Developing a Successful Clinical Research Program

This unique book is designed to help a medical team become a clinical research team. It includes practical information and tips for the initial stages of clinical research: building a team, negotiating a contract, developing a budget, and writing and improving a patient consent. Chapters describing...

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Bibliographische Detailangaben
1. Verfasser: East, Cara (VerfasserIn)
Format: Elektronisch E-Book
Sprache:Englisch
Veröffentlicht: Cham : Springer International Publishing, 2018.
Ausgabe:1st ed. 2018.
Schlagworte:
Medicine.
ISBN:9783319546933
Online-Zugang: Volltext
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Inhaltsangabe:
  • Why Do Clinical Research?- How Clinical Research Should Never Have Been Done: Ethical Measures for Protection and Respect
  • Choosing Studies
  • Starting Clinical Research
  • Developing a Budget
  • Negotiating a Contract
  • Writing a Great Informed Consent (IC)
  • Starting the Study
  • Regulatory Startup
  • Recruiting
  • Getting Subjects through the Door
  • The Screening Visit
  • Follow-up Visits
  • Maintaining Subject Retention and Avoiding Study Fatigue
  • Adverse Events (AE's) and Protocol Deviations
  • Contact Research Organizations (CRO's) and Monitors
  • Annual Review and Financial Disclosures
  • Finishing a Study
  • Staff Training and Incentives
  • Study Closeout
  • Acing an Audit
  • Expanding the Team
  • Epilogue: Watching Medicine Evolve
  • Appendices.

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