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A typical database lock readiness criterion: Data review sign-offs obtained. Must be evidenced and documented before lock.
Applied during study conduct to improve quality and reduce delays: Lock Readiness Item: Data review sign-offs obtained.
Tracking Data review sign-offs obtained without defining thresholds or actions when the metric drifts.
How do you use "Lock Readiness Item: Data review sign-offs obtained" to make decisions and document your actions?