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 …
