A Clinical Trials Manual From The Duke Clinical Research Institute Lessons from a Horse Named Jim

by Liu, Margaret; Davis, Kate

• ISBN13: 9781405195157
• ISBN10: 1405195150
• Edition: 2nd
• Format: Paperback
• Copyright: 2010-02-08
• Publisher: Wiley-Blackwell

Summary

"The publication of the second edition of this manual comes at an important juncture in the history of clinical research. As advances in information technology make it possible to link individuals and groups in diverse locations in jointly seeking the answers to pressing global health problems, it is critically important to remain vigilant about moral and ethical safeguards for every patient enrolled in a trial. Those who study this manual will be well aware of how to ensure patient safety along with fiscal responsibility, trial efficiency, and research integrity."-- Robert Harrington, Professor of Medicine, Director, Duke Clinical Research Institute, Durham, North Carolina, USAThe Duke Clinical Research Institute (DCRI) is one of the world's leading academic clinical research organizations; its mission is to develop and share knowledge that improves the care of patients around the world through innovative clinical research. This concise handbook provides a practical "nuts and bolts" approach to the process of conducting clinical trials, identifying methods and techniques that can be replicated at other institutions and medical practices.Designed for investigators, research coordinators, CRO personnel, students, and others who have a desire to learn about clinical trials, this manual begins with an overview of the historical framework of clinical research, and leads the reader through a discussion of safety concerns and resulting regulations. Topics include Good Clinical Practice, informed consent, management of subject safety and data, as well as monitoring and reporting adverse events.Updated to reflect recent regulatory and clinical developments, the manual reviews the conduct of clinical trials research in an increasingly global context. This new edition has been further expanded to include: In-depth information on conducting clinical trials of medical devices and biologics The role and responsibilities of Institutional Review Boards, and Recent developments regarding subject privacy concerns and regulations.Ethical documents such as the Belmont Report and the Declaration of Helsinki are reviewed in relation to all aspects of clinical research, with a discussion of how researchers should apply the principles outlined in these important documents. This graphically appealing and eminently readable manual also provides sample forms and worksheets to facilitate data management and regulatory record retention; these can be modified and adapted for use at investigative sites.

Author Biography

Margaret Liu is a clinical trials consultant based in Singapore and former manager of the Monitoring Group at the Duke Clinical Research Institute (DCRI).

Kate Davis is Business Development Specialist for DCRI Communications Group, Durham, NC, US.

Table of Contents

Foreword

Preface

List of Abbreviations

Lessons from a Horse Named Jim and Other Events in History Affecting the Regulation of Clinical Research

The Process: Developing New Drugs, Biologics, and Devices

The Drug Development Process

Developing New Devices

Postmarketing Surveillance of Drugs, Biologics, and Devices

Good Clinical Practice and the Regulations

Good Clinical Practice

Responsibilities in the Code of Federal Regulations

Where to Obtain Information and Guidance for the Regulations and GCP

Informed Consent and the Regulations

What Is Informed Consent?

Ethical Codes Regarding Informed Consent

Regulatory Requirements for Informed Consent

The Informed Consent Process

Institutional Review Boards

What is an Institutional Review Board?

IRB Activities

Types of IRB Review

Communication between IRBs and Investigators

Communication between IRBs and Study Sponsors

IRB Records and Reports

Accreditation of IRBs

Registration

Adverse Events and Unanticipated Problems Involving Risks to Subjects or Others

Why Collect Adverse Event Data?

Adverse Events

Unanticipated Problems Involving Risks to Subjects or Others

Investigator Responsibilities

IRB Responsibilities

Sponsor Responsibilities

Monitoring, Audits, and Inspections

Monitoring Plan

On-Site Monitoring

In-House Monitoring

Audits and Inspections

The Principal Investigator, the Clinical Research Coordinator, and the Study Site

The Principal Investigator

Staffing to Support Clinical Trials

Space and Resource Needs

The Local Institutional Review Board

The Protocol

Common Components of a Protocol

Background and Rationale

Study Organization

Objectives/Endpoints

Study Design

Study Population

Study Treatment Plan

Safety Assessment, Management, and Reporting

Replacement of Withdrawn, Dropped Out, and Lost to Follow-up Subjects

Statistical Aspects

Subject Data and Record Retention

Monitoring

Study Feasibility: Reviewing a Specific Protocol

Reviewing a Specific Protocol

Should We Do this Study at Our Site?

Study Activities

Study Start-up Phase

Study Maintenance Phase

Study Completion and Close-Out Phase

Study Documents/Essential Documents

Documents at Study Start-Up

Documents While the Study is in Progress

Documents at Study Close-out

Maintaining Your Site Study File

Management of Study Drugs, Biologics, and Devices

Study Drugs and Biologics

Study Devices

Managing Clinical Trial Data

HIPAA, the Privacy Rule, and Clinical Trial Data

Guidelines and Regulations Regarding Clinical Trial Data

Study Site Responsibilities Regarding Clinical Trial Data

Source Document Verification of Clinical Trial Data

Release of Protected Medical Information

Confidentiality of Clinical Trial Data

Endpoint Adjudication

Global Health and International Trials

International Clinical Trials

Ethnic and Racial Differences

Ethical Issues and Cultural Sensitivities

Why International Trials Are Important

International Regulations

Concerns

Future Efforts

Appendices

Epilogue

Glossary

Index

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