System Integration of an Adverse Experience Thesaurus — Experience with a New Computer Methodology
| Autor: | Raymond L. Herman |
|---|---|
| Rok vydání: | 1986 |
| Předmět: |
Thesaurus (information retrieval)
business.industry Process (engineering) Public Health Environmental and Occupational Health Pharmacology (nursing) medicine.disease Unexpected events Drug Guides Controlled vocabulary medicine Mandate System integration Pharmacology (medical) Operations management Adverse Experience Business Adverse drug reaction |
| Zdroj: | Drug Information Journal. 20:351-355 |
| ISSN: | 0092-8615 |
| DOI: | 10.1177/009286158602000317 |
| Popis: | Federal regulations mandate that all drug-related adverse experiences that are reported to the pharmaceutical manufacturer be reported to the appropriate division of the Food & Drug Administration. The interval for reporting is specified in the regulations and depends upon the nature and severity of the specific adverse experience. The time requirement for severe or unexpected events is 15 working days. It is, therefore, in the best interest of the pharmaceutical company to establish a procedure by which this reporting process can be expedited. Accordingly, the Stuart Pharmaceuticals Drug Experience Reporting System was designed. The goals for this system are to provide an efficient and cost-effective method to record, evaluate, and report drug experiences, as well as to provide a timely response in accord with the FDA regulations. An important part of this system is a computer integrated controlled vocabulary sub-system which automatically reads the reported adverse experience terms and translates these ... |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|