Investigator Initiated Trials (IITs) Simplified

This book is designed to serve as a guide for the clinical trial investigator who is willing to initiate clinical study from their own. The chapters include Basics of IITs, IIT and Regulation, IIT and Association with Industry, Protocol Designing, Budget Preparation, Case Report Form, Informed Consent, Reporting, Clinical Trial Registration, EC Submission, Conduct and Monitoring, Data Management, CSR Preparation etc. Each chapter is thoughtfully developed to simplify the job of a clinical trial investigator.