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This scenario-based eLearning course is designed specifically for the Clinical Research Study Coordinators. Based on real-life issues encountered by investigative site teams, this highly focused 7-module training is designed to ensure comprehensive understanding of the key componenets of ICH GCP (including E6 R2). The structure includes two assessment and completion options, depending on experience level. Upon successful completion, a certificate is provided.

Course Learning Objectives  

Upon completion of this scenario-based course, participants will be able to:

• Describe investigator responsibilities in the context of study protocol oversight and GCP compliance
• Recognize critical elements of human subject protection
• Discuss the requirements for investigational product management and maintenance of adequate and accurate records for research trials
• Recognize key requirements for patient safety management and regulatory reporting
• Discuss mandatory critical interactions with Institutional Review Boards (IRBs) or Ethics Committees (ECs)

Key Features Include:

• Comprehensive ICH GCP E6 R2 converage as well as top findings from FDA and EMA
• Focus on practical application of GCP principles and application-based activities
• Glossary of terms, bookmarking tool, ongoing scenario-based "knowledge checks" and post-course exam
• Includes a Barnett certificate of training
• Applicable for global clinical research professionals

Group Pricing Structure:
1-10 Users $199 per user
11-20 Users $179 per user
21-30 Users $169 per user
31-40 Users $159 per user
41+ Users $149 per user