Vaccine Data Reporting: Standard,Yet Flexible

Abstract

The Biostatistics and Research Data Systems area of Merck Research Laboratories (MRL) has successfully addressed the dual needs of standardization and flexibility with the development of a powerful data reporting system for vaccine data. A generic automated reporting package for vaccines—Generic Table Package for Vaccines (GTV) — has been developed to provide medical and statistical users with the ability to screen and report vaccine data quickly and accurately. This package is immediately available to all new vaccines, without further programming, thus providing the user community with access to data summaries immediately after data entry. A Vaccine Standards Committee has been used to ensure that the system remains useful, complete, and stable, yet flexible. Data coding guidelines for tracking injections, injection components, and study progression have been developed to manage the intricacies of vaccine data. The success of the GTV1 programming effort can be attributed to three critical factors: 1. similar database design for all GTV1 compounds, 2. the development of, and compliance with, programming guidelines, and 3. parameter-driven software to provide the flexibility needed for data reporting. The keys to developing a standard reporting system in any pharmaceutical organization can be derived from the standards and procedures implemented in vaccine development at Merck.