Patient Adverse Event Reporting Process

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CreativeOrientalism
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Questions and Answers

What type of information is included in Safety Information?

All of the above and more

What should the agent do as soon as an Adverse Event is identified?

Fill the Novo Nordisk AE/PC reporting form

What is the purpose of the Novo Nordisk AE/PC reporting form?

To collect as much information as possible about the Adverse Event

What type of exposure should be reported according to the Safety Information?

<p>All of the above and breastfeeding exposure</p> Signup and view all the answers

What should be reported in relation to pregnancies?

<p>All reports relating to pregnancies, including the outcome</p> Signup and view all the answers

What is an example of a Serious outcome?

<p>Hospitalization</p> Signup and view all the answers

What should be reported in relation to Medical Devices?

<p>All device failures, even if no harm occurred</p> Signup and view all the answers

What type of use should be reported according to the Safety Information?

<p>Only off-label use</p> Signup and view all the answers

What is the agent's responsibility in terms of collecting information about the Adverse Event?

<p>To collect as much information as possible</p> Signup and view all the answers

What is included in the category of Adverse Events?

<p>All reports of Adverse Events, including overdose and drug abuse</p> Signup and view all the answers

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