The sponsor is responsible for initiating a clinical trial. This involves developing the protocol, securing funding, selecting study sites, and obtaining regulatory approvals. The sponsor also oversees the conduct of the trial to ensure compliance with GCP and regulatory requirements.

According to GCP guidelines, the sponsor is the entity that initiates, manages, and finances the clinical investigation.

"The sponsor is responsible for initiating, managing, and financing the clinical trial, including protocol development and site selection."

Objectives:

Understand the sponsor’s role in trial initiation.

Ensure compliance from the outset of the study.