New Starter PV Quiz 2

In Clinical Trials, all source documents (e.g. SAE forms) need to be verified and signed by:

• Project Manager

• Investigator of sub-investgator

• ICSR Team Lead

• PV Associate

What is the code of the document titled: Data Entry Guidelines for Argus?

• PVL-PVSOP-008

• PVL-PVOG-060

• PVL-PVOG-058

• PVL-PVSOP-028

The client received the report from a consumer on 05-Mar-2023. This report was forwarded to PrimeVigilance on 09-Mar-2023. The Administrator sent this case to Triage on the 10-Mar-2023. Determine day zero.

• 05-Mar

• 09-Mar

• 10-Mar

If the causal relationship is not reported, all spontaneous reports will be considered as related by the primary source – this is also known as _______ causality.

• general

• implied

• possible

• severe

How many priorities exist in Argus?

• 5

• 6

• 7

• 8

How many follow-up attempts should be attempted for the Serious Unexpected cases?

• 1

• 2

• 3

• 0

Suspected transmission of an infectious agent via a medicinal product should always be considered as unlisted/unexpected.

• True

• False

From 31-Jan-2022, all SUSARs occurring in the clinical trials authorized under Clinical Trials Directive or Clinical Trials Regulation should be submitted directly to ______ only.

• EVCTM

• EMCVT

• FDA

• SPONCT

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

• 15

• 30

• 90

• 10