Clinical Trial Fundamentals: Conducting the Study eLearning Module
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This eLearning module is designed to provide a practical context to help clinical research professionals learn about conducting clinical trials. The Conducting the Study module covers finding and enrolling subjects as well as retention of those subjects, the informed consent process, adverse event classification and reporting, monitor visits, FDA inspections, compliance issues, study closure, and activities after the study is complete. 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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Credit Information
ACPE = 3
IACET = .3
IACET = .3
Description
Learning Objectives
After completing this activity, you should be better able to: - Compare methods for successful subject recruitment, retention, and compliance
- Utilize the informed consent process during a clinical trial
- Classify adverse events
- Evaluate the reporting of adverse events
- Determine how to manage monitoring visits
- Identify FDA inspection details including preparation, the inspection process, and consequences for regulatory violation Outline the steps in preparing a post-study critique and study closure
Featured Topics
- Finding Study Subjects
- The Informed Consent Process
- Enrolling the First Subjects
- Classifying and Reporting Adverse Events
- Preparing for a Monitor Visit
- Subject Recruitment Issues
- Retention of Subjects
- Ongoing Subject Recruitment
- Final Subject Selection
- Managing Compliance
- FDA Inspections
- Study Closure
- After the Study