This eLearning bundle includes the Clinical Trial Fundamentals eLearning Program, the Informed Consent: Comprehensive Concepts and Components and Good Clinical Practice modules. The self-paced courses are mobile compatible and learners will have access for one full year to complete them. Learning at your fingertips anywhere, anytime, and at a time that works for you!
The Clinical Trial Fundamentals eLearning Program includes three self-paced modules 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 her 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 Informed Consent: Comprehensive Concepts and Components module provides an in-depth review of the key concepts of informed consent. It explains the components of a complete and appropriate consent form as specified by the International Conference on Harmonisation (ICH) and the US Food and Drug Administration (FDA), as well as guidance for the creation and appropriate wording of these components. It also includes a discussion on the benefits and concerns with electronic informed consent, and presents publications and projects that explore the use of eConsent.
The Good Clinical Practice module will help gain the basic knowledge required to conduct clinical trials, including information about subject safety, regulations, and the practicalities of performing clinical research studies. This module includes information about the recently adopted ICH GCP E6(R2) guideline. Learn through an interactive case study, knowledge checks, and flashcards.
The five modules will take an average of 12.5 hours to complete.