CITI: Monitoring of Clinical Trials by Industry Sponsors Questions and Answers | Latest Version | 2025/2026 | Correct & Verified

CITI: Monitoring of Clinical Trials by Industry Sponsors Questions and Answers | Latest Version | 2025/2026 | Correct & Verified What is the primary purpose of monitoring clinical trials by industry sponsors? To ensure participant safety, data integrity, and regulatory compliance throughout the trial. Who is typically responsible for conducting sponsor monitoring visits? A qualified clinical monitor or clinical research associate (CRA). What are the main components of a monitoring plan? Frequency of visits, responsibilities, data verification procedures, and corrective action processes. Why is source data verification important during monitoring? To confirm that study data recorded in case report forms accurately reflect participant records. 2 What is the purpose of an on-site monitoring visit? To review study conduct, verify compliance, and ensure proper documentation. Why must sponsors monitor informed consent documentation? To ensure participants provided voluntary and documented consent before enrollment. What is a remote monitoring visit? A monitoring activity conducted off-site using electronic data review and communication with the study site. Why is monitoring critical in multicenter trials? To ensure consistency, protocol adherence, and data quality across all sites. What should a monitor check regarding investigational product storage? That the product is stored according to protocol and regulatory requirements. How does monitoring help detect protocol deviations? By reviewing source data and study documentation for compliance issues. 3 Why is it important for sponsors to monitor adverse event reporting? To ensure timely, accurate reporting of safety information to regulatory authorities. What is the difference between verification of critical data and non-critical data? Critical data affect participant safety and primary study endpoints, while non-critical data have less impact. Why must monitors review regulatory binders at study sites? To confirm all required documents, approvals, and communications are complete and up to date. What is the significance of monitoring enrollment and eligibility? To ensure that only participants meeting inclusion/exclusion criteria are enrolled. How can monitoring prevent data inconsistencies? By regularly reviewing case report forms against source documents and resolving discrepancies.