Clinical Trials Manual from the Duke Clinical Research Institute Lessons from a Horse Named Jim

ISBN-10: 1405195150

ISBN-13: 9781405195157

Edition: 2nd 2010

List price: $126.95 Buy it from $82.63
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Description:

As the number of clinical trials grows, there is an increasing need for education and training in the field. This edition details new laws and regulations in protecting children participating in clinical trials and how a new focus on privacy of individual health information in the U.S. has changed how medical records are handled.
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Book details

List price: $126.95
Edition: 2nd
Copyright year: 2010
Publisher: John Wiley & Sons, Limited
Publication date: 1/22/2010
Binding: Paperback
Pages: 424
Size: 6.75" wide x 9.50" long x 1.00" tall
Weight: 1.980
Language: English

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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