CMP & Documentation

Central Monitoring Plan

Typically, Central Monitoring details for a given study are documented in the study-specific Central Monitoring Plan (CMP) including analyses to be used, frequency of review, and other pertinent details.

Documenting CM Review

Typically, CM processes should include documentation of all the signals surfaced by analytics tools, the decision to action a signal or not (with rationale), and documentation of the review cycle (to align with the study-specific CMP).