The sponsor should submit to regulatory authorities all safety updates and periodic reports as required by which of the following?

• A. All safety updates
• B. The sponsor's annual internal policy
• C. Interim safety communications only
• D. Applicable regulatory requirement(s)

Answer: (D)

Reporting safety information to regulators is governed by external rules, not internal policies. The sponsor must submit all safety updates and periodic reports as required by applicable regulatory requirement(s). These requirements specify what to report, how to report it, and when (for example, expedited SUSAR reporting, annual/periodic safety update reports, and other safety communications). Internal policies or interim communications alone do not satisfy regulatory obligations. So, the obligation comes from the regulatory framework in the jurisdictions where the trial is conducted, and the sponsor must follow those specific requirements.