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This course was designed and developed by FCD in collaboration with the Global Health Clinical Consortium (GHCC), Strathmore University, Kenya, and the Institute for Global Health at the University of Siena, Italy. The course is specifically for Study Coordinators, and those working in related roles, who conduct clinical trials in Low-and Middle-Income Countries |
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Duration: Certification: Languages: Related Resources: QUESTION SETTING AND STUDY DESIGN STUDY IMPLEMENTATION AND OPERATIONS |
Target Audience
This course is designed for those who currently work in clinical research as a Study Coordinator. It is also suitable for anyone who wishes to work in this field, including investigators, nurses, scientists and clinicians, clinical research associates and clinical monitors, as well as those without formal qualifications.
Objectives
At the end of this course, successful participants will be able to do the following:
- Prepare sites for clinical trial start up through an overall understanding of the clinical trial process from project management to research design and protocol development;
- Demonstrate the ability to effectively conduct clinical trials using patient recruitment and retention approaches, data management, data monitoring, pharmacovigilance, safety reporting and good financial practices;
- Design and maintain the quality system of a clinical trial through implementing SOPs, handling audits and inspections, as well as other aspects of QA and QC;
- Identify and address key challenges in managing research sites including developing and maintaining capacity, doing community engagement and managing grants;
- Develop people management skills and techniques that will be useful in working with internal colleagues and external partners
Course contents
Module |
Title |
Action |
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Module 1 |
Introduction to Clinical Research Operations |
Begin module |
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Module 2 |
Data Management and Biostatistics |
Begin module |
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Module 3 |
Study Design and Protocol Development |
Begin module |
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Module 4 |
Conducting a Clinical Trial (Part 1) |
Begin module |
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Module 5 |
Conducting a Clinical Trial (Part 2) |
Begin module |
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Module 6 |
Project and Financial Management (Part 1) |
Begin module |
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Module 7 |
Project and Financial Management (Part 2) |
Begin module |
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Module 8 |
Working with External Partners |
Begin module |
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Module 9 |
Quality Systems, Audits and Inspections |
Begin module |
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Module 10 |
Pharmacovigilance |
Begin module |
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CERTIFICATE OF ATTENDANCE |
Certificate |
Acknowledgements
The following people made significant contributions to the design, development and delivery of this course:
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Ghiorghis Belai Sutinder Bindra Simon Bolo Gavin Chait Sue Ann Costa Clemens Helen Demarest Shaantanu Donde Dawit A Ejigu Tim Grant Soumya Hazra Lisa Maria Hodel |
Renee Holt Sandra Johnson Jennifer Lehrman Admasu T Mamuye Emanuele Montomoli Pamela Nabeta Alice Neequaye Bernhards Ogutu Brenda Okech Florence Oloo Russ Orrico |
Victorine Owira Thy Pham Swapnali Raut Kathryn Rutkowski Bethseba Siddondo Mercury Shitindo Mahnaz Vahedi Jim Whalen Jeremy Whitty Sinéad Whitty Gabriela Zepeda Orozco |
Copyright
© FCD 2017
This license allows re-users to distribute, remix, adapt, and build upon the material in any medium or format for non-commercial purposes only, and only so long as attribution is given to the creator. If you remix, adapt, or build upon the material, you must license the modified material under identical terms.
How to Cite:
Cite this course as Clinical Research Operations for Study Coordinators, by FCD, as hosted on The Global Health Network, licensed under CC BY-NC-SA.
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