Documentation of Clinical Trial Monitoring: A practical guide compliant with Good Clinical Practice

Copyright © 2019 Edyta Niebrzegowska

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ISBN 978 1789019 926

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I sincerely thank my colleagues Marta Gielniewska, Mari-liis Pakats, Dr Barbara Marciniak, Tim Martin and Dr Julia Sloane-Murphy for their kind advice and valuable suggestions which supported me in creation of this e-book.

The information contained in this publication is believed to be correct at the time of manufacture. Whilst care has been taken to ensure that the information is accurate, the author can accept no responsibility for any errors or omissions or changes to the details given.

All examples presented in this book are fictional and should not be followed as medical, clinical, or scientific advice. Names, characters, businesses, places, events and incidents used in examples are either the products of the author’s imagination or used in a fictional manner. Any resemblance to actual persons, living or dead, or actual events is purely coincidental.

Contents

Abbreviations

Part 1

AN INTRODUCTION TO CLINICAL TRIAL MONITORING

Introduction

Clinical trial monitoring activities

Documentation of clinical trial monitoring

Part 2

MONITORING DOCUMENTATION TEMPLATES

Clinical trial scenario

Trial monitoring plan description

Trial monitoring plan template with examples

Pre-trial and trial initiation monitoring visit report description

Site initiation visit (SIV) report template with examples

Trial monitoring visit (during trial conduct) report description

Trial site monitoring visit (during trial conduct) report template, with examples

Trial close-out monitoring visit (after trial conduct) report description

Trial site monitoring visit for trial close-out report template with examples

Site monitoring visit log description

Site monitoring visit log template with examples

References

Abbreviations

Part 1

AN INTRODUCTION TO CLINICAL TRIAL MONITORING

Introduction

Clinical research involving human