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Natasha Martien - The sourcebook for clinical research : a practical guide for study conduct

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The sourcebook for clinical research : a practical guide for study conduct: summary, description and annotation

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A single trial is complex, with numerous regulations, administrative processes, medical procedures, deadlines and specific protocol instructions to follow. And yet, there has existed no single-volume, comprehensive clinical research reference manual for investigators, medical institutions, and national and international research personnel to keep on the shelf as a ready reference to navigate through trial complexities and ensure compliance with U.S. Federal Regulations and ICH GCP until The Sourcebook for Clinical Research. An actionable, step-by-step guide through beginning to advanced topics in clinical research with forms, templates and checklists to download from a companion website, so that study teams will be compliant and will find all the necessary tools within this book. Additionally, the authors developed Display Posters for Adverse Events Plus Reporting and Medicare Coverage Analysis that can be purchased separately here: https://www.elsevier.com/books-and-journals/book-companion/9780128162422/order-display-posters. Moreover, The Sourcebook for Clinical Research contains clear information and guidance on the newest changes in the industry to keep seasoned investigators and staff current and compliant, in addition to providing detailed information regarding the most complex topics. This book serves as a quick, actionable, off-the-shelf resource to keep by your side at the medical clinic. Read more...
Abstract: A single trial is complex, with numerous regulations, administrative processes, medical procedures, deadlines and specific protocol instructions to follow. And yet, there has existed no single-volume, comprehensive clinical research reference manual for investigators, medical institutions, and national and international research personnel to keep on the shelf as a ready reference to navigate through trial complexities and ensure compliance with U.S. Federal Regulations and ICH GCP until The Sourcebook for Clinical Research. An actionable, step-by-step guide through beginning to advanced topics in clinical research with forms, templates and checklists to download from a companion website, so that study teams will be compliant and will find all the necessary tools within this book. Additionally, the authors developed Display Posters for Adverse Events Plus Reporting and Medicare Coverage Analysis that can be purchased separately here: https://www.elsevier.com/books-and-journals/book-companion/9780128162422/order-display-posters. Moreover, The Sourcebook for Clinical Research contains clear information and guidance on the newest changes in the industry to keep seasoned investigators and staff current and compliant, in addition to providing detailed information regarding the most complex topics. This book serves as a quick, actionable, off-the-shelf resource to keep by your side at the medical clinic

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The Sourcebook for Clinical Research A Practical Guide for Study Conduct First - photo 1
The Sourcebook for Clinical Research
A Practical Guide for Study Conduct

First Edition

Natasha Martien

Jeff Nelligan

Copyright Academic Press is an imprint of Elsevier 125 London Wall London - photo 2

Copyright

Academic Press is an imprint of Elsevier

125 London Wall, London EC2Y 5AS, United Kingdom

525 B Street, Suite 1650, San Diego, CA 92101, United States

50 Hampshire Street, 5th Floor, Cambridge, MA 02139, United States

The Boulevard, Langford Lane, Kidlington, Oxford OX5 1GB, United Kingdom

2018 Natasha Martien and Jeff Nelligan. Published by Elsevier Inc. All Rights Reserved.

No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, or any information storage and retrieval system, without permission in writing from the publisher. Details on how to seek permission, further information about the Publishers permissions policies and our arrangements with organizations such as the Copyright Clearance Center and the Copyright Licensing Agency, can be found at our website: www.elsevier.com/permissions.

This book and the individual contributions contained in it are protected under copyright by the Publisher (other than as may be noted herein).

Notices

Knowledge and best practice in this field are constantly changing. As new research and experience broaden our understanding, changes in research methods, professional practices, or medical treatment may become necessary.

Practitioners and researchers must always rely on their own experience and knowledge in evaluating and using any information, methods, compounds, or experiments described herein. In using such information or methods they should be mindful of their own safety and the safety of others, including parties for whom they have a professional responsibility.

To the fullest extent of the law, neither the Publisher nor the authors, contributors, or editors, assume any liability for any injury and/or damage to persons or property as a matter of products liability, negligence or otherwise, or from any use or operation of any methods, products, instructions, or ideas contained in the material herein.

Library of Congress Cataloging-in-Publication Data

A catalog record for this book is available from the Library of Congress

British Library Cataloguing-in-Publication Data

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

ISBN: 978-0-12-816242-2

For information on all Academic Press publications visit our website at https://www.elsevier.com/books-and-journals

Publisher Andre G Wolff Acquisition Editor Erin Hill-Parks Editorial - photo 3

Publisher: Andre G. Wolff

Acquisition Editor: Erin Hill-Parks

Editorial Project Manager: Samuel Young

Production Project Manager: Punithavathy Govindaradjane

Cover Designer: Mark Rogers

Typeset by SPi Global, India

Dedication

This book is dedicated to my two beloved children, Dillon and Alexis, and to all of my wonderful friends in Annapolis who bring so much happiness into my life.

Natasha Martien

About the Authors

Natasha Martien , MBA, CCRP, SSBBP, CRCP, is a Human Subjects Research regulatory expert with 25 years of clinical research and healthcare management experience at institutes including Johns Hopkins Hospital, The Center for Cardiac and Vascular Research, and Scripps Clinic and Research Foundation. Martien has performed every operational role in clinical research at sites, including: training IRB members, Investigators, and Research Coordinators; regulatory management; working for an Office of Human Research Protections supporting an IRB; Research Coordination; writing and negotiating clinical trial agreements and budgets; financial management and billing; Coverage Analysis; CTMS acquisition; data analysis; credentialing; Quality Assurance; writing consent forms and study materials; compliance; advertising and recruiting; and the creation of a Clinical Trials Office. Martien has conducted and managed Investigator-Initiated, Industry- and Grant-funded studies in 24 medical disciplines and for a wide variety of study types, such as INDs, IDEs, biologics, stem cells, behavioral, pilot, observational, chart reviews, and clinical trial Phases IIV.

Jeff Nelligan , J.D., is a Washington, D.C.-based executive with extensive healthcare oversight, regulatory, and finance experience in three Federal Cabinet agencies and in the Legislative branch, including: as a Director at the Centers for Medicare and Medicaid Services (CMS) within the U.S. Department of Health and Human Services; as a Managing Director at the U.S. Government Accountability Office (GAO); and as a senior staffer for three Members of Congress in the U.S. Senate and the U.S. House of Representatives. He is a graduate of Williams College and Georgetown University Law Center.

Preface

Natasha Martien ; Jeff Nelligan

Why This Book?

Despite more than $40 billion in annual funding for clinical trials worldwide, there is no comprehensive book for investigators, institutions, and research organizations which covers beginning, intermediate, and advanced topics in clinical research. And yet, a single study is invariably complex, with numerous federal regulations, administrative processes, medical procedures, time windows, and specific protocol instructions to follow.

This book provides a succinct, useful, and up-to-date roadmap to guide research professionals step-by-step through the clinical trial and clinical research labyrinth. Moreover, The Sourcebook is written in such a way as to be understood by a Ph.D., an M.D., nurse, research coordinator, pharmacist, institutional administrator, IRB members, data analysts, and back-office research support personnel.

The Sourcebook for Clinical Research: A Practical Guide for Study Conduct has the largest clinical research glossary of any website available today, and has more than 30 Appendix items, including templates, forms, checklists, and diagrams that the reader can customize and download for immediate use. Website can be found at https://www.elsevier.com/books-and-journals/book-companion/ 9780128162422. Please note that the URL may change over time. For any updates, please see the books main webpage at the online Elsevier Store. In addition, this book provides knowledge and instruction on how to meet the demands of federal regulations in an urgent clinical situation.

Who IS This Book For?
  • - Every member of an Investigative Team
  • - Practitioners who desire to start working in research and have added a clinical trial to their practice but perhaps are not versed in the complexity of clinical trial regulations and project management;
  • - Research professionals who want to have one source they can use in order to stay in compliance with clinical research conduct;
  • - The seasoned Principal Investigator who occasionally needs answers to questions or/and needs guidance in advanced/complex topics;
  • - Data Entry Specialists who need to understand the full scope of trials to better understand the context and importance of their data input;
  • - Pharmacists who need understanding of research protocols and IND regulations;
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