Section I: Getting Started
1. Leadership and management: The Principal Investigator and Research Coordinator
2. Roles: Why a research coordinator is critical
3. Hiring: Characteristics of a highly qualified research coordinator
4. Growth: From 0 to 100, real quick!
Section II: What Every Research Coordinator Needs to Know
5. What is Evidence-Based Medicine?
6. Randomized controlled trials
7. Observational studies (cohort and case series)
9. Qualitative studies
10. Principles of Good Clinical Practice (GCP) and research conduct
Section III: From Idea to Study Start-up
11. Principles of grant writing: Tips for a successful experience
12. Dollars and "sense": A guide to research finances
13. Maintaining records and the trial master file
14. Ethics submissions
15. The basics of research contracts
16. How to start up a study
Section IV: Study Execution and Close-Out
17. Screening and recruiting participants
18. Obtaining informed consent
19. Collecting data: Paper and electronic data capture systems
20. Follow-up: Why it's important and how to minimize loss to follow-up
21. How to close out a study
22. Knowledge dissemination: Getting the word out!
Section V: Advanced Principles of Research Coordination
23. Regulatory trials: Key differences from standard trials
24. How to survive a site audit
25. Monitoring in a clinical study: why and how?
26. Managing large trials: Organization and committees
27. International research: Challenges and successes
Section VI: A Coordinator's Toolbox
Sample Budget Template
Sample Trial Master File TOC
Sample Ethics Checklist
Sample Checklist for Study Startup
Sample Screening Form
Sample Informed Consent Form
Sample Case Report Forms
Sample Study Close-Out Checklist
Sample Checklists for Audit Preparation
A novel and indispensable handbook for clinical research coordinators worldwide.
Because "saying isn't doing; doing is doing": This fourth volume in Mohit Bhandari's series of methodology books, conceived as a transformational guide to executing research for those who coordinate it on a daily basis, focuses not on the design of research projects, but rather on the actual execution of such projects.
- International group of authors and practicing research coordinators with decades of collective hands-on experience
- Includes many crucial, but often neglected, topics such as principles of successful grant writing, working with study budgets, ethics and consent forms, regulatory versus standard trials, coordinating and conducting observational research and randomized clinical trials, and much more
- Many helpful templates and sample forms with checklists, consent forms, budget outlines, and more
A broad readership including scientists, physicians, surgeons, epidemiologists and statisticians, and industry research and development directors will welcome this unique and valuable book.