Ace the ACRP Clinical Research Pro Exam 2026 – Dash into Data with Confidence!

Question: 1 / 400

What is required before a site can begin enrolling subjects in a phase 3 trial after receiving IRB approval?

Site readiness assessment must be completed

A signed clinical trial agreement between the site and sponsor is in place

Before a site can begin enrolling subjects in a phase 3 trial after receiving IRB approval, it is essential to have a signed clinical trial agreement in place between the site and the sponsor. This agreement outlines the responsibilities of both parties, the terms of the study, funding mechanisms, and other legalities. It ensures that both the site and the sponsor are in alignment regarding expectations, contractual obligations, and necessary resources for the trial.

Having this agreement finalized is crucial, as it formalizes the collaboration and provides a clear framework for conducting the research. Without it, there may be uncertainties regarding how the study will be supported, the management of any potential liabilities, and how data will be handled or shared. Thus, a signed clinical trial agreement is a fundamental requirement for moving forward with subject enrollment in the trial.

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Recruitment outreach must be initiated

Investigator must complete all training modules

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