A clinical trials manual from the Duke Clinical Research Institute : lessons from a horse named Jim /
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| Author / Creator: | Liu, Margaret B. |
|---|---|
| Edition: | 2nd ed. |
| Imprint: | Chichester, West Sussex, UK ; Hoboken, NJ : Wiley-Blackwell, 2010. |
| Description: | 1 online resource (xviii, 406 pages) : illustrations |
| Language: | English |
| Subject: | |
| Format: | E-Resource Book |
| URL for this record: | http://pi.lib.uchicago.edu/1001/cat/bib/12751348 |
Table of Contents:
- Foreword
- 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
- OnâÇôSite Monitoring
- InâÇôHouse 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- Replacement of Withdrawn, Dropped Out, and Lost to FollowâÇôup Subjects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 StartâÇôup Phase
- Study Maintenance Phase
- Study Completion and CloseâÇôOut Phase
- 12. Study Documents/Essential Documents
- Documents at Study StartâÇôUp
- Documents While the Study is in Progress
- Documents at Study CloseâÇôout
- 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
- Glossary
- Index
