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A Clinical Trials Manual From The Duke Clinical Research Institute: Lessons from a Horse Named Jim, 2nd Edition

ISBN: 978-1-4051-9515-7
424 pages
February 2010, Wiley-Blackwell
A Clinical Trials Manual From The Duke Clinical Research Institute: Lessons from a Horse Named Jim, 2nd Edition (1405195150) cover image
"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, USA

The 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.

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Foreword (Robert A. Harrington).


List of Abbreviations.

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

2 The Process: Developing New Drugs, Biologics, and Devices.

The Drug Development Process.

Developing New Devices.

Postmarketing Surveillance of Drugs, Biologics, and Devices.

3 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.

4 Informed Consent and the Regulations.

What Is Informed Consent?

Ethical Codes Regarding Informed Consent.

Regulatory Requirements for Informed Consent.

The Informed Consent Process.

5 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.


6 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.

7 Monitoring, Audits, and Inspections.

Monitoring Plan.

On-Site Monitoring.

In-House Monitoring.

Audits and Inspections.

8 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.

9 The Protocol.

Common Components of a Protocol.

Background and Rationale.

Study Organization.


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.


10 Study Feasibility: Reviewing a Specific Protocol.

Reviewing a Specific Protocol.

Should We Do this Study at Our Site?

11 Study Activities.

Study Start-up Phase.

Study Maintenance Phase.

Study Completion and Close-Out Phase.

12 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.

13 Management of Study Drugs, Biologics, and Devices.

Study Drugs and Biologics.

Study Devices.

14 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.

15 Global Health and International Trials.

International Clinical Trials.

Ethnic and Racial Differences.

Ethical Issues and Cultural Sensitivities.

Why International Trials Are Important.

International Regulations.


Future Efforts.


Epilogue (Lisa G. Berdan).



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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.

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  • Includes a manual for investigators, research nurses and study coordinators with minimal experience or who are new to clinical research
  • An easy-to-read and open text design using sidebars of examples and information boxes related to the main text
  • Includes a list of Frequently Asked Questions and Glossary


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"This is an excellent guide to how to conduct clinical trials of medical devices and biologics in the light of recent regulatory and clinical developments. The roles and responsibilities of institutional review boards and recent developments regarding subject privacy concerns and regulations are well covered. This manual also provides sample forms and worksheets for data management." (Doody's, 5 August 2011)

"A Clinical Trials Manual from the Duke Clinical Research Institute: Lessons from a Horse Named Jim, 2nd Edition" is a good introduction to clinical research, primarily from the site perspective. The book gives readers a solid foundation of principles and knowledge." (Journal of Clinical Research Best Practices, 8 August 2011)


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