Course Title |
Introduction to GCP |
Course Format |
One or two day classroom course with a combination of presentations and workshop sessions |
Learning Objectives |
By the end of this course participants will be able to:
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Who is it for? |
This course is aimed at those new to clinical research. The content can be tailored to the function of the audience, for example, CRAs, CTAs, support staff, staff from service providers. |
Course Content |
Background and history to Clinical Trials legislation
ICH GCP (R2)
FDA 21CFR
EU Legislation governing clinical research
UK Statutory Instruments (optional)
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Enquire About This Course |
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Clinical Trial Designs Interpreting Results in Medical Literature Introduction to Clinical Research Sample Sizing for Clinical Researchers Statistical Considerations for Trial Design Statistics for Non-Statisticians Understanding Data Management In Clinical Trials |
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GCP Update Introduction to GCP Sponsor Responsibilities for Clinical Trials |