What Could the Future of Safety Monitoring Look Like?
Ther Innov Regul Sci
; 53(5): 590-600, 2019 09.
Article
em En
| MEDLINE
| ID: mdl-31242748
ABSTRACT
Like much of the clinical research and health care provider enterprise, the data capture and archiving for harm, probability of harm, and impact of intervention-related events is fragmented, inconsistent, and lacks standards to perform the types of operations that could inform researchers, practitioners, and patients in a timely way of actions and policies. The entire system of assessments, terminology, data formats and structure, analyses, and dissemination would benefit from changes based on adherence to a process framework of detect, describe, analyze, and react in the context of recognizing the multiple pathways and factors that lead to any specific outcome or series of outcomes. Existing tools, if properly applied, can form the basis for the next generation of data systems, processes, analyses, and sharing to address most of the current challenges.
Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Coleta de Dados
/
Curadoria de Dados
Tipo de estudo:
Guideline
Limite:
Adolescent
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Adult
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Child
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Child, preschool
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Humans
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Infant
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Newborn
Idioma:
En
Ano de publicação:
2019
Tipo de documento:
Article