Data quality in a distributed data processing system: the SHEP Pilot Study.

The Systolic Hypertension in the Elderly Program (SHEP) Pilot was a collaborative clinical trial that distributed to the clinics all data processing tasks except for randomization assignment codes and morbidity and mortality data. The clinics used customized programs to enter and verify data interactively, to maintain their own local master files, and to transmit the data electronically to the Coordinating Center. We measured quality control based on criteria from centralized as well as distributed models: the error rate for baseline forms was 0.5 per 1000 items. Ninety-eight percent of the forms were query-free, and a central reentry of the data in a 5% sample yielded a miskey rate of 2 per 1000 items. The potential problems of distributed data processing are vulnerability of the local master files and the time demands on Coordinating Center programmers for maintaining clinic computer systems. The advantages are the active involvement of clinic staff in their own quality control, the functional accessibility of the clinics to the Coordinating Center in controlling protocol decisions and data monitoring, and the level of accuracy, completeness, and timeliness of the data that can be achieved.