MCC Members Decide to Utilize the MHRA’s Definition of Critical & Major Findings as the Reference Model for MCC Metrics

Wednesday, July 16, 2014

MCC will adopt the MHRA’s Definition of Critical & Major Findings as the reference model for MCC metrics. Overall, the MHRA’s definition has greater specificity and the “critical” findings definition include important areas not cited in other regulatory authority definitions (i.e. TMF not available or incomplete; inappropriate, insufficient or untimely corrective action of previously reported Major non-compliances).