Description
Description:
Clinical Trials is an ideal program for all novice clinical researchers, those interested in the profession, or those indirectly involved in clinical trials. This course provides the foundational knowledge upon which one can develop his/her competence as a clinical research professional. In this course, participants will be trained on how to design and carry out clinical trials. This course provides them with essential skills to evaluate options, make good design choices, and implement them within a trial. participants will learn to control for bias, randomize participants, mask treatments and outcomes, identify errors, develop and test hypotheses, and define appropriate outcomes. They will also learn the guiding principles and develop the essential skills to ethically and conscientiously recruit, obtain consent from, and retain trial participants.
Training outcomes:
- Define clinical trial outcomes
- Analyze the study and site activities and requirements
- Explain the core ethical principles of clinical research
- Discuss how the research subject’s safety, rights and welfare are protected in clinical trials
- Describe the development process for medical products and the related regulations
- Determine good clinical practices for ensuring the safety of the research subject and the validity of a clinical trial
- Evaluate and select clinical trial designs
- Implement bias control measures
- Randomize participants into groups
Training issues
- Introduction to clinical trials
- Overview of phase I and II trials
- Interventions, participants, and outcomes
- Basic trial designs
- Sample size and power
- Proposal writing
- Recruitment, retention, and adherence
- Sampling and randomization
- Intervention and data collections
- The risk of bias
- Data analysis overview
- Writing the report
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