Abstracts 707

We conclude that the SD = 2.5 screen requires approximately twice as much work as the SD = 3.0 screen for a gain of 17% in error detection.

P102 PROCESS OF OBTAINING NDI INFORMATION TO DETERMINE THE VITAL STATUS AND CAUSE OF

DEATH OF CASS REGISTRY PATIENTS

Grace Ng, Mary Jo GIIlesple, and Kathryn Davis University of Washington

Seattle, Washington

Identifying data on all CASS (Coronary Artery Surgery Study) registry patients, except for randomized cases and patients from Montreal Heart Institute, who are still believed to be alive are submitted to the NDI (National Death Index) for potential death information. For all deaths identified, NDI provides the names of the States where the deaths occurred, along with corresponding death certificate numbers and dates of death. Among the possible NDI matches, CASS is only interested in matches on social security number or personal data (exact match of first name, last name, sex, race and month, day and year of birth). In order to verify that the matches are true matches and to obtain the cause of death information, CASS then makes the necessary arrangements with appropdate state vital statistics offices to obtain death certificates. Each death certificate received is logged and visually checked against the CASS patient information to vedfy that the certificate is for a CASS patient. The matching death certificates are then sent to the nosologist for classifi- cation. When all the cause-ofdeath forms for a year's search have been entered, they are merged with the CASS main database, and the cycle is repeated.

P103 USE OF COMPUTER APPLICATIONS TO FACILITATE RETROACTIVE UPDATES TO A DATABASE

Rlta M. Peluelo, Charlyne Miller, Constance Orme, Mark L.Andrews, Cindy Casacell, Jenny Ueou, Karl Kleburtz, Jory Wlxsom, Ira ShouIson, and the Parklnson Study Group

DA TA TOP Coordination Center University of Rochester Rochester, New York

DATATOP (Deprenyl end Tocopherol Antioxidative Treatment of Parkinsonism) is a multicenter controlled clinical trial investigating new therapies for the treatment of early-stage Parkinson's disease. A highly suc- cessful recruitment campaign resulted in accelerated enrollment of subjects at all 28 study centers with concomitant acceleration of database development and management of the trial [1].

Rapid collection of an extremely large volume of data resulted in interim analysis early in the trial [2]. Routine monitoring of the database by the trial's Safety Monitoring Committee identified a need to extract greater detail surrounding data variables with the generic code designation of "other" in the adverse expe- riences data sets, for which test dascdption was not readily available in the electronic database. Prior to implementation of procedures for prospective review and coding of variables reported as =other," a plan was developed to update approximately 2,000 records in the database which were previously designated as =other." Manual and electronic methods were employed to facilitate review, correction, and updates to the data by means of a team approach including operations, programming, and clinical staff, and study site coordinators.

1. Pelusio, at al.: Controlled Clinical Trials (abstract) 11:304, 1990.

2. Parkinson Study Group: NEJM 321:1364-1371, 1989. (Supported by NS24778, NINDS, USPHS)

P104 IMPROVED MONITORING OF MULTICENTER TRIALS BY AN EXTENDED DATABASE

RoB Holle, Volker Welnbergef, and ChrlMIne Flecher University of Heidelberg Heidelberg, Germany

Dudng the conduct of multicentar clinical trials several monitoring tasks have to be performed by the statistics end data center, aiming at three different levels of information: intedm results about the study hypotheses, protocol adherence, end completeness and correctness of the data. The information concerning