Coordinating data management for multiple ongoing clinical trials and registries

Top Health Rec Manage. 1990 Dec;11(2):13-9.

Abstract

The Epidemiology Data Center at the University of Pittsburgh has developed a standard set of data management procedures, reports, and computing configurations for use on multicenter research projects. Based on budget restrictions and study design considerations, a project-specific data management system can be quickly constructed by utilizing appropriate components from the EDC tool kit: the PoP software system for the computerization of the database from paper forms to data entry screens; program shells for telecommunication and backup procedures; and procedural documents for providing the necessary training materials for centralized or decentralized processing environments. The EDC data flow specification provides quality control assurances from entry through statistical analysis.

MeSH terms

  • Clinical Trials as Topic*
  • Database Management Systems*
  • Epidemiology / organization & administration
  • Pennsylvania
  • Registries*
  • United States