This eLearning program is designed to provide a practical, realistic context in which to help clinical research professionals learn about conducting clinical trials. Using an interactive case study, the program follows the activities of a fictitious clinical investigator and his staff as they conduct a clinical trial for a fictitious drug.
The program is divided into two modules:
- Module 1 deals with the activities that occur before a clinical trial begins: study preparation and study initiation.
- Module 2 focuses on activities that occur during the trial.
As learners make decisions during the clinical trial, the program explains how each realistic scenario relates to the regulations, guidelines, and practices for conducting clinical trials.
- Managing monitor visits
- Adverse events and safety monitoring
- Study closure
Who should attend?
- Physician assistants
- Nurse practitioners
- Research scientists
- Clinical research professionals
Participants who complete this course should be able to:
- Employ methods for successful subject recruitment, retention and compliance
- Properly apply the informed consent process during a clinical trial
- Record and assess adverse events
- Manage monitoring visits and compliance during the study
- Prepare for an inspection by FDA and describe the FDA inspection process and consequences of an FDA inspection
- Identify the steps in preparing a post-study critique and study closure
The module takes an average of 3.25 hours to complete.