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OPEN Access Clinical Research Operations for Study Coordinators - The Institute for Global Health.

Title: Clinical Research Operations for Study Coordinators

Welcome you to this Open Access course on Clinical Research Operations for Study Coordinators, which was created in 2017 by Faculty of Capacity Development.

On successful completion of this lesson, you will be able to:

1. Understand the key elements of Phase I to IV trials

2. Understand the medicines regulatory process

3. Understand the International Council for Harmonization (ICH) and country-specific good clinical practices (GCP)

4. Discuss ethical standards for conducting clinical trials

5. Identify key elements required for the process of informed consent

6. Identify sponsor side clinical trial team members, their roles and responsibilities

7. Explore the global world of clinical trials and working with virtual teams

8. Understand the roles and responsibilities of the clinical trial site team

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