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TRANSCRIPT
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SECOND EDITION
HANDBOOK OF
SOPs FOR GOOD
CLINICAL PRACTICE
Celine M. Clive
Interpharm/CRC
Boca Raton London New York Washington, D.C.
© 2004 by CRC Press LLC
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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 author and thepublisher 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,
microÞlming, 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. Speci Þc
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 identiÞcation and explanation,
without intent to infringe.
Visit the CRC Press Web site at www.crcpress.com
© 2004 by CRC Press LLC
No claim to original U.S. Government works
International Standard Book Number 0-8493-2181-6
Library of Congress Card Number 2003064123
Printed in the United States of America 1 2 3 4 5 6 7 8 9 0
Printed on acid-free paper
Library of Congress Cataloging-in-Publication Data
Clive, Celine.
Handbook of SOPs for good clinical practice.—2nd ed. / Celine Clive.
p. ; cm.
Rev. ed. of: A handbook of SOPs for good clinical practice / Donald E. Maynard, B. Joyce
Baird. c1996.
Includes bibliographical references and index.
ISBN 0-8493-2181-6
1. Clinical trials—Standards—Handbooks, manuals, etc. 2. Clinical trials—Forms—
Handbooks, manuals etc.
[DNLM: 1. Research—standards—Handbooks. 2. Clinical Trials—standards—Handbooks. 3.
Human Experimentation—standards—Handbooks. 4. Legislation, Drug—Handbooks. W 49 C642h
2004] I. Title: Handbook of standard operating procedures for good clinical practice. II.
Maynard, Donald E. Handbook of SOPs for good clinical practice. III. Title.]
R853.C55C585 2004
610¢.72¢4—dc22 2003064123
© 2004 by CRC Press LLC
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Dedication
The author gratefully dedicates this book to Patrick and Josephine Meehan for their
continuous support and encouragement, and for providing an example to follow in life.
Celine M. Clive
© 2004 by CRC Press LLC
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© 2004 by CRC Press LLC
Introduction
This handbook is divided into three sections containing Standard Operating Procedures
(SOPs) applicable to the activities of the three major groups involved in the clinical
development process:
• The Sponsor/Contract Research Organization (CRO)
• The study site
• The Institutional Review Board (IRB)
A fourth section, called Forms, contains all of the attachments that are referred to in the
SOP sections. Some of the forms may apply to more than one group affected by the
SOPs. For example, the “Subject Information and Consent Form Checklist” may be used
by Study Coordinators, when they are developing the document, and IRB members, when
they are reviewing it.
The advantage of this handbook is that by using the material found on the CRC Web site:
www.crcpress.com/e_products/downloads/download.asp, each SOP and all of the forms
can be customized to the needs of the specific institution. To do this, the user should open
the document and make a global change replacing the word “Company” with the
company’s actual name. Be aware that the length of the company’s name may affect line
and page spacing and that some minor formatting may be needed after this global change
is implemented. If the institution’s logo is added to the header of the first page, the
formatting may also need to be checked. Finally, the effective date should be added to the
header of the second page. From there, it will automatically be captured on all subsequent
pages.
These templates should serve as a starting point for the development of SOPs. The user
should ensure that the specific processes at his/her institution are reflected in the final,
approved SOP.
The language in these SOPs may appear to be limited to drug development; however,
with a few alterations, they may be adapted to medical devices and biologics as well.
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About P PP P olaris olaris olaris olaris Clinical Research Consultants, Inc.
P olaris Clinical Research Consultants, Inc. is a training and auditing company specializing in
clinical research topics and processes. Our mission is to enhance the productivity andefficiency of clinical research teams by providing training, auditing, and Standard OperatingProcedure (SOP) development to our clients.
P olaris offers consulting services to pharmaceutical companies, Contract Research
Organizations (CRO), investigative sites, and Institutional Review Boards (IRBs). Thecompany offers several off-the-shelf training programs for Monitors, Investigators, Study
Coordinators, and IRB Members. Because we are interested in establishing collaborative
relationships with our clients, more often our training programs are customized to the specificneeds of our clients. We recognize the demand for experienced professionals exceeds the
supply and we believe that through training we can help bridge that gap.
Some of the advantages of using P olaris include:
• Active participation of the learners. P olaris ’ training programs are delivered through
exercises, case studies, role-playing, and worksheets. This active involvement by the
participant ensures that the lessons become more intrinsic and the learning becomes moreeffective.
• Experienced personnel. P olaris ’ training programs are developed and delivered by
experts in various areas of the pharmaceutical industry. This provides students with high
quality training that is realistic and practical.
• Program flexibility. P olaris ’ training is delivered so that the point-of-view and needs of
both the CRO and Sponsor company are discussed. Programs to investigative sites include
discussions on what site personnel are required to do by regulation and which tasks are
driven by Sponsor-specific requirements.
Celine M. Clive
Polaris Clinical Research Consultants, Inc.
130 Iowa Lane; Suite 103
Cary, NC 27511Telephone: 919-463-0003
Fax: 919-463-0004
E-mail: [email protected]
© 2004 by CRC Press LLC
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Programs Available through P olaris
• Overview of Drug Development
• Overview of Clinical Research
• History of the Regulations
• FDA Structure and Processes
• Regulations that Affect Clinical Research (FDA and ICH)
• The Responsibilities of Sponsors, Monitors, and Site Personnel
• The Responsibilities of Contract Research Organizations
• The Role of the Institutional Review Board
• Preparing Documents for Study Initiation
•
Selecting Investigators and Study Sites• Developing Protocols and Case Report Forms
• Conducting the Study Initiation Visit
• Developing and Obtaining Informed Consent
• Conducting the Interim Visit
• Adverse Experiences and Serious Adverse Experiences
• Editing Case Report Forms
• Interacting with the Study Coordinator
• Reviewing Regulatory Documents
• Case Report Form Tracking and Management
• Managing Clinical Trial Material/Drug Accountability
• Writing Trip Reports and Follow-Up Letters
• Role of Data Management in the Clinical Research Process
• Safety When Traveling
• Writing Protocols
• Designing Case Report Forms
• FDA Audits
• Detecting Fraud in Clinical Research
© 2004 by CRC Press LLC
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Table of Contents
Sponsor/Monitor/CRO SOPs
MON-001.0 Preparation, Issue, and Revision of Standard Operating
Procedures (SOPs)MON-002.0 Training Clinical Research Staff
MON-003.0 Selecting Investigators and Study Sites
MON-004.0 Developing Informed Consent Forms
MON-005.0 Conducting Site Evaluation Visits
MON-006.0 Conducting Study Initiation Visits
MON-007.0 Conducting Periodic Site Visits
MON-008.0 Reviewing Case Report Forms at the Study Site
MON-009.0 Reviewing Regulatory Documents
MON-010.0 Adverse Experiences (AEs), Serious Adverse Experiences
(SAEs), and IND Safety Reports
MON-011.0 Managing Study-Specific Clinical Supplies
MON-012.0 Conducting Study Termination Visits
MON-013.0 Telephone Contact Reports
Investigational Site SOPs
SITE-001.0 Preparation, Issue, and Revision of Standard OperatingProcedures (SOPs)
SITE-002.0 Training Study Site Clinical Research Staff
SITE-003.0 Assessing Protocol Feasibility
SITE-004.0 Investigator Agreements with Sponsors or Contract ResearchOrganizations
SITE-005.0 Organizational Chart for the Study Site
SITE-006.0 Interactions with the Institutional Review Board
SITE-007.0 Recruiting Study PatientsSITE-008.0 Study Initiation and Implementation
SITE-009.0 Reviewing and Obtaining Informed Consent
SITE-010.0 Adverse Experiences (AEs), Serious Adverse Experiences (SAEs)
and IND Safety Reports
SITE-011.0 Drug Storage and Accountability
© 2004 by CRC Press LLC
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SITE-012.0 Managing Biological Samples
SITE-013.0 Interactions with the Sponsor or Contract Research Organization
(CRO)
SITE-014.0 Study Files and Record Retention
Institutional Review Board SOPs
IRB-001.0 Institutional Review Board Responsibilities
IRB-002.0 IRB Membership and Training
IRB-003.0 Institutional Review Board Meetings
IRB-004.0 IRB Record Keeping
IRB-005.0 IRB Review of Research
IRB-006.0 IRB Review of Informed Consent
IRB-007.0 IRB Review of Advertisements
IRB-008.0 IRB Review of Unscheduled Mandatory Reports
IRB-009.0 Criteria for Exempt and Expedited Review
Forms – Alphabetical by File Name
File Name (.doc) Form Name
Ad Review Advertisement Review Checklist
Amendment Protocol Amendment Form
Bio Sample Biological Samples Inventory
CRF Review CRF Review Form
DCF Form Data Clarification Form
Dispense Drug Dispensing Log
Dispense by Pt Study Subject Investigational Product Dispensing Record
Drug Disposition Clinical Trial Materials Disposition Form
Drug Order Investigational Drug Shipping Order
Drug Receipt Investigational Product Receipt FormDrug Return Drug Return Form
Enrollment Screening and Enrollment Log
Expedited Expedited Review Form
ICF Review Subject Information and Consent Form Checklist
Init Doc Track Study Initiation Document Tracking Worksheet
© 2004 by CRC Press LLC
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Initial Sub Initial Submission Form
IRB Member IRB Membership Roster
Minutes Template IRB Meeting Minutes Template
Monitor Log Monitoring Log
Patient Master Master Subject Log
Phone Rpt Telephone Contact Report
Progress Rpt IRB Progress Report Form
Responsibilities Study Responsibilities Form
Review Cklist Reviewer’s Checklist
Review Results IRB Review Results Form
SAE Serious Adverse Experiences
Safety Rpt Safety Information Form
Sig Sheet Study Site Personnel Signature Sheet
St Term Ack IRB Study Termination Acknowledgement
St Term Notice IRB Notification of Study Termination Form
Training Plan Training Plan Form
Training Record Training Record Form
Training Request Staff Training Request Form
Training Verification Staff Training Verification Form
Trip Rpt Evaluation Site Evaluation Visit Trip Report
Trip Rpt Init Study Initiation Visit Trip Report
Trip Rpt Interim Periodic Site Visit Trip Report
Trip Rpt Termination Study Termination Visit Trip Report
© 2004 by CRC Press LLC