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Froggy Jumps
Froggy Jumps

Gestion de eventos adversos

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Gestion de eventos adversos

Froggy Jumps

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About this activity

POE gestion de eventos adverso PR-GIN-026

Created by

Olga Lucia Acosta U.
Olga Lucia Acosta U.
Colombia

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Gestion de eventos adversos
 

Froggy Jumps

Gestion de eventos adversosOnline version

POE gestion de eventos adverso PR-GIN-026

by Olga Lucia Acosta U.
1

¿El objetivo del POE gestion de eventos adversos es?

2

¿Quienes es el responsable de la gestion de los eventos adversos?

3

¿Evento adverso de interes especial es?

4

SUSAR es?

5

Todo el personal que trabaje en CAIMED debe estar entrenado en el reporte de un evento adverso debido a que esta información puede ser recibida por cualquier colaborador.

6

reportar al patrocinador del estudio/CRO a las 72 horas después de conocido el evento y Comité de Ética de acuerdo a los tiempos definidos por la regulación local.

7

Los reportes de eventos adversos podrán ser identificados desde que el sujeto complete la firma del informe de consentimiento informado hasta la visita de finalización del sujeto participante o de acuerdo a lo que el protocolo establezca.

8

Para verificar la seriedad del evento (serio o no serio) el auxiliar de investigacion intentará un nuevo contacto telefónico para obtener detalles del evento después de que el Coordinador de Estudio le ha informado que se trata de un potencial SAE

9

Se deberá registrar en el documento fuente (historia clínica) toda la información pertinente que incluya fecha de inicio, de finalización, análisis de causalidad, manejo requerido y seriedad.

10

En el caso de Colombia, la participación del Químico Farmacéutico (QF) en la relación causal de los eventos serios será necesaria cuando:

 
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