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

[Title]
A Clinical Trials Manual from the Duke Clinical Research Institute:
Lessons from a Horse Named Jim
2nd Edition
[Authors and Affiliations]
Margaret B. Liu
Principal, Clinical Trials Consulting, Singapore
(Formerly Manager of the Monitoring Group at the Duke Clinical Research Institute, Durham, North Carolina, USA)
Kate Davis
Clinical Research Communications Specialist, Duke Clinical Research Institute,
Durham, North Carolina, USA


[Main copy]
"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 biologicsThe role and responsibilities of Institutional Review Boards, andRecent 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.

[Titles of Related Interest]
A Concise Guide to Clinical Trials
Allan Hackshaw, 978–1–4051–6774–1
Clinical Trials Handbook
Shayne Cox Gad, 978–0–471–21388–8
Randomized Clinical Trials: Design, Practice and Reporting
David Machin and Peter Fayers, 978–0–471–49812–4


Spis treści:
Foreword by Robert A. Harrington
Preface
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
Registration
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
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
Stat istical Aspects
Subject Data and Record Retention
Monitoring
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
Concerns
Future Efforts
Appendices
Epilogue by Lisa G. Berdan
Glossary
Index

Nota biograficzna:
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.

Okładka tylna:
[Title]
A Clinical Trials Manual from the Duke Clinical Research Institute:
Lessons from a Horse Named Jim
2nd Edition
[Authors and Affiliations]
Margaret B. Liu
Principal, Clinical Trials Consulting, Singapore
(Formerly Manager of the Monitoring Group at the Duke Clinical Research Institute, Durham, North Carolina, USA)
Kate Davis
Clinical Research Communications Specialist, Duke Clinical Research Institute,
Durham, North Carolina, USA


[Main copy]
"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 inclu de 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 biologicsThe role and responsibilities of Institutional Review Boards, andRecent 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.

[Titles of Related Interest]
A Concise Guide to Clinical Trials
Allan Hackshaw, 978–1–4051–6774–1
Clinical Trials Handbook
Shayne Cox Gad, 978–0–471–21388–8
Randomized Clinical Trials: Design, Practice and Reporting
David Machin and Peter Fayers, 978–0–471–49812–4