A site is starting up a Phase III trial.

Before a clinical trial site can begin enrolling participants, there must be a signed clinical trial agreement (CTA) between the site and the sponsor. This agreement outlines the responsibilities, financial arrangements, and expectations between both parties, ensuring that the trial is conducted in compliance with regulatory and ethical standards.

GCP guidelines require that a formal agreement be in place before trial initiation to protect the rights and obligations of both the sponsor and the site.

"Before subject enrollment can commence, the sponsor and site must finalize a clinical trial agreement, establishing legal and ethical commitments."

Objectives:

Ensure proper contractual arrangements before trial initiation.

Protect legal rights and obligations of involved parties.