P06 Automated edit system from data entry to site notification

Abstracts database. Monitoring for completeness has become primarily the research nurse’s responsibility and with the loss of vidual cues, e.g., paper forms, to help identify missing items, this task has become a management issue. In solving this problem, the research nurses have had to develop more involved bookkeeping systems to compensate for the absence of paper forms. Software have been developed to identify incomplete data items at the local level. More frequent and detailed reporting by the coordinating center of the forms received and outstanding prevents omission of entire forms. Centralized reporting of missing data items is also necessary periodically. Future IDMS software could improve completion rates via internal systems for tracking incomplete or missing forms and missing data items and by requiring completion as a criterion for inclusion into the main database.

AUTOMATED

PO6 EDIT SYSTEM FROM DATA ENTRY TO SITE NOTIFICATION Merrie Jean Harrison and Alam Gene DuChene University of Minnesota

Minneapoliv, Minnesota In clinical trials, a large amount of effort is spent on the data editing process. It can be frustrating and time consuming for both clinical site and coordinating center staff, as they struggle to understand just what needs correcting, and the best way to communicate that information. The edit system of the CPCRA has evolved into a database driven, computer generated system that includes the actual edit program, and the detailed edit report of data items that need to be verified or corrected. The edits can be very complex, using linked data within the edited form and across pertinent databases. The edit report is a detailed and very specific documentation of each error condition found by the edit program, and is formatted as a memo, ready to fax directly to clinical site staff who are responsible for making corrections to the source case report forms.

A COMPLETELY

AUTOMATED

PO7 INTERACTIVE

DATA MANAGEMENT

SYSTEM

Raslan Othman and Jerome Sacks

VA Medical Center Hines, Illinois The interactive data management system (IDM) has been operational for over a year in 2 multi-center studies of the Department of Veterans Affairs Cooperative Studies Program. Initially the system automated data collection, editing and database management. Automation has now been extended to include menu driven utilities and automated modem connection with the study coordinating center for data transmission and for remote help with the study systems analyst. The main menu lists four basic system components: Data Forms (data collection, data editing), Utilities (missing forms lists, follow-up schedules, etc.), Data Transmission and Remote Help. The user selects “Data Forms” for a menu of data forms or Wtilities” for a menu of the study utilities. The “Data Transmission” option dials the computer at the study coordinating center and transmits the current cumulative database. The user must enter a password for validation and to establish connection. The current database is automatically transmitted for incorporation into the master database. The connection is automatically ended when the database has been transmitted. The “Remote Help” option connects the user to the