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Clinical Research in Private Practice

Paperback Engels 2026 9780443137501
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Samenvatting

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.

Specificaties

ISBN13:9780443137501
Taal:Engels
Bindwijze:Paperback

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Inhoudsopgave

1. Clinical research: The sequence<br>2. Clinical research personnel and resource utilization<br>3. Role of technology-based solutions for research in private practice interventional spine and pain practice<br>4. Types of clinical research methodology<br>5. Regulatory oversight<br>6. Sponsor relationships<br>7. The audit and monitoring site visit<br>8. Adapting day to day clinical workflow for clinical research<br>9. Meeting research related expectations<br>10. Publication and authorship<br>11. Winning the work<br>12. Role of the National Principal Investigator (PI)<br>13. The role of the research site principal investigator<br>14. The clinical research coordinator<br>15. The Clinical Research Assistant<br>16. Case report forms<br>17. Site qualification forms<br>18. Clinical trial agreements in private practice – importance, role and development<br>19. Institutional review board considerations<br>20. Study budget considerations for private practice<br>21. Site budget considerations for clinical research in private practice<br>22. The trial master file<br>23. Research funding<br>24. Practical research ethics for the private practice physician: From principle to procedure<br>25. Statistical analysis and methodologies in clinical research<br>26. Remote data acquisition and monitoring<br>27. Research monitoring considerations<br>28. Considerations for selecting an electronic data capture platform<br>29. Research liability<br>30. The role of the contract research organization

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€ 193,00
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        Clinical Research in Private Practice