What measures should be implemented to protect trial participants' personal information?

• A. None.
• B. Only the sponsor's internal policy.
• C. Public disclosure to improve transparency.
• D. Appropriate measures in accordance with applicable regulatory requirements on personal data protection.

Answer: (D)

Protecting trial participants' personal information means putting in place measures that meet the applicable regulatory requirements on data protection. This involves handling data in a way that minimizes what is collected, keeps it secure, and limits who can access it. Implement practical steps such as access controls, encryption, and de-identification or pseudonymization when possible; maintain clear data handling, retention, and destruction policies; ensure data sharing is governed by appropriate agreements and safeguards; and address cross-border transfers with the necessary protections. It also includes respecting participants’ rights to access, correct, or withdraw consent where applicable, training staff on privacy practices, and having incident response and auditing processes to detect and address breaches. Relying only on a sponsor’s internal policy or publicly disclosing information would not meet external legal and ethical obligations, and doing nothing would fail to protect confidentiality. Therefore, implementing measures in accordance with regulatory data protection requirements is essential.