This second 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 United States has changed how medical records are handled. This second 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 United States has changed how medical records are handled. 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 Replacement of Withdrawn, Dropped Out, and Lost to Follow up Subjects.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.