SOCRA CCRP Practice Exam

What additional documents must be kept by the sponsor only during a trial?

1. Audit certificate, Final close-out monitoring report, Treatment allocation and decoding documents

2. Investigator brochure, Protocol deviations, Signed consent forms

3. Regulatory submission documents, Financial contracts, Insurance documentation

4. Safety reports, Annual reports, Publication policies

The correct answer is: Audit certificate, Final close-out monitoring report, Treatment allocation and decoding documents

Sponsor for a clinical trial is often responsible for keeping track and maintaining an audit certificate, final close-out monitoring report, and treatment allocation and decoding documents. These documents are specifically important because they ensure that the data collected during the trial is accurate and can be verified by an external party. The other options are incorrect because they are either the responsibility of the investigator or do not directly pertain to record-keeping during the trial. The sponsor is also responsible for financial and regulatory submissions but these are not specific to record-keeping during the trial. Similarly, safety reports, annual reports, and publication policies are the responsibility of the entire trial team and not just the sponsor.