SOCRA CCRP Practice Exam

What essential document must be kept with a 3rd party before a trial?

1. IRB composition

2. CRFs

3. Master randomization list

4. Financial agreement

The correct answer is: Master randomization list

The essential document that must be kept with a 3rd party before a trial is the master randomization list, also known as the randomization code sheet. This document contains crucial information such as the treatment assignments and subject identification numbers, and is usually managed by a third party to ensure blinding and confidentiality. Option A, IRB composition, is incorrect because this is a document that outlines the makeup and responsibilities of the Institutional Review Board (IRB) that reviews and approves the trial protocol and procedures. This document is not kept with a third party, but rather is managed by the trial sponsor or investigator. Option B, CRFs (case report forms), is also incorrect because this is a standardized document used to collect and record data from the trial, and is not typically kept with a third party. Option D, financial agreement, is also incorrect because this is a document that