Overview

This concise e-book provides clinicians as well as administrative personnel involved in clinical research with an understanding of documentation related to clinical trial monitoring activities at each stage of the study from planning and set up, through conduct and close-out.

Author and Standards

It has been written by an experienced clinical research associate in accordance with ICH GCP (both E6 R1 and its updated E6 R2 version) as well as modern monitoring practices.

Contents and Templates

It includes complete templates of clinical trial monitoring plan, site initiation visit report, monitoring visit during trial conduct report as well as trial close-out visit report. Each comes with detailed description and instructions as well as rich examples based on a fictional clinical trial scenario to give the readers best understanding of different aspects of clinical trial monitoring.

Guide and Reference

This easy-to-use guide helps to learn how to write monitoring plans and reports from scratch as well as is a handy reference for experienced trial administrators.

Monitoring Requirements and Documentation

It introduces the readers to clinical trial monitoring requirements as well as lists and conveniently summarises all types of clinical research monitoring documentation which can be found in Investigator and Trial Master File.

Format and Audience

Created in a convenient electronic format, this book is an important resource for research and administrative staff including CRAs and trial managers as well as doctors, research nurses and other healthcare personnel.