SMP- Quiz

Create an engaging illustration of a safety management meeting with diverse professionals discussing pharmacovigilance documents, featuring charts and documents in a modern office setting.

SMP Awareness Quiz

Welcome to the SMP Awareness Quiz! This quiz is designed to test your knowledge on safety management plans and pharmacovigilance processes. Whether you're a team member or just interested in the field, this quiz will help reinforce your understanding of key concepts.

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6 Questions2 MinutesCreated by AnalyzingData101

Who should ensure the PVL/ PV PM or designee is informed about any relevant project updates

Medical Monitor

Sponsor

Project Manager

It is not acceptable for the appendices to be updated as separate documents. It should be always update along with SMP

True

False

For projects where Caidya Pharmacovigilance is only contracted for safety submissions, which document is prepared instead of the SMP?

Safety Regulatory plan

Safety Reporting Plan

Safety Submission plan

In the event the SMP cannot be signed off by the Sponsor prior to FPFV, the SMP may be signed off by the…………., until Sponsor approval and signature can be obtained

Pharmacovigilance Project Manager

Safety Physician Pharmacovigilance

Caidya Chief Medical Officer

All of the above

Any changes to an appendix made in between full SMP version updates must be documented in the

SMP Edit Log

SMP Change Log

SMP Update Log

Version history

The SMP will be reviewed at least……...to ensure that all information is still up to date and complete

Bi-annually

Quarterly

Once per year

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