Risks should be considered across which areas in clinical trials?

• A. Processes and systems used in the trial, including trial design, participant selection, informed consent, randomisation, blinding, product administration, data handling, and service provider activities
• B. Only the informed consent process
• C. Only data handling and statistical analysis
• D. Only site monitoring activities

Answer: (A)

Risk assessment in clinical trials should consider every aspect that could affect participant safety or data integrity. A risk-based approach looks across how the trial is designed and conducted, including how participants are selected, how consent is obtained, how randomization and blinding are implemented, how the investigational product is administered, how data are collected and handled, and how any service providers are involved. Focusing on just one area—such as informed consent, data handling, site monitoring, or any single component—can miss other meaningful risks that could impact rights and welfare or the reliability of trial results. For example, issues in randomization can introduce bias, problems in data handling can compromise data integrity, and deficiencies in consent processes can affect participant rights and understanding. Because risks span these multiple domains, the comprehensive option is the best answer.