Site Start-up and Training

Site start-up and training are essential for establishing a strong foundation for clinical trials. Well-prepared investigational sites are more likely to conduct the trial effectively, maintain data integrity, and ensure patient safety while complying with regulatory standards and ethical principles. Overview of site start-up and training activities:

• Site feasibility assessment: evaluation of whether a site is capable of conducting the trial successfully.
• Regulatory submission: the site must obtain approvals from regulatory authorities
• Contract negotiation: negotiating agreements with site and vendors
• Site activation: officially initiating patient recruitment, data collection, and other trial-related activities
• Site training: site personnel is required to be trained on protocol, data collection procedures, and regulatory requirements