Abstract
BACKGROUND: On-site monitoring by the institutional ethics committee (IEC) is one of the most effective ways to ensure compliance during research conduct. OBJECTIVES: The objectives of this study were to analyze the reports of clinical trial (CT) site monitoring conducted by IEC from January 2021 to March 2024 and to assess the impact of the monitoring by analyzing compliance reports submitted by the trial site team. METHODOLOGY: A retrospective analysis of site monitoring and compliance reports was conducted after obtaining necessary approvals from IEC. RESULTS: The present study analyzed 22 reports of site monitoring conducted from 2021 to 2024. A total of 56 deviations were observed during monitoring. The most common deviations observed were related to documentation and record-keeping (31/56). In many cases, logs were incomplete (10/56). Traveling allowance (TA) was given but receipt was not maintained (4/56). Major observed were deducting expenses of consumables from TA, not giving TA and ICF was not signed and dated by patient/LAR. Based on monitoring report, query letters were sent to respective PIs with instructions to submit explanations and compliance reports. The PIs submitted compliance report mentioning CAPA in response to deviations pointed out by ethics committee monitoring team and submitted their reports to the IEC. The percentage improvement in ethical conduct of trials was 96.42%. CONCLUSION: In the present study, active trial site monitoring helped the IEC to identify deviations that were impossible to identify by passive monitoring. Majority of deviations were resolved after being pointed out by IEC highlighting the importance of active monitoring. Thus, on-site CT monitoring is a critical aspect of ethical oversight, ensuring participant safety, maintaining data integrity and credibility, detecting compliance issues, and enhancing trust and transparency.