Developing a Successful Clinical Research Program

• Main Author: East, Cara (Author, http://id.loc.gov/vocabulary/relators/aut)
• Corporate Author: SpringerLink (Online service)
• Format: Electronic eBook
• Language: English
• Published: Cham : Springer International Publishing : Imprint: Springer, 2018.
• Edition: 1st ed. 2018.
• Subjects: Medicine.; Medicine/Public Health, general.

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...

Table of Contents:

• 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.