Final answer:
The statement is true; sites are required to comply with requests from authorities like monitors, auditors, the IRB/IEC, and the FDA to provide access to trial-related records to ensure compliance and participant safety in clinical trials.
Step-by-step explanation:
The statement is true; the site is required to allow monitors, auditors, the Institutional Review Board (IRB)/Independent Ethics Committee (IEC), the Food and Drug Administration (FDA), and other regulatory authorities to access trial-related records upon request. This access is necessary for the oversight of clinical trials to ensure the protection of human subjects, integrity of the data, and compliance with regulatory requirements. Researchers have an obligation to protect the privacy of research participants, but regulatory authorities have the right to review trial data and records to verify compliance. The FDA has the power to require postmarketing risk management plans and surveillance for certain drugs, which can include Phase IV trials or other restrictions, and can issue a clinical hold during clinical trials if significant problems are identified.