Main description:

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.

Key Features:

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.

This book includes complimentary access to a digital copy on https://medone.thieme.com.

Contents:

Part 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!

Part II What Every Research Coordinator Needs to Know

5 What is Evidence-Based Medicine?

6 Randomized Controlled Trials

7 Observational Studies

8 Surveys

9 Qualitative Studies

10 Principles of Good Clinical Practice and Research Conduct

Part 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

Part 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 Is Important and How to Minimize Loss to Follow-Up

21 How to Close Out a Study

22 Knowledge Dissemination: Getting the Word Out!

Part 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 Studies: Organization and Committees

27 International Research: Challenges and Successes

Part VI A Coordinator's Toolbox

Toolbox A

Toolbox B

Toolbox C

Toolbox D

Toolbox E

Toolbox F1

Toolbox F2

Toolbox F3

Toolbox F4

Toolbox F5

Toolbox F6

Toolbox F7

Toolbox F8

Toolbox F9

Toolbox F10

Toolbox F11

Toolbox G