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QC Assessment tool -QUIZ 2

If outcome has been reported as 'stabilised", what should be enetered in Argus

Not reported

Not recovered

Stabilised

Unknown

If the suspect product is liraglutide (unknown brand), listedness is based on

Victoza CCDS

AE should be listed in either Victoza OR saxenda CCDS

Saxenda CCDS

AE should be listed in both Victoza AND saxenda CCDS

Which feild triggeers a additional action of informaing the QA about the error

Patient privacy data in narrative

Incorrect AE onset date

Discrepancy within the narartive

Incorrect suspect product start date in narrative

Recently we came across a scenario where all the AE from this trial should be kept unlisted (also a mail from safety survelliance confirmed this)

NN 304-4018

Pioneer

NN7088-3908 trial/product N8-GP

All of the above

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