Course Recognition
Acknowledgements
Source Material
Some of the material used in this module has been kindly provided by the East African Consortium for Clinical Research (EACCR).
Reviewers
This module has been reviewed by:
Steve Wandiga – Kenya Medical Research Institute (KEMRI)/Centers for Disease Prevention and Control (CDC) – KEMRI/CDC Research and Public Health Collaboration, Kisumu, Kenya.
Andy Burke – CTSU, Oxford University.
Course Objectives and Contents
- the basic concepts of clinical research e.g. what it is, how it differs from standard care and why it is undertaken
- the purpose of ethics in research, what informed consent is and why it is necessary
- five of the most commonly used study designs
- how high ethical standards, data quality and uniformity are maintained in a study
Contents
– Introduction: this section provides an overview of:
- A definition of clinical research
- How does clinical research differ from standard care
- Why is clinical research carried out
– Research Participants and Ethical Practices: this section provides an overview of:
- The main principles of research ethics
- Informed consent and why we need it
- Why people participate in research and the benefits and risks
– Types of Clinical Studies: this section provides an overview of:
- Cohort studies
- Case control studies
- Cross sectional surveys
- Case reports
- Clinical trials
– Maintaining high ethical standards, data quality and uniformity in a study: this section provides an overview of:
- Standard operating procedures
– Key points to remember
– References and Resources
This section provides the references used in this course and resources that you may find useful for further reading.
– Quiz
This section provides questions that will allow you to test what you have learned from the course.
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