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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 | |