- It will present best standards of practice and regulatory requirements for critical job functions of the Clinical Research Coordinator and methods for achieving these standards and requirements. The requirements of both programs are listed below.
- Basic Principles of Clinical Research and Methodology - SK Gupta 2. A Clinical Trials Manual From The Duke Clinical Research Institute - Kate. Free download from WHO site ( can Google ). There are a series of books created by CenterWatch for both the clinical research coordinator and the principal investigator.
- FOR GOOD CLINICAL RESEARCH PRACTICE (GCP). The handbook articulates the research processes and systems that need to be in place, and within these, the roles and responsibilities of various stakeholders (notably spon. HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE).
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Explore the Book. The handbook breaks down the role of a clinical research coordinator from start to finish and even provides templates and forms to help you on your career path. May 6, 2015 - Clinical Research Coordinator Handbook. You have full access to read online and download this title.
TRANSCRIPT
Practical Clinical Trials Series
Clinical Research Coordinator HandbookGCP Tools and TechniquesSecond Edition
Deborah Rosenbaum, CCRC, CCRA Michelle Dresser, RN, BSN
Interpharm /CRCBoca Raton London New York Washington, D.C.
2002 by CRC Press LLC
This material is presented as an interpretation of the clinical research process based on the expertise and experiences of the authors. therefore not all material will be relevant in every situation. Each situation must be assessed by the appropriate individual and appropriate actions chosen based on individual knowledge, and institutional and sponsor requirements. Every effort has been made to ensure that the contents of this book are factually correct, but the authors and the publisher do not accept liability for injury, damages, or losses arising from material published in this book.
Library of Congress Cataloging-in-Publication DataRosenbaum, Deborah. Clinical research coordinator handbook : GCP tools and techniques / Deborah Rosenbaum, Michelle Dresser2nd ed. p. cm.(Practical clinical trials series; v.2) Includes bibliographical references and index. ISBN 1-57491-123-6 (binder) 1. Clinical trialsManagementHandbooks, manuals, etc. I. Dresser, Michelle, 1960- . II. Title. III. Series. [DNLM: 1. Clinical Trialsmethods. 2. Clinical Trialsstandards. 3. Guideline Adherence. 4. Research Design. QV 771 R813c 2001] R853.C55 R67 2001 615.1901dc21 2001024953 CIP
Clinical Research Coordinator Handbook Free Download Programs
This book contains information obtained from authentic and highly regarded sources. Reprinted material is quoted with permission, and sources are indicated. A wide variety of references are listed. Reasonable efforts have been made to publish reliable data and information, but the authors and the publisher cannot assume responsibility for the validity of all materials or for the consequences of their use. Neither this book nor any part may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, microlming, and recording, or by any information storage or retrieval system, without prior permission in writing from the publisher. The consent of CRC Press LLC does not extend to copying for general distribution, for promotion, for creating new works, or for resale. Specic permission must be obtained in writing from CRC Press LLC for such copying. Direct all inquiries to CRC Press LLC, 2000 N.W. Corporate Blvd., Boca Raton, Florida 33431. Trademark Notice: Product or corporate names may be trademarks or registered trademarks, and are used only for identication and explanation, without intent to infringe.
Visit the CRC Press Web site at www.crcpress.com 2002 by CRC Press LLC Interpharm is an imprint of CRC Press LLC No claim to original U.S. Government works International Standard Book Number 1-57491-123-6 Library of Congress Card Number 2001024953 Printed in the United States of America 1 2 3 4 5 6 7 8 9 0 Printed on acid-free paper
2002 by CRC Press LLC
CONTENTS
Foreword Preface 1 Overview of Clinical ResearchWho Conducts Clinical Research The Drug Development Process Phases of Clinical Research Elements of Clinical Research in Clinical Research The Study Work Area Resources Bibliography 14 18 2 5
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Kung fu 1972 tv series download torrent. 2
The Role of the Clinical Research Coordinator
11 14
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FDA Regulations and Good Clinical Practice GuidelinesCode of Federal Regulations (CFR) ICH GCP Guideline 24 33 35 39 40 40 Responsibilities of Investigators Responsibilities of the Sponsor Electronic Signature (2 1 CFR 11) The Institutional Review Board Subject Informed Consent Regulatory References Contacts 56 57 Bibliography 55 50
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Financial Disclosure by Clinical Investigators
2002 by CRC Press LLC
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Clinical Research Coordinator Handbook
3.
Clinical Research Coordinator Handbook Free Download For Pc
The Study: Planning Stages and CommencementProtocol Development Study Commencement Study Termination Bibliography 82 78 61 62 70 74 The Planning Stages of a Study Keeping Up With the Study
Clinical Research Coordinator Handbook Pdf
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Interactions with the SponsorSite Monitoring Visits 84 84 85 Resolution of Problems Identified at Site Visits Grant-Sponsored Visits (Audits and Inspections) Telephone Monitoring Written Correspondence Investigator's Meetings Study Procedures Manual Bibliography 102 94 94 98 99
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Interactions Within the InstitutionThe Principal Investigator and Subinvestigators The Institutional Review Board Study Logistics Bibliography 105 105 107 Preparing Hospital Staff 103 103
6.
The Role of the Study SubjectThe Subject 109 Study Subject Recruiting 110 Obtaining Informed Consent 1 17 Assessing Subjects for Study Participation 120 122 Keeping the Subject on the Study/Facilitating Compliance Determining Noncompliance 126 Subjects Leaving the Study What Is an Evaluable Subject? Subject Compensation 128 129 127 128
Subjects and the Medical Team Relationship 2002 by CRC Press LLC
Contents
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Notes
133 133 137 137 138 139
Bibliography
7.
Data ManagementGeneral Issues in Developing Forms for Data Collection Assuring Data Are Collected Source Documents Analyzing the Data Reporting the Data Regulatory References Bibliography 146 140 144 144 145 Recording Data and Completing Case Report Forms
8.
Adverse EventsAdverse Events 147 Assessment of Adverse Events Recording Adverse Event Data Medical Management of Adverse Events 154 157 157 165 Unblinding the Study Because of an Adverse Event Serious Adverse Events: Expedited Reporting Handling a Subject Death in a Clinical Trial Regulatory References Bibliography 167 167
9.
Investigational Agent ManagementInvestigational Drug Agents in a Clinical Trial Code Breakers 17 1 17 1 172 174 Study Drug Labels 169 Brock script font free download.
Receiving and Storing the Investigational Agent Dispensing the Investigational Drug Agent Instructions to Study Subjects Study Drug Accountability Final Disposition Common Questions Regulatory References 2002 by CRC Press LLC
176 178
Destruction of the Investigational Drug Agent181 182 184
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Clinical Research Coordinator Handbook
Note
185 185
Bibliography
10.
Inspection of Clinical Research SitesWho, Why, and What TheDataAudit 196 196 197 187 192 Preparing for an Inspection At the End of the Inspection Regulatory References Bibliography 198
AppendicesA: FDA RegulationsIGCP Guidelines 201 21 CFR 50: Protection of Human Subjects 21 CFR 56: Institutional Review Boards2 1 CFR 3 12: Investigational New Drug Application
B: FDA Forms 277 157 1 : Investigational New Drug Application 1572: Statement of Investigator MEDWATCH Adverse Event Forms C: Protection of Human Subjects: Declaration of Helsinki D: Sample Schedule of Study Visits and Evaluations E: Algorithms 297 293 287
Surface Area HeightIWeight Conversions Military Time Temperature Conversion
Glossary of Terms 305 Abbreviations 329
2002 by CRC Press LLC
FOREWORD
The role of the Clinical Research Coordinator (CRC) is central to the successful conduct of a clinical trial. The CRC is involved in every important event in the trial. In fact, many of the investigator's responsibilities are primarily the CRC's operational responsibility, including screening patients to ensure rapid, accurate enrollment; managing patient scheduling and follow-up; informing subjects about the purpose and treatment plan of the study; preparing the site for implementation of the treatment plan; recording and verifying data in the Case Report Forms; keeping study files and records; ensuring study supplies are properly inventoried, stored, and reordered as necessary; correcting case report problems; and transmitting data to the sponsor/CRO. Investigators, site managers, Clinical Research Associates (CRAs), monitors, and project team leaders from the sponsor and Contract Research Organization (CRO) rely on the skills, knowledge, and abilities of a competent, trained, professional CRC. The role of the CRC has grown as the clinical research industry has expanded over the past fifteen years. Clinical Research and Development is a relatively young industry, and the role of the CRC is itself relatively new. Fifteen years ago some investigators were still managing their own Case Report Forms, a practice that is still surprisingly common in Europe and Japan. In the late 1980s, the Association of Clinical Research Professionals (ACRP), which today includes the largest CRC membership, was just organizing the CRC Education Committee and beginning to sponsor training programs for CRCs. In 1990, recognizing that the role of the CRC needed the status of a profession, CRCs in the ACRP began to outline a certification program for CRCs. The work vii 2002 by CRC Press LLC
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Clinical Research Coordinator Handbook
entailed in certification included important elements of a profession, including identification of job competencies that are important and unique to the professional engaged in the coordination of a clinical research study, development of a job description, and the development of professional standards. The CRC's evolving role was quickly supported by pharmaceutical companies and CROs, which, in their need for rapid enrollment and clean, quality data, saw the advantages of a professional dedicated to the conduct of the study. Through education and the site selection process, sponsors, CROs, and CRCs together have impressed upon investigators the importance of the skills and knowledge required of a CRC. Critical to the professionalization of the CRC is the institutionalization of their unique skills, knowledge, and abilities. Unlike most parts of nursing and health care, the CRC is governed not only by professional standards of the healthcare professional but also by a unique set of regulatory requirements, guidelines, and therapeutic area information sheets promulgated by the FDA and in some cases state regulatory agencies. These regulations, often known as the Good Clinical Practices (GCPs), place additional requirements on the CRC not required of other healthcare professionals. That there are, in addition, separate GCPs for the three therapeutic segments of drugs, biological compounds, and medical devices makes the job of the CRC all the more complicated. Add to that the fact that each sponsor and CRO has its own distinct set of Standard Operating Procedures (SOPS), Case Report Forms, and way of managing the study and the data, including various forms of remote data entry, the job of the CRC becomes quite complicated and challenging; it does indeed contain its own skill set; it is indeed a profession. In this book, Deborah Rosenbaum, who is both a Certified Clinical Research Coordinator (CCRC) and a Certified Clinical Research Associate (CCRA), and Michelle Dresser, who is a registered nurse with a BSN, have provided an eminently practical description of the responsibilities and functions of the CRC, prefaced by a comprehensive yet succinct guide through the GCP regulations and guidelines. Throughout they provide sample forms, checklists of duties and responsibilities, answers to common questions, and helpful hints, as well as bibliographies that extend the reader's knowledge base. This is a most helpful and practical guide for the CRC. Frederic Harwood, PhD Washington, D.C.
2002 by CRC Press LLC
Celestron digital microscope suite software download. PREFACE
Clinical research is a very exciting field-the
cutting edge of the future of the practice
of medicine. New drugs, new devices, new combinations of drugs, new methods of treatment, and new procedures are explored every day to shape the future of health care. The process of clinical research is also closely regulated by the U.S. Food and Drug Administration (FDA). As we were working together at Burroughs Wellcome Co. on human immunodeficiency virus (HIV) clinical trials and based on our own experiences as clinical research coordinators (CRCs), we realized a need for a practical reference tool for study coordinators and other research personnel on how to conduct clinical trials. One thing was obvious: most people doing clinical research (clinical research coordinators, investigators, and sometimes monitors) learned the job by on-the-job trial by fire. Although many references and articles about clinical research existed, most were theoretically based and failed to offer practical advice. There were few good references to actually help you GET THE JOB DONE. This completely revised edition of our original 1996 publication provides a logical, step-by-step guide to testing new drugs and treatment modalities in compliance with the latest FDA regulations. This is a handson tool for your operation with current forms, International Committee on Harmonisation good clinical practice (ICH GCP) information, FDA regulations, and other references. The first in a newly revised series aimed at clinical research professionals, this book is written as a reference for what occurs at the study site, in particular, a reference not only for the new study coordinator but also for experienced coordinators. We have provided a regulatory framework with helpful tips on how to accomplish the clinical research process at the site with the regulations in mind. We are sure we have not anticipated every circumstance, but we hope that this book will provide information to solve most problems.
2002 by CRC Press LLC
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Clinical Research Coordinator Handbook
We have also taken into consideration the content of the Association of Clinical Research Professionals (ACRP) CRC certification exam to determine that this book covers all significant parts of clinical research. Although the emphasis in the book might be marginally different from the emphasis of the exam, we feel we have provided information pertinent to the topics selected by the ACRP for the certification process. In addition, in training programs for CRCs, this book has been well received. Many participants found the book to be useful in their day-to-day activities of clinical trial management. The second book of this series is for the physician investigator, and the third is for the clinical research associate. Each of these books contains information pertinent to these three pivotal roles in the conduct of clinical research. Our goal is that eventually the process of clinical research, as approached by each of these disciplines, will be more consistent and done according to regulation. We would like to thank Pearl Rosenbaum, Fred Smith, and Susan Poe for their excellent review of the draft manuscript; Jonathon and Georgina Rosenbaum for the artwork in the book; and Laura Weygandt for her assistance with word processing. We'd like to thank our children, Brain Dresser and Sarah and Harrison Rosenbaum, for giving us those 'quiet-time' opportunities to write the book and for giving us true pleasure in our lives. Finally, we'd like to dedicate this book to our mothers, who have taught us so much about life. Deborah Rosenbaum Michelle Dresser August 2001
2002 by CRC Press LLC
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Clinical Research Coordinator Handbook
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