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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


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


http://www.crcpress.com/




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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


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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]


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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


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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


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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


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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
