Tag: sponsor oversight IRB compliance

IRB Oversight Failures in Multicenter Clinical Trials

September 4, 2025

IRB Oversight Failures in Multicenter Clinical Trials Why IRB Oversight Failures Are Common in Multicenter Clinical Trials Introduction: The Challenges of Multicenter IRB Oversight Multicenter clinical trials involve multiple investigator sites across regions or countries, increasing complexity in regulatory oversight and ethical review. Institutional Review Boards (IRBs) or Ethics Committees (ECs) are responsible for ensuring…

Ethics Committee / IRB Audit Findings, Regulatory Audit Findings

Delayed Protocol Amendment Approvals Reported as Audit Findings

September 3, 2025

digi

Delayed Protocol Amendment Approvals Reported as Audit Findings Why Delayed Protocol Amendment Approvals Are Recurring IRB Audit Findings Introduction: The Importance of Timely Protocol Amendment Approvals Protocol amendments are a routine part of clinical trial conduct, addressing safety issues, operational adjustments, or regulatory feedback. However, these amendments must be reviewed and approved by Institutional Review…

Ethics Committee / IRB Audit Findings, Regulatory Audit Findings