Clinical Trials: Conducting the Study
This eLearning module is part of the Clinical Trial Fundamentals eLearning Program and is 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 conduct a clinical trial.
The Clinical Trials 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.
This ICH E6 R2 GCP Investigator Site Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma Inc. as necessary to enable mutual recognition of GCP training among trial sponsors.
- Subject recruitment, selection, retention, and compliance
- Applying the informed consent process during a clinical trial
- Classifying, recording, and reporting adverse events
- Managing monitoring visits
- FDA inspections
- Post-study critique and study closure
Who should attend?
This module is designed for those working for investigative site teams, sponsors, or CROs, including clinical investigators, research coordinators, office coordinators, nurses, physician assistants, clinical research coordinators, and other professional involved in clinical trials.
- Physician assistants
- Nurse practitioners
- Research scientists
- Clinical research professionals
Upon completion of this module, learners should be able to:
- Appropriately employ methods for successful subject recruitment, selection, retention, and compliance
- Properly apply the informed consent process during a clinical trial
- Classify, record, and report adverse events
- Manage monitoring visits
- Describe how to prepare for an FDA inspection, the process of the inspection, and potential consequences for being noncompliant
- Identify the steps in preparing a post-study critique and study closure
The module takes an average of 3 hours to complete.