This eLearning module is designed to provide a practical context to help clinical research professionals learn about conducting clinical trials. The Study Preparation module covers the roles and responsibilities of the clinical investigator and others in the study process, regulations and guidelines that govern clinical investigation, and practices that ensure effective, efficient, and ethical study conduct. This module is part of the Clinical Trial Fundamentals eLearning program which uses 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 conduct a clinical trial.
The Clinical Trial Fundamentals eLearning program is divided into three modules:
Module 1: Study Preparation
Module 2: Study Initiation
Module 3: Conducting the Study
As learners make decisions during the clinical trial, the program explains how each scenario relates to the regulations, guidelines, and practices for conducting clinical trials.
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IACET = .3
- Differentiate the roles and responsibilities of the clinical investigator, the study staff, and the sponsor
- Identify the clinical phases of drug development and what is done at each phase
- Outline the clinical trial regulations and Good Clinical Practice guidelines on conducting a clinical trial and essential documents
- List the foundations of ethical conduct in clinical research including its impact on clinical research
- Recognize the history behind human subject protection
- Compare different study designs and discuss the merits of each
- Determine how to develop a study budget
- Roles and Responsibilities
- Good Clinical Practices
- Drug Development Legislation
- Ethical Considerations in Clinical Research
- Study Documents
- Clinical Trial Phases
- Study Design
- Use of Placebo
- Site Evaluation Visit
- Study Budget
- The Contract