Clinical Research in Private Practice
Editat de Jason E. Pope, Timothy R. Deer, Steven M. Falowski, Dawood Sayeden Limba Engleză Paperback – 11 feb 2026
- Presents a step-by-step guide for private practice physicians interested in research
- Covers all aspects of integrating research from staffing, logistics, to workflow, funding and more
- Written by practicing physicians in the field of research and clinical best practices
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Specificații
ISBN-13: 9780443137501
ISBN-10: 0443137501
Pagini: 200
Dimensiuni: 152 x 229 mm
Greutate: 0.45 kg
Editura: ELSEVIER SCIENCE
ISBN-10: 0443137501
Pagini: 200
Dimensiuni: 152 x 229 mm
Greutate: 0.45 kg
Editura: ELSEVIER SCIENCE
Cuprins
1. Clinical Research, the Sequence
2. Clinical Research Personnel (CRC, CRA, CFE) and Resource Utilization
3. Role of Technology Based Solutions in Private Practice
4. Types of Clinical Research Methodology (inductive/deductive designs); case series, retrospective review, prospective work, power analysis)
5. Regulatory Oversight
6. Sponsor Relationships
7. The Audit and Monitoring Site Visit
8. Adapting Day to Day Clinical Workflow for Clinical Research
9. Meeting Research Related Expectations
10. Publication and Authorship
11. Winning the Work
12. Role of the National Principal Investigator (PI)
13. Role of the research site Principal Investigator (PI)
14. The Clinic Research Coordinator (CRC)
15. The Clinical Research Assistant (CRA)
16. CRF (Case Report Forms)
17. Site qualification forms (SQF)
18. Clinical Trial Agreement (CTA) considerations
19. Investigational Review Board considerations
20. Study Budget Considerations
21. Site Budget Considerations
22. The Trial Master File (TMF)
23. Research Funding
24. Research Ethics
25. Statistical Analysis Methodologies in Clinica Research (ITT vs MITT)
26. Remote Data Acquisition and Monitoring
27. Research Monitoring Considerations
28. Considerations for selecting an EDC (Electronic Data Capture)
29. Research Liability
30. The Role of the Contract Research Organization (CRO)
2. Clinical Research Personnel (CRC, CRA, CFE) and Resource Utilization
3. Role of Technology Based Solutions in Private Practice
4. Types of Clinical Research Methodology (inductive/deductive designs); case series, retrospective review, prospective work, power analysis)
5. Regulatory Oversight
6. Sponsor Relationships
7. The Audit and Monitoring Site Visit
8. Adapting Day to Day Clinical Workflow for Clinical Research
9. Meeting Research Related Expectations
10. Publication and Authorship
11. Winning the Work
12. Role of the National Principal Investigator (PI)
13. Role of the research site Principal Investigator (PI)
14. The Clinic Research Coordinator (CRC)
15. The Clinical Research Assistant (CRA)
16. CRF (Case Report Forms)
17. Site qualification forms (SQF)
18. Clinical Trial Agreement (CTA) considerations
19. Investigational Review Board considerations
20. Study Budget Considerations
21. Site Budget Considerations
22. The Trial Master File (TMF)
23. Research Funding
24. Research Ethics
25. Statistical Analysis Methodologies in Clinica Research (ITT vs MITT)
26. Remote Data Acquisition and Monitoring
27. Research Monitoring Considerations
28. Considerations for selecting an EDC (Electronic Data Capture)
29. Research Liability
30. The Role of the Contract Research Organization (CRO)