: Essentials for Academic Medical Centers” to be held on July 14th. Registration for the live panels can be found here. The “training begins with a required, pre-recorded video that you can complete at your own pace prior to registering for any or all of the live panel sessions.”
The training session runs for thirty minutes and provides a detailed statutory and regulatory background on clinical trial listing requirements, required forms that should be used, which studies require listing on Clinicaltrials.gov, who is responsible for the posting, what information is required in the posting including a statement of compliance, completed Form FDA 3674, which will satisfy the statement of compliance, information regarding the study including eligibility for inclusion in the study, and, ultimately, the results, all of which must be posted under the regulations at 42 CFR Part 11.
The training session can be found here. As noted, the training targets clinical investigators but also provides a good background to assist sponsors in navigating the clinical trial listing requirements so they do not run afoul of the requirements and end up entangled in the FDA’s part of the process, which involves enforcement for failure to comply.
