Self-Reporting in Clinical Trials

In this video, Edye Edens and Darshan Kulkarni discuss whether sponsors, sites, CROs, or IRBs should self-report compliance issues. Edye, who focuses on sites, explains that whether or not to self-report is highly situation-dependent. Some situations legally require reporting, while in others, organizations might have room to implement corrective actions without immediate reporting—but they must carefully understand applicable regulations and enforcement trends.

Darshan highlights the distinction between “should you report” and “is it reportable.” Not everything unethical is legally reportable, but stakeholders must assess the risks of not reporting, including potential regulatory, investor, or reputational fallout. He also warns that just because an SOP says “do not report,” that might not align with current regulations or enforcement priorities—and could even expose the organization to greater liability.

The conversation also touches on recent Trump administration statements that encourage self-reporting by offering some protection from prosecution—though Edye cautions that administrations often shift their enforcement priorities, so organizations should not rely solely on these statements as a shield. Both agree that any self-reporting should be accompanied by a robust corrective action plan already underway to show good faith. Otherwise, agencies could still decide to prosecute, especially in egregious cases.

Bottom line:
 Self-reporting can build trust and potentially reduce penalties, but only if handled thoughtfully. Assess the legal requirements, business risks, and your agency’s enforcement climate before deciding to disclose.