16  Site Start-Up & Activation

16.1 Purpose

This module defines the CRA’s role in site feasibility, initiation, and activation to ensure sites are prepared to conduct the trial in compliance with protocol and regulatory requirements. As shown in the Trial Lifecycle Map, Start-Up represents the transition from site identification to activation and enrollment.

16.2 CRA Accountability (Practical)

• Assess site suitability and readiness
• Support Site Initiation Visit (SIV) execution
• Verify training, documentation, and system access
• Confirm activation criteria are met before enrollment

16.3 Scope

Applies to all interventional clinical trials. Therapeutic-area considerations (oncology, infectious disease) are highlighted where relevant.