Aspects of clinic monitoring in large‐scale multiclinic trials

Monitaring the implementation of large‐scale studies and the adherence of clinical centers to a common protocol should be an integral part of the study design and a primary responsibility of the coordinating center for the study. There are four basic concepts in external clinic monitoring: (1) the maintenance of open lines of communication between alt study facilities, (2) “responsibility and accountability” for study implementation and for the integrity of the data, (3) evaluation of clinic operations, and (4) analysis of data quality. A monitoring scheme consisting of regular telephone calts to the screening centers, periodic visits to the screening centers, and continuing review of the data coltected can be effectively used by the coordinating center.