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A practical guide for daily Clinical Research and Clinical Trial conduct
The Sourcebook for Clinical Research: A Practical Guide for Study Conduct is a comprehensive, step-by-step guide for clinical research and clinical trial conduct and operations. In addition to containing key regulatory information from the U.S. Food and Drug Administration, U.S. Department of Health and Human Services and the International Council for Harmonisation Good Clinical Practice, the book has the largest clinical research glossary of any website available today, and has more than 30 Appendix items, including templates, forms, and checklists that readers can customize and download for immediate use. It is a book created to be actionable for busy clinics and human subjects research personnel while keeping them compliant with the regulations.
The book fills a major clinical research gap in the $40 billion annual clinical trial industry. Because even though a single study is invariably complex, with numerous federal regulations, administrative processes, medical procedures, time windows, and specific protocol instructions to follow, there is no comprehensive book for investigators, institutions, and research personnel which covers beginning, intermediate, and advanced topics in clinical research. This book provides a succinct, useful, and up-to-date roadmap to guide research professionals step-by-step through the clinical trial and clinical research labyrinth.
The Sourcebook for Clinical Research audience is every member of an Investigative Team:
- Practitioners who desire to start working in human subjects research;
- Research professionals who want to have one source they can go to in order to stay in compliance with clinical research conduct;
- The seasoned Principal Investigator who occasionally needs answers to questions or/and
- guidance in advanced/complex topics;
- Data Entry Specialists who need to understand the full scope of trials to better understand the
- context and importance of their data input;
- Pharmacists who need understanding of research protocols and IND regulations;
- Institutional Administrators/Directors/Managers, who need to know the myriad of federal regulations and state laws and to have a sense of certainty the trials conducted under their purview are done so compliantly;
- Institutional Review Board members, who need expertise in regulations and ICH GCP to make determinations for the approval, revision or denial of research studies that are submitted;
- Office of Human Research Protections personnel within Institutions who must know the federal regulations and ICH GCP at an expert level.
This guide is indispensable by allowing clinical research team members and sites to have at their fingertips compliant practical guidance and documents to manage their research studies at an expert level.
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About the Authors:
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, 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.