Clinical Trial Fundamentals: Conducting the Study
The module 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:
- Clinical Trials: Study Preparation
- Clinical Trials: Study Initiation
- Clinical Trials: 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.
The module takes an average of 3 hours to complete.
This eLearning module can be purchased individually or as part of the Clinical Trial Fundamentals eLearning Program or Clinical Trial Management Comprehensive eLearning Bundle.
- 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
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, retention, and compliance
- Properly apply the informed consent process during a clinical trial
- Classify, record, and report adverse events
- Manage monitoring visits
- Describe FDA inspection details including preparation, the inspection process, and consequences for regulatory violation
- Identify the steps in preparing a post-study critique and study closure