Clinical Trials Manual From The Duke Clinical Research Institute (eBook)

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.

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Replacement of Withdrawn, Dropped Out, and Lost to Follow-up Subjects.

Statistical 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 (Lisa G. Berdan).

Glossary.

Index.

"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)