Who is responsible for the accuracy of the clinical database summary?

• A. Investigators are solely responsible for accuracy
• B. Sponsors and investigators share responsibility and must ensure data are accurate and complete
• C. Regulatory authorities ensure accuracy
• D. Patients verify the data

Answer: (B)

In clinical trials, data integrity is a shared responsibility. The clinical database summary reflects all trial data and must be accurate and complete to support valid conclusions. The sponsor has overall responsibility for data management, including designing the data collection, validating entries, resolving data queries, and ensuring the database accurately represents the source documents. The investigator is responsible at the site for the accuracy of the data at the source, ensuring that the case report forms reflect the true information from source documents, and promptly addressing any discrepancies through corrections or clarifications. Regulatory authorities oversee compliance but do not themselves guarantee data accuracy, and patients do not verify the data. Therefore, both sponsors and investigators must work together to ensure data are accurate and complete.