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.
- Ethics and regulations in clinical research
- Informed consent process
- Clinical trial site preparation
Who should attend?
- Physician assistants
- Nurse practitioners
- Research scientists
- Clinical research professionals
Participants who complete this course should be able to:
- Differentiate the roles and responsibilities of the clinical investigator, the study staff, and the sponsor with regard to a clinical trial
- Identify the clinical phases of drug development and what is done at each phase
- Describe the role and responsibilities of the Institutional Review Board/Independent Ethics Committee with regard to a clinical trial
- Discuss the regulations and Good Clinical Practice guidelines on conducting a clinical trial
- Explain the foundations of ethical conduct in clinical research including its impact on clinical research
- Apply the informed consent process during a clinical trial
- Explain the history behind human subject protection
- Prepare a site to conduct a clinical study
- Organize a site for study initiation, the study initiation meeting, and the investigator meeting