A Comprehensive and Practical Guide in Clinical Trials
Autor Brenda Wrighten Limba Engleză Paperback – apr 2027
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Specificații
Notă biografică
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.
Cuprins
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
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