Abstracts 93s

PO4 CONSISTENCY CHECKS IN A MULTI-CENTERED CLINICAL STUDY

Victoria Konig, Susan Sunkle and Lori Schnur for the Pediatric Pulmonary and Cardiovascular Complications

of Vertically Transmitted HIV Infection (p’c’ HIV) Study Group National Heart, Lung and Blood lnstihrte

The Cleveland Clinic Foundiatian Cleveland, Ohio

The P’C’ HIV Study is an NHLBI-sponsored multi-center study collecting data via a PC-based distributed data entry system. Data quality control is partly maintained through an off-line consistency check system. Inconsistencies identified by the Data Coordinating Center (DCC) through the system are entered into a query database. A query is generated and sent to the appropriate Clinical Center (CC) via e-mail. The CC reviews the query and edits the data inconsistency. An e-mail response is sent to the DCC documenting the correction and requesting closure of the query. Resolving data inconsistencies can be time-consuming for individuals at both the DCC and the CC.

In the fall of 1994, the system was reassessed. A majority of the routine checks were transferred to the CC. The CC now generates the consistency check report on a monthly basis. Inconsistencies are reviewed and corrected at the CC without DCC involvement. The DCC monitors the use of the system periodically to insure the proper use of the utility. By allowing the CC to perform consistency checks, the process of resolving routine inconsistencies is streamlined, leaving the DCC out of the loop.

The transfer of responsibility for routine data checks resulted in: (1) decrease in the number of queries sent by the DCC (510 [34%] of 1,492 queries in 1994, would have been prevented with thii new system); (2) empowerment of CC personnel in a proactive data quality control process; and (3) less time required by the DCC and CC for resolution of routine inconsistencies.

PO5 ADAPTING MANAGEMENT TECHNIQUES AFTER CONVERSION

TO AN ONSITE, INTERACTIVE DATA MANAGEMENT SYSTEM (IDMS)

Nancy Ellis, Thomas Moritx and William Henderson Center for Cooperative Studies in Health Services

VA Medical Center Hines, Illinois

In VA CSHS Study #5, “Processes, Structures, and Outcomes of Care in Cardiac Surgery” approximately 1400 variables are being collected on 6000 patients in order to study every aspect of care at the time of cardiac surgery. The IDMS was developed to facilitate collection and management of this large database. With the IDMS data are entered locally and edited interactively on laptop computers by the research nurses and transmitted biweekly to the coordinating center. Although the IDMS has simplified many aspects of data coB&ion and drastically reduced the time from data coHectiion to inclusion in the main database unexpected problems have occurred. With the paper form system the coordinating center monitored each form for completeness. Incomplete or incorrectly completed forms were held up until all data items were completed and corrections were made. With the IDMS, inconsistent or out of range data are corrected at entry and data are added to the database on transmission from the individual sites. However, there is no requirement for completeness of data for inclusion in the main

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.

PO6 AUTOMATED 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.

PO7 A COMPLETELY AUTOMATED 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