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1 TABLE OF CONTENTS Acknowledgments... xi Introduction... xiii 1 The Clinical Research Coordinator (CRC)... 1 Background and Training of the CRC...1 Personality and Skills... 2 Where Do CRCs Work?... 2 CRC Responsibilities... 4 Problems and Opportunities Institutional Review Boards (IRBs) and Data Safety Monitoring Boards (DSMBs)...9 Introduction... 9 Types of IRBs...10 IRB Membership...10 IRB Operations...11 IRB Responsibilities...11 Vulnerable Subjects...12 State and Local Regulations...13 IRB Review of Proposed Research...13 Materials Submitted to the IRB by an Investigator...13 IRB Deliberations...15 Investigator Reporting Responsibilities...15 Continuing Review of a Research Study...16 Expedited Review...17

2 Conflict of Interest...17 IRB Registration...18 FDA Guidance Documents for IRBs...18 CRC Duties and Responsibilities...19 Data Safety Monitoring Boards (DSMBs)...19 Key Takeaways...21 Case Study: Conflict of Interest Discussion Informed Consent...23 Introduction Defining Informed Consent Preparing the Informed Consent Document Obtaining Informed Consent...28 The Consent Process...30 Exceptions from Consent...31 Conclusion...34 Key Takeaways Regulations and Good Clinical Practices (GCPs) Introduction...37 FDA Regulations for Clinical Trials...37 ICH Guideline for Good Clinical Practice...38 FDA Guidelines and Information Sheets...38 FDA Compliance Program Guidance Manuals...39 NIH-Regulated Research...39 FDA Bioresearch Monitoring Program (BIMO)...40 Good Clinical Practice (GCP)...40 Contacting the FDA...41 HIPAA...41 HIPAA Authorization...41 Protected Health Information (PHI) Recruitment of Study Subjects Obtaining Informed Consent under HIPAA... 45

3 The Declaration of Helsinki (1964) The Belmont Report (1979)...46 Key Takeaways An Overview of Research...49 Introduction...49 Pre-Clinical Research...49 Clinical Trials Notes on Studies in Women and Children...56 Summary Key Takeaways Devices and Biologics...59 Biologics and Vaccines...61 Key Takeaways Standard Operating Procedures (SOPs)...65 Writing SOPs...66 Approval, Training and Implementation...71 SOPs for Investigative Sites...71 Key Takeaways Case Study: Why do we need SOPs? Preparing for a Study...79 Introduction Site Assessments (Site Evaluations) How to Succeed in Getting Studies...81 Protocol Feasibility...82 Grants, Budgeting and Contracts...83 Investigative Site Study Files...86 Storage of Study Materials...90 Study Documents...91 Financial Disclosure...92 Investigator Meetings...94

4 Study Initiation Meetings...95 Working with CRAs...96 Other Sponsor Interactions Shipping of Biological Samples Key Takeaways Protocols Introduction Protocols Protocol Complexity Protocol Amendments During the Study Key Takeaways Case Study: Protocols Case Report Forms (CRFs) and Electronic Data Capture (EDC) Case Report Forms (CRFs) Electronic Data Capture (EDC) Good, High-Quality Data Internal Quality Assurance Key Takeaways Case Study: The Cost of Errors Investigational Product Accountability Responsibilities During a Clinical Trial Key Takeaways Case Study: Investigational Product Accountability Working with Study Subjects Recruitment of Study Subjects New Strategies for Subject Recruitment Scheduling Subjects...143

5 Retention of Study Subjects Subject Compliance Key Takeaways Study Closure Introduction Reasons for Study Closure Closure Procedures Investigator s Final Report to the Sponsor and the IRB Administrative Issues Record Retention Post-Study Critique Key Takeaways Adverse Events (AEs) and Safety Monitoring Regulations Definitions Adverse Events (AEs) on Marketed Products Adverse Events (AEs) in Clinical Trials Investigator Reporting Responsibilities Sponsor Responsibilities Differences Between Clinical Studies and Clinical Practice Assessing the Relationship of an AE to the Study Drug Common Reporting Problems Key Takeaways Case Study: Caught in the Middle with Adverse Events Audits Sponsor Audits of Investigative Sites IRB Audits of Investigative Sites FDA Audits of Investigative Sites Consequences Key Takeaways Case Study: Audit Attitude...191

6 Afterword Appendix A Acronyms Appendix B Glossary Appendix C Appendix D Resources Sample Forms, Checklists and Logs Appendix E Title 21 Food and Drugs Part 11 Electronic Records; Electronic Signatures Part 50 Protection Of Human Subjects Part 54 Financial Disclosure by Clinical Investigators Part 56 Institutional Review Boards Part 312 Investigational New Drug Applicaion Part 314 Applications for FDA Approval to market a new drug Part 600 Biological Products: General Part 601 Licensing Part 610 General Biological Products Standards Part 812 Investigational Device Exemptions Part 814 Premarket Approval of Medical Devices Appendix F Appendix G Harmonized Tripartite Guideline for Good Clinical Practice Practice Examination Index About CenterWatch About the Author

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