Clinical Research and GCP Update

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How E8(R1) will affect trial conduct and influence changes to E6

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E8 key aspects linking to E6

• Principles • Quality • Quality by design • Designing quality into clinical trials • Critical to Quality Factors • Risk proportionate approach • Involvement of wide range of stakeholders in clinical trial design • Examples of critical to quality factors

Note terminology difference E8 – clinical “studies” - was “trials” in previous 1997 version. E6 – always clinical “trials”

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