Full Description
Clinical research is the tip of the spear for innovation and central in the development of improving safety and efficacy for patient centric care. Unfortunately, clinical research in academic practices is bogged down by inefficiency and infrequent regulatory oversight, thus leaving physicians unable to meet the clinical and research needs for driving innovation. Private practice is a valid practice cohort that can effectively, reliably, and reproducibly perform study related activities, for both FDA and non-FDA regulated studies, both industry-sponsored or investigator-initiated.Clinical Research in Private Practice fills a gap and provides a playbook for how to incorporate clinical research in a validated, safe, and compliant manner, allowing a needed meaningful contribution to the medical space, while concurrently maintaining fiduciary responsibility. Written for physicians by physicians.
Contents
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)
