Which topic addresses the integrity of data and the validity of computer software used in data handling?

• A. Evaluation of Safety and Tolerability
• B. Integrity of Data and Computer Software Validity
• C. Integrated Summary
• D. Set of Subjects to be Evaluated and Presentation of Data

Answer: (B)

The main idea here is about ensuring data are trustworthy and handled correctly, which means two things: keeping data accurate and complete throughout their lifecycle, and making sure the software used to collect, manage, and analyze that data is properly validated and functioning as intended. Data integrity means data are recorded, stored, transferred, and retrieved without unauthorized changes, with appropriate controls, audits, and traceability. Computer software validity (validation) ensures that the systems used for data capture and processing have been tested and documented to perform their intended functions correctly, with proper versioning, change control, access restrictions, and backup/recovery plans. Together, these aspects protect the reliability of trial results and align with regulatory expectations for electronic records and data handling.

The other options focus on different areas—safety outcomes, how data are combined and summarized, or what subjects and data will be evaluated and presented—rather than on safeguarding data integrity and validating the software used to manage that data.