Good Clinical Practice and Site Start-Up

Approval is the beginning, not the end. This level covers the Good Clinical Practice principles that apply even to observational work, a proportionate GCP-lite approach for low-resource settings, and the practical steps of activating a site and organising a competent team.

Who this level is for

PIs, study coordinators and project managers responsible for starting and running a site. Recommended after Levels 1-2.

What you'll learn

• The essential GCP principles: participant protection, data integrity and documentation ("if it isn't documented, it didn't happen")
• A GCP-lite, risk-proportionate approach that fits small projects in low-resource settings
• The site start-up checklist: approvals, contracts, supplies, data systems and the initiation visit
• Roles and responsibilities, and how a delegation log records who may do what
• How to train the study team, check competency, and refresh training when the protocol changes

You finish with: A site start-up checklist, a delegation log and a training plan.