1
Clinical Research Foundations
8 modules
29 lessons
1
What Is Clinical Research?
- 1The Quest for Medical Evidence
- 2Types of Clinical Research
- 3Why Clinical Trials Matter
- Module Quiz10 questions
2
The Ethical Foundations of Human Research
- 1Lessons from History
- 2The Belmont Report and Core Principles
- 3From Principles to Practice
- Module Quiz10 questions
3
The Drug Development Pipeline
- 1Discovery and Preclinical Research
- 2The IND and Clinical Development
- 3Regulatory Review and Approval
- 4Beyond Approval: Post-Marketing
- Module Quiz12 questions
4
Understanding Clinical Trial Phases
- 1Phase I: First-in-Human Studies
- 2Phase II: Proof of Concept
- 3Phase III: Pivotal Trials
- 4Phase IV and Beyond
- Module Quiz12 questions
5
The People Behind Clinical Trials
- 1Sponsors and Contract Research Organizations
- 2Investigators and Site Staff
- 3Ethics Committees and Regulatory Authorities
- 4Participants: The Heart of Clinical Research
- Module Quiz12 questions
6
The Participant Journey
- 1Finding and joining a trial
- 2Understanding Informed Consent
- 3Managing participant visits and ongoing engagement
- 4Study completion and beyond
- Module Quiz10 questions
7
Regulatory Oversight and Quality
- 1The Regulatory Landscape
- 2ICH and International Harmonization
- 3Good Clinical Practice: An Introduction
- 4When Things Go Wrong: Inspections and Enforcement
- Module Quiz10 questions
8
Your Future in Clinical Research
- 1Career roles in clinical research
- 2Education and Certification Pathways
- 3Breaking In: Practical Strategies
- Module Quiz8 questions
Clinical Trial Foundations Final Exam60 questions · 60 min · 80% to pass · 3 attempts