2018-10 Webinar What ICH E6 R2 Really Means for Research Sites Portfolio2

What ICH E6 R2 Really Means for Research Sites!

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Presented by:  Mary McGuire, R.N., Clinical QA Consultant at Polaris Compliance Consultants You’ve heard it before — the revision to ICH E6 [ICH E6(E2)] includes many new elements; an emphasis on, and revision to, ALCOA principles for study data, validation expectations for computer systems, risk-based trial management, and additional PI oversight responsibilities. What does this all mean, as a practical matter, for …