Publisher's Synopsis
The book is a result of 12+ years of author's experience in 100+ clinical trials to provide a focused insight of monitoring activities in more efficient and GCP compliant fashion. The book covers all the essential activities and their applications which includes Investigatory Site Selection and Assessment, Development of Monitoring Plan, Site Initiation, Review of Essential Clinical Trial Documents, Delegation of Duties and Responsibilities at Individual Trial Site, Inventory Planning, CRF Review and Collection, Coordination for Data Management, SAE Review, Regulatory Compliance, Investigational Product Management, Escalation and Management of Violations, Enrollments Tracking, Payment, Correspondence, Site Closure etc.
