What entity is responsible for deciding whether a reaction in a trial using an active comparator or placebo should be reported to the manufacturer or to regulatory agencies?

What entity is responsible for deciding whether a reaction in a trial using an active comparator or placebo should be reported to the manufacturer or to regulatory agencies?

• A. Sponsor
• B. Investigator
• C. Ethics Committee
• D. Regulatory Authority

Answer: (A)

In safety reporting, the sponsor is the one who decides what information needs to be reported to regulators or to the sponsor’s own company that manufactures the product. The investigator alerts the sponsor to adverse events, and the sponsor reviews each event for seriousness, causality, and expectedness. If an event meets reporting requirements (for example, a SUSAR—serious, unexpected, and related), the sponsor is responsible for submitting the report to regulatory authorities and, as required, to ethics committees. This responsibility exists regardless of whether an active comparator or placebo is used. The ethics committee and regulatory authorities receive reports, but they do not decide what must be reported; the sponsor handles that decision and the regulatory submissions.

In safety reporting, the sponsor is the one who decides what information needs to be reported to regulators or to the sponsor’s own company that manufactures the product. The investigator alerts the sponsor to adverse events, and the sponsor reviews each event for seriousness, causality, and expectedness. If an event meets reporting requirements (for example, a SUSAR—serious, unexpected, and related), the sponsor is responsible for submitting the report to regulatory authorities and, as required, to ethics committees. This responsibility exists regardless of whether an active comparator or placebo is used. The ethics committee and regulatory authorities receive reports, but they do not decide what must be reported; the sponsor handles that decision and the regulatory submissions.