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

By Edyta Niebrzegowska

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. 
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.  
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. 
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. 
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. 
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.

• Language: English
• Publisher: Troubador Publishing Ltd
• Release date: Feb 28, 2019
• ISBN: 9781789019926

Book preview

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Copyright © 2019 Edyta Niebrzegowska

The moral right of the author has been asserted.

Apart from any fair dealing for the purposes of research or private study, or criticism or review, as permitted under the Copyright, Designs and Patents Act 1988, this publication may only be reproduced, stored or transmitted, in any form or by any means, with the prior permission in writing of the publishers, or in the case of reprographic reproduction in accordance with the terms of licences issued by the Copyright Licensing Agency. Enquiries concerning reproduction outside those terms should be sent to the publishers.

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ISBN 978 1789019 926

British Library Cataloguing in Publication Data.

A catalogue record for this book is available from the British Library.

Matador is an imprint of Troubador Publishing Ltd

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

Reviews for Documentation of Clinical Trial Monitoring

[Stasia · Rating: 5 out of 5 stars]

Transparent and easy to understand, yet well referenced with legislative acts from FDA, ICH GCP, and EU Directives. Great example documents. It can be a useful learning tool for all of those planning to start their career in the clinical trials field.