Clinical Trial Fundamentals eLearning Program
This program is designed to provide a practical context to help clinical research professionals learn about conducting clinical trials. Using an interactive case study with realistic scenarios designed to illustrate the learning points, the program follows the activities of a fictitious clinical investigator and their staff as they prepare for, initiate and conduct a clinical study. As learners make decisions during the clinical trial, the program illustrates how clinical trial regulations and guidelines impact each situation, and the complex details of clinical trial study management.
The online program includes three self-paced modules that can be accessed anytime, anywhere for one year.
- Responsibilities of the investigator and sponsor
- Study documents and Study Design
- Clinical trial phases
- Use of placebo
- International Conference on Harmonisation
- Drug Development Legislation
- Ethical considerations in clinical research
- Responsibilities of the study staff
- The site evaluation visit
- The study budget and contract
- FDA Form 1572
- Financial disclosure
- Institutional Review Board
- Informed consent and HIPAA
- Study initiation documents
- The investigator meeting and the study initiation meeting
- Investigator study files
- Subject recruitment, selection, retention, and compliance
- Applying the informed consent process during a clinical trial
- Classifying, recording, and reporting adverse events
- Managing monitoring visits
- FDA inspections
- Post-study critique and study closure
This eLearning bundle includes the Clinical Trial Fundamentals eLearning Program and the Informed Consent: Comprehensive Concepts and Components module.
Learn about the key concepts of informed consent including components of a complete and appropriate consent.
Explore the fundamentals of why and how to incorporate patient focus and build organization-wide capabilities.