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Wright

A Comprehensive and Practical Guide in Clinical Trials

Medium: Buch
ISBN: 978-0-443-48553-4
Verlag: Elsevier Science
Erscheinungstermin: 01.04.2027
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The Comprehensive and Practical Guide in Clinical Trials, Second Edition offers a thorough update to the foundational handbook on clinical trial conduct. It reflects the evolving landscape of clinical research since 2017, incorporating new regulatory guidelines, innovations in device trials, and the shift to electronic data capture and management. This resource addresses the needs of clinical trial staff by detailing processes essential to successful trial execution. Covering all aspects of clinical research, the book includes chapters on trial phases, site selection, regulatory requirements, contracts, protocol development, informed consent, and data management. New chapters focus on project management, electronic source documents, and pharmacy operations. Each chapter integrates practical tools such as checklists, templates, and case studies to facilitate understanding and application. This handbook uniquely supports the entire clinical trial team—including investigators, coordinators, pharmacists, data managers, and regulatory personnel—by clarifying roles and responsibilities and illustrating how their tasks interconnect. Its accessible style and comprehensive scope make it an indispensable guide for planning, conducting, and closing clinical trials effectively and in compliance with international standards.

Produkteigenschaften

  • Artikelnummer: 9780443485534
  • Medium: Buch
  • ISBN: 978-0-443-48553-4
  • Verlag: Elsevier Science
  • Erscheinungstermin: 01.04.2027
  • Sprache(n): Englisch
  • Auflage: 2. Auflage 2027
  • Produktform: Kartoniert
  • Seiten: 200
  • Format (B x H): 152 x 229 mm
  • Ausgabetyp: Kein, Unbekannt
  • Vorauflage: 978-0-12-804729-3

Themen

Autoren/Hrsg.

Autoren

Brenda Wright (Registered Nurse/Medical Technician) started her career in Research at an Early Phase Unit in George in 2005. There she gained experience as study coordinator, Manager Clinical Planning, Manager Transit Laboratory and Clinical Trial Assistants. Experience includes: Healthy Volunteer, Bio-equivalent, First into Human, Restless Legs, Parkinson’s disease, Alzheimer’s disease, Schizophrenia, Diabetes, COPD, Asthma, Osteo Arthritis, Rheumatoid arthritis, various skin diseases, TB, HIV, Sickle Cell in children and adolescents and Cancer. Brenda joined the CRC in April 2014 as Project Manager and the Research Facility Ward Manager. She has since been appointed as Operations Manager: Pharma-Lead Projects.

1. Introduction to Clinical Trials
2. Clinical Trial Phases
3. Setting Up of Site, Site Assessment and Selection
4. Regulatory Requirements
5. Contracts and Budget
6. Protocol, Investigator Brochure and Informed Consent Document
7. Project Management
8. Recruitment and Retention
9. Training
10. Pharmacy Management (Investigational Product/Device Management)
11. Data Management
12. Electronic Source Document Design
13. Paper Source Document Design and Clinical Conduct
14. Collecting, Processing and Shipment of Biological Samples
15. Quality Management
16. Monitoring, Close-Out Visits and Archiving
17. Audits and Inspections