A web-based medical safety reporting system for a large multicenter clinical trial: the ALIAS experience.

ABSTRACT: An electronic safety reporting (ESR) module was developed and integrated into a home-grown web-based clinical trial management system (CTMS) to enhance the efficiency, completeness and consistency of reporting and reviewing serious adverse events, monitoring safety, and submitting safety reports to regulatory authorities for a large multicenter clinical trial. The architecture of this integrated module provided many advantages. First, the ESR module was developed based on a comprehensive procedure which incorporated both computer logic processing steps and human intervention steps in order to deal with the complex and unexpected situations where pre-programmed computer logic may fail. Second, safety and efficacy data were managed within the same relational database. Relevant data captured

SUBMITTER: Zhao W 

PROVIDER: S-EPMC2956856 | biostudies-literature | 2010 Nov

REPOSITORIES: biostudies-literature