Standard Operating Procedure for Clinical Trial Sites
This course walks site staff through the essential Standard Operating Procedures (SOPs) that govern the conduct of clinical trials, from initial site set-up to study close-out. Structured across five modules, it covers the full lifecycle of a clinical trial site's responsibilities:
- Module 1 – Quality Management & Site Governance: Preparing SOPs, defining study team responsibilities, and ensuring proper training and handover practices.
- Module 2 – Study Start-up & Regulatory Management: Assessing protocol feasibility, executing clinical trial agreements, and coordinating with Institutional Ethics Committees.
- Module 3 – Clinical Trial Operations and Trial Management: Managing sponsor/CRO communication, site initiation through close-out, source documentation, investigational product, biological samples, and safety reporting.
- Module 4 – Participant Management: Obtaining informed consent, recruiting study subjects, and handling participant reimbursement.
- Module 5 – Study Close-out & Records Management: Archival of essential documents to ensure long-term regulatory compliance.
By the end of this course, you will have a clear, practical understanding of the SOPs required to run a compliant, well-governed clinical trial site — from first protocol review to final document archival.
Karkinos - LMS
