| ACRP Course Title | Description | ALL new & current staff functioning as clinical research coordinators | PIs on biomedical research protocols | IND/IDE sponsor investigator protocols (PIs) |
|---|---|---|---|---|
|
GCP Test-Out Challenge (optional module to test out of the curriculum
|
Presented in a game format, this exciting eLearning course assesses GCP knowledge and ability to analyze and apply GCP principles | Optional | Optional | Optional |
|
Introduction to Clinical Trials
|
Reviews medical products development, protection of volunteer patients, and who plays key roles in the development, research, review and approval of medical products | Yes | Yes | Yes |
|
Understanding Clinical Trial Protocols
|
Covers the anatomy of a protocol, hypothesis development, study design, subject safety and data integrity risk considerations, protocol feasibility and protocol amendments | Yes | Yes |
Yes |
|
Ethics and Human Subject Protection
|
Reviews the importance of ethical conduct in clinical trials involving human subjects | Yes | Yes |
Yes |
|
eResearch / Managing Clinical Trials in an Electronic Environment
|
Examines the challenges of working with electronic documents and how to overcome them. How to set up and manage electronic clinical research documents in compliance with US and EU regulations | Yes | Yes |
Yes |
|
GCP for the Experienced Research Coordinator / Assistant
|
Ensure a solid foundation of knowledge of the ICH E6 GCP guidelines, apply appropriate preventative and/or corrective action following investigator responsibility related audit or inspection findings | Yes | X |
X |
| GCP for the Experienced Investigator (85 min) | Ensure a solid foundation of knowledge of the ICH E6 GCP guidelines, apply appropriate preventative and/or corrective action following investigator responsibility related audit or inspection findings | X | Yes | Yes |
|
Mastering the Event Reporting Cycle
|
Guides through the complete event reporting cycle and critical timelines, as defined in ICH E2a and E6 guidelines. Presents why events are reported and their impact on overall subject and patient safety | Yes | Yes | Yes |
|
Risk-Based Monitoring: Essentials for Research Coordinators/ Assistants
|
What is RBM and how is it different from the standard monitoring approach? Examines the impact on CRCs specifically, including new approaches to data management, study budget and contract considerations | Yes | X | X |
|
Risk based Monitoring: Essentials for PIs
|
What is RBM and how is it different from the standard monitoring approach? Examines the impact on CRCs specifically, including new approaches to data management, study budget and contract considerations | X | Optional | IND Pls only |
|
Form FDA 1572
|
Supplies job aids to ease the regulatory burden of handling the FDA 1572: Completion tips, decision trees, FAQs, practice exercises | Yes | Yes | Yes |
| Inspection readiness (90 min) | The course focuses specifically on GCP inspections by the FDA and MHRA but the fundamentals can be applied to any regulatory authority inspection | Yes | Yes | Yes |
| Site Quality Management Tools (45 min) | Master quality-related processes and procedures required to ensure trial compliance | Sr. Managers & Directors; for CRA and CRC optional | Optional | yes |
| ~ 15 hours for recommended courses | ||||