A Clinical Database Management System

The processing of Case Report Form data collected in clinical trials is a data processing task unlike any other. Conventional systems approaches to clinical data management are not responsive to user demands and require excessive amounts of manpower to support. The Clinical Data Management System implemented at Merck utilizes Infodata's INQUIRE database management software, IBM's CICS communications software, IBM's VSAM file management software, and SAS Institute's SAS software. System flexibility was the paramount consideration when the CDMS was designed. Clinical data at Merck is now processed on a system that provides on-line ad hoc retrieval capabilities through a user friendly query language, and allows for drug specific database designs coupled with a common update and retrieval mechanism.