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Ethics and Regulatory Affairs in Clinical Research
Ethics and Regulatory Affairs in Clinical Research
Curriculum
6 Sections
16 Lessons
10 Weeks
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Module 1: Foundations of Ethics in Clinical Research
4
1.0
Chapter 1: Introduction to Ethical Principles – Dive deep into the core ethical principles that govern clinical research, including respect for persons, beneficence, and justice.
1.1
Chapter 2: Historical Ethical Dilemmas and Lessons Learned – Explore pivotal moments in clinical research history that shaped the current ethical landscape, featuring engaging storytelling to bring the past to life.
1.2
Chapter 3: Applying Ethics to Modern Clinical Trials – Learn how to apply ethical principles in contemporary research settings through interactive scenarios and real-life case studies.
1.3
🎦
Module 2: Regulatory Frameworks and Compliance
3
2.0
Chapter 1: Global Regulatory Bodies and Their Roles – Understand the role and influence of major regulatory bodies like the FDA, EMA, and others across the globe.
2.1
Chapter 2: Understanding FDA Regulations – Delve into the specifics of FDA regulations with easy-to-understand explanations and expert insights.
2.2
Chapter 3: Compliance Best Practices in Clinical Trials – Master the art of compliance with best practices that ensure safety and efficacy in clinical trials.
Module 3: Informed Consent Process
3
3.0
Chapter 1: Designing and Implementing an Informed Consent Form – Get hands-on experience designing effective and ethical informed consent forms using interactive templates.
3.1
Chapter 2: Ethical Considerations in Vulnerable Populations – Examine the complexities of working with vulnerable groups such as children, elderly, or economically disadvantaged populations.
3.2
Chapter 3: Legal Implications of Informed Consent – Navigate the legal landscape of informed consent and understand its implications in clinical research settings.
Module 4: Safety Monitoring and Reporting
3
4.0
Chapter 1: Establishing Safety Monitoring Plans – Learn how to establish robust safety monitoring systems that ensure participant safety and regulatory compliance.
4.1
Chapter 2: Roles of Safety Monitoring Committees – Become proficient in recognizing and reporting adverse events quickly and accurately.
4.2
Chapter 3: Adverse Event Reporting – Engage with ethical dilemmas related to safety monitoring and learn how to resolve them effectively.
Module 5: Data Management and Quality Assurance in Clinical Trials
3
5.0
Chapter 1: Fundamentals of Clinical Data Management – Gain valuable insights into preparing for audits, with step-by-step guides and expert tips.
5.1
Chapter 2: Implementing Quality Assurance Protocols – Understand the ethical nuances in preparing for and conducting inspections.
5.2
Chapter 3: Ethical Considerations in Data Management – Learn the best practices for addressing findings and implementing recommendations following audits.
Quiz
1
6.1
Ethics and Regulatory Affairs in Clinical Research: Quiz
15 Questions
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