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This introductory course provides learners with the necessary background required when working in a Good Clinical Practice (GCP) environment. Designed for those not directly interfacing with clinical research sites, the course includes application-based examples and the rationale behind GCP principles. Upon successful completion, a certificate is provided.
Course Learning Objectives
Describe core principles of GCP and the application of these concepts in clinical research
Apply the basics of the International Council for Harmonization Good Clinical Practice (ICH GCP) including the 13 core principles
Describe the roles and responsibilities of sponsors and investigators in conducting research
Evaluate informed consent and subject data management to ensure the protection of trial subjects and that data are credible, reliable, and accurate
Key Features Include:
High-level ICH GCP E6 R2 coverage
Focus on practical application of GCP principles and application-based activities
Glossary of terms, bookmarking tool, ongoing "knowledge checks" and post-course exam
Includes a Barnett certificate of training
Applicable for global clinical research professionals
Accreditation, Policies and Procedures