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Foreword | |
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Preface | |
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List of Abbreviations | |
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Lessons from a Horse Named Jim and Other Events in History Affecting the Regulation of Clinical Research | |
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The Process: Developing New Drugs, Biologics, and Devices | |
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The Drug Development Process | |
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Developing New Devices | |
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Postmarketing Surveillance of Drugs, Biologics, and Devices | |
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Good Clinical Practice and the Regulations | |
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Good Clinical Practice | |
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Responsibilities in the Code of Federal Regulations | |
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Where to Obtain Information and Guidance for the Regulations and GCP | |
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Informed Consent and the Regulations | |
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What Is Informed Consent? | |
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Ethical Codes Regarding Informed Consent | |
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Regulatory Requirements for Informed Consent | |
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The Informed Consent Process | |
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Institutional Review Boards | |
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What is an Institutional Review Board? | |
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IRB Activities | |
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Types of IRB Review | |
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Communication between IRBs and Investigators | |
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Communication between IRBs and Study Sponsors | |
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IRB Records and Reports | |
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Accreditation of IRBs | |
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Registration | |
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Adverse Events and Unanticipated Problems Involving Risks to Subjects or Others | |
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Why Collect Adverse Event Data? | |
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Adverse Events | |
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Unanticipated Problems Involving Risks to Subjects or Others | |
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Investigator Responsibilities | |
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IRB Responsibilities | |
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Sponsor Responsibilities | |
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Monitoring, Audits, and Inspections | |
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Monitoring Plan | |
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On-Site Monitoring | |
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In-House Monitoring | |
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Audits and Inspections | |
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The Principal Investigator, the Clinical Research Coordinator, and the Study Site | |
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The Principal Investigator | |
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Staffing to Support Clinical Trials | |
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Space and Resource Needs | |
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The Local Institutional Review Board | |
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The Protocol | |
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Common Components of a Protocol | |
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Background and Rationale | |
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Study Organization | |
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Objectives/Endpoints | |
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Study Design | |
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Study Population | |
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Study Treatment Plan | |
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Safety Assessment, Management, and Reporting | |
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Replacement of Withdrawn, Dropped Out, and Lost to Follow-up Subjects | |
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Statistical Aspects | |
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Subject Data and Record Retention | |
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Monitoring | |
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Study Feasibility: Reviewing a Specific Protocol | |
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Reviewing a Specific Protocol | |
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Should We Do this Study at Our Site? | |
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Study Activities | |
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Study Start-up Phase | |
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Study Maintenance Phase | |
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Study Completion and Close-Out Phase | |
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Study Documents/Essential Documents | |
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Documents at Study Start-Up | |
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Documents While the Study is in Progress | |
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Documents at Study Close-out | |
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Maintaining Your Site Study File | |
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Management of Study Drugs, Biologics, and Devices | |
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Study Drugs and Biologics | |
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Study Devices | |
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Managing Clinical Trial Data | |
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HIPAA, the Privacy Rule, and Clinical Trial Data | |
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Guidelines and Regulations Regarding Clinical Trial Data | |
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Study Site Responsibilities Regarding Clinical Trial Data | |
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Source Document Verification of Clinical Trial Data | |
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Release of Protected Medical Information | |
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Confidentiality of Clinical Trial Data | |
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Endpoint Adjudication | |
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Global Health and International Trials | |
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International Clinical Trials | |
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Ethnic and Racial Differences | |
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Ethical Issues and Cultural Sensitivities | |
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Why International Trials Are Important | |
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International Regulations | |
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Concerns | |
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Future Efforts | |
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Appendices | |
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Epilogue | |
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Glossary | |
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Index | |