PVL-PVSOP-008 does not cover the processing of what type of ICSRs?

• ICSRs from interventional Clinical Trials

• Safety information from Internet

• Special Situation reports from Unsolicited sources

• Cases downloaded from Regulatory Agencies

Suspected transmission via a  medicinal product of  an infectious agent is always considered _______?

• Non serious

• Serious

• Depends on the information

Angela took an Aspirin and developed a rash on her hands. She decided to stop taking the medication and the rash resolved. Determine dechallenge.

• Positive

• Negative

• Unknown

• Not applicable

How many reporters can be marked as primary reporter?

• 0

• 1

• 2

• 3

Which symbol is used as a wild card in Argus?

• %

• _

• /

• *

MedWatch is a form used by...?

• EMA

• FDA

• MHRA

• PMDA

Follow-up information in a blended narrative is added between?

• **

• __

• %%

• !!

When can a blind be broken?

• At any point during case processing

• After QC when the Processor determines that the case qualifies for a SUSAR

• After MR after the Physician confirms that the case qualifies for a SUSAR

• After the Project Manager gets approval from the Director

How many priorities exist in Argus?

• 5

• 6

• 7

• 8

EMA requiers reporting of non-serious domestic cases within how many days?

• 15

• 20

• 30

• 90