The Sourcebook for Clinical Research. A Practical Guide for Study Conduct

Table of Contents

1. Foundational Elements and Regulatory Requirements 2. Preparation Before a Clinical Trial Begins 3. Recruiting Clinical Research Subjects 4. Clinical Trial Conduct-A Daily Perspective 5. Organizations With Oversight Responsibility in Clinical Research 6. Exceptional Circumstances in Clinical Research 7. Education and Certification in Clinical Research 8. The Newest Changes in Clinical Research 9. After the Study Has Ended

Authors

Natasha Martien Human Subjects Research regulatory expert. Natasha Martien, MBA, CCRP, SSBBP, CRCP, is a Human Subjects Research regulatory expert with 25 years of clinical research and healthcare management experience at institutes including Johns Hopkins Hospital, The Center for Cardiac and Vascular Research, and Scripps Clinic and Research Foundation. Martien has performed every operational role in clinical research at sites, including: training IRB members, Investigators and Research Coordinators; regulatory management; working for Naan Office of Human Research Protections supporting an IRB; Research Coordination; writing and negotiating clinical trial agreements and budgets; financial management and billing; Coverage Analysis; CTMS acquisition; data analysis; credentialing; Quality Assurance; writing consent forms and study materials; compliance; advertising and recruiting; and the creation of a Clinical Trials Office. Martien has conducted and managed Investigator Initiated, Industry and Grant funded studies in 24 medical disciplines and for all study types, such as INDs, IDEs, biologics, stem cells, behavioral, pilot, observational, chart reviews and clinical trial Phases I through IV. Jeff Nelligan Washington, D.C.-based executive with extensive healthcare oversight, regulatory, and finance experience. Jeff Nelligan, J.D., is a Washington, D.C.-based executive with extensive healthcare oversight, regulatory, and finance experience in three Federal Cabinet Agencies and in the Legislative branch, including: as a Director at the Centers for Medicare and Medicaid Services (CMS) within the U.S. Department of Health and Human Services; as a Managing Director at the U.S. Government Accountability Office (GAO); and, as a senior staffer for three Members of Congress in the U.S. Senate and the U.S. House of Representatives. He is a graduate of Williams College and Georgetown University Law Center.