Reporting and Tracking Spontaneous Adverse Experience Reports via a Computer Database
@article{Hostelley1989ReportingAT,
title={Reporting and Tracking Spontaneous Adverse Experience Reports via a Computer Database},
author={Linda S. Hostelley},
journal={Therapeutic Innovation \& Regulatory Science},
year={1989},
volume={23},
pages={171 - 177}
}Creation of a computerized document tracking system utilizing a FOCUS software package provides the user with a means of verifying the receipt and transmission of safety information within and outside of the immediate product safety department. In addition, this computerized document tracking system, coupled with a spontaneous adverse experience database system, provides management with the capability of monitoring adverse experience information and its processing.
3 Citations
Adverse Event Database Construction and Use: I. Software Design
- Computer Science
- 1993
Key elements of database software design are described to facilitate data entry and report generation, and to increase flexibility in adapting to changing needs and overall dependability of the systems used to capture, track, and/or report adverse event information.
Implementation of a Worldwide Drug Safety Surveillance System
- Medicine
- 1990
A worldwide adverse drug event monitoring and management system is described and surveillance methods are described, coordination problems are outlined, and sources of bias in assessing incidence changes are discussed.
Evaluation of Drug Adverse Event Intake and Reporting in a Medical Information Service
- Medicine
- 2011
Through this research, a benchmark for evaluating AE data quality and data collection in a pharmaceutical industry-based medical information service (PIMIS) is created.
One Reference
Multiple Suspect Drug Report Product A Manufacturer Date File Product control sent to Receipt number Section code number the FDA date 870099 1 Β
- 1985