Fundamentals of GCP

A modern, exciting online, on-demand course covering the Good Clinical Practice (GCP) requirements of both sponsors and the investigator site

• Based on ICH GCP Guidelines E6(R2).
• Needs no prior knowledge of GCP.
• Ideal as core basic training.
• Suitable as a GCP refresher for sponsor and investigator site personnel.
• A great course to provide GCP knowledge to those assisting with clinical trials, administrators, ethics committees and regulators.
• Complete eight main sections to reach a final test.
   â€“    GCP Essentials and Principles
   â€“    Pre-study Activities – Protocol and Trial Conduct
   â€“    Participant Protection and Safety
   â€“    Data Quality and Reliability
   â€“   Risk Management and Trial Monitoring
   â€“    Documentation and Trial Files
   â€“   Audit, Inspections and Closure
• Narrated, or read-only.
• Takes around 2 hours – stop and start at any time.
• Interactions and quiz questions to maintain interest.
• Personalised with first name.
• Additional resources form part of the course including e-books entitled ‘Essential GCP’, ‘Indexed ICH GCP Guidelines’, ‘A Guide to Informed Consent’ and ‘Risk Management in Clinical Trials’.
• Pass the final test (80% or more) to be awarded certification.
• Opportunity to repeat incorrectly answered questions in the event of a test score lower than 80%. • Available as fully serviced training (registration, activity monitoring, progress reporting, certification, helpline) or run it on your own learning management system.

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