Who must have access to trial-related records upon request?

Access to trial-related records is essential for ensuring the integrity, quality, and compliance of clinical trials. The correct option specifies that monitors, auditors, Institutional Review Boards (IRBs) or Independent Ethics Committees (IECs), the Food and Drug Administration (FDA), and other regulatory authorities must have access to these records upon request. This access is crucial for several reasons:

1. Compliance and Oversight: Regulators and oversight bodies like the FDA have a mandate to ensure that clinical trials are conducted in accordance with both ethical standards and regulatory requirements. This includes verifying that investigators adhere to good clinical practices (GCP) and that participants' rights and welfare are protected.

2. Quality Assurance: Monitors and auditors are responsible for verifying that the data collected during the trial is accurate and that the trial is being conducted as per the study protocol. They check records for consistency and compliance, which is vital for the credibility of the study results.

3. Ethical Considerations: IRBs/IECs review the trial protocols to ensure that the studies' ethical aspects are sound before they are approved to begin. Having access to trial-related records allows them to oversee the ongoing compliance with their initial reviews.

This multifaceted need for access