Who is responsible for defining, establishing, and allocating all trial-related duties and functions prior to...

The sponsor is responsible for defining, establishing, and allocating all trial-related duties and functions before the trial begins. This includes outlining roles and responsibilities in collaboration with investigators, CROs, and other stakeholders. Proper delegation ensures the trial is conducted according to protocol and regulatory requirements.

This answer is verified based on GCP guidelines, which clearly state that sponsors are responsible for the organization and management of trial-related tasks.

"The sponsor is responsible for allocating duties and functions related to the conduct of the trial, ensuring compliance with regulatory and ethical standards."

Objectives:

Clarify the sponsor's role in clinical trial management

Define responsibilities in trial planning