Introduction to Clinical Trials
Course Description This workshop provides a comprehensive introduction to the world of clinical trials, equipping healthcare professionals…
- 7
- 6h
- 1
Course Description
This workshop provides a comprehensive introduction to the world of clinical trials, equipping healthcare professionals and research staff with the knowledge and skills necessary to engage in clinical research responsibly and effectively.
Through three structured modules, participants will gain a strong foundation in the fundamentals of clinical trials, regulatory and ethical frameworks, and the key roles required for successful trial conduct.
- Module 1 introduces learners to the importance, history, and structure of clinical trials, covering levels of evidence, trial classifications, and trial phases.
- Module 2 emphasizes regulatory compliance and ethical considerations, exploring historical violations, ethical principles, informed consent, IRB oversight, and handling research misconduct.
- Module 3 highlights the essential skills and roles of clinical trial professionals, with a focus on teamwork, responsibilities, and the central role of the Clinical Research Coordinator.
By the end of this workshop, participants will have the necessary knowledge to appreciate the scientific, ethical, and operational aspects of clinical research, while fostering a culture of integrity and collaboration in clinical trial practice.
What Will You Learn?
- Learning Objectives:
- Module 1: Introduction to Clinical Trials
- By the End of Module 1 of this Workshop, learners will be able to:
- Understand the importance of clinical trials.
- Develop a general understanding of the levels of evidence and the different phases of clinical trials.
- Appreciate the history behind clinical research and its impact of scientific advances
- Understand the different classifications of clinical trials
- Elaborate on the phases of clinical trials.
- Module 2: Regulatory Compliance and Ethical Considerations
- By the End of Module 2 of this Workshop, learners will be able to:
- Explore the definition of ethics in clinical research.
- Identify the steps of the ethical decision-making process.
- Understand the concept of guidelines compared to Standard Operating Procedures used in Clinical Trials.
- Understand the Different Ethical Principals that Apply to Clinical Research.
- Explore ethical violations in history and apply the ethical principles to each scenario.
- Develop an understanding of the existing guidelines that regulate research in humans.
- Understand the role of the IRB in regulating local clinical trials.
- Describe the components of informed consent and its importance in protecting patients’ rights and welfare.
- Discuss the different types of Informed Consent and what are the indications of using them.
- Discuss the ethical dilemma in using Placebos in clinical trials.
- Understand the process of addressing misconduct and violations in clinical trials.
- Module 3: Key Skills & Roles for Clinical Trials Professionals
- By the End of Module 3 of this Workshop, learners will be able to:
- Develop an understanding of the life cycle of a clinical trial.
- Understand the basic skills required to take up a role as clinical trials professional.
Course Curriculum
Introduction to Clinical Trials Module 1
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PART 1: Introduction to Clinical Trials
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PART 2: Introduction to Clinical Trials
Introduction to Clinical Trials Module 2
Introduction to Clinical Trials Module 3
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