Abstracts 95S

P34 USING AN IN-HOUSE CLINICAL RESEARCH DATABASE

TO AUTOMATICALLY GENERATE DATA IN ACES" OUTPUT FORMAT FOR THERADEX

Kai-Hsiung Lin ~, Katherine T. Fain ~, Rita KrishtuP, Jun Yan ~, Collette Houston ~, Daniel Wu n,

John Speakman l, Diana Vulih 2 and William G. Price 2, Jr. JMemorial Sloan-Kettering Cancer Center

New York, New York 2Theradex

New York, New York

The Clinical Research Database (CRDB) was developed in-house at Memorial Sloan- Kettering Cancer Center (MSKCC) as a repository for all clinical research data. However, when a Phase I/II contract is approved by the National Cancer Institute (NCI), the research data are also required to be entered into ACES'. ACES" is a program designed by Theradex, the current contractor providing NCI's Clinical Trials Monitoring Service (CTMS), to enable the entry of Case Report Forms (CRFs) in electronic format. ACES" then generates data files in a format readable by the existing Theradex computer system.

An initiative was established at MSKCC to improve data integrity and avoid duplication of data entry effort by enabling the CRDB to export data in the same structure and format as ACES'. This initiative involves: (1) establishing a standard CRDB process for interacting with external systems, (2) working to correlate data items and codes between the CRDB and Theradex, and (3) developing an algorithm to produce data manipulation information over a given time period from a multi-user real-time database.

The initiative was successful and the standard process, which has been in use at MSKCC for some time, is a systematic and flexible phased approach for exchanging data between the CRDB and foreign systems. The process is facilitated by a list of standard documentation requirements and a program that can store data code conversion definitions in the CRDB. The effort of mapping data elements and converting codes involves identifying and resolving data mismatched between the CRDB and ACES'. In producing the algorithm for generating ACES'compatible data files for Theradex, issues of generalization (the same algorithm and program is able to support new protocols without programming changes), error handling and recovery, reliability and performance were addressed.

P35 AN AUTOMATED MEDICAL EVENT TRACKING SYSTEM

Adam Payne, Scott Corley, Mary Mickel Statistics and Epidemiology Research Corporation

Seattle, Washington

The AFFIRM (Atrial Fibrillation Follow-up Investigation of Rhythm Management) Clinical Trial Center (CTC) has developed an automated system in Microsoft Access to track adverse medical events. Events are reported to the CTC on specific data forms. Supporting documentation is required, and this documentation varies based on the type of event. After all documentation for an event has been received the event must be blinded and reviewed by committees to assess cause and mechanism. Our system performs the following functions: (1) keeps track of incoming events, (2) maintains an inventory of medical records received pertaining to the event, (3) automatically generates letters to remind the Clinical Centers of medical records that are due for each event, (4) chooses an Events Committee member to review the event, and (5) tracks the status of the committee review. This system's graphical interface makes for easy Iracking of medical events. We will describe in detail the design and implementation of the automated system.