QC Assessment tool

Non Serious "a patient" cases, what are the classifications added in the case

Argus cases originating from "Switzerland:, if lab data with no results are mentioned only in the relevant tests ,then

Only "hospitalization" argus cases are

NN causality for "hyperglycaemia" is

Hospitalization dates mentioned in the narrative however missed to be populated in the tabs, is the case

All the medical history MedDRA coded in the tabs should be mentioned in the narrative

Partial DOB of the patient (e.g born in 1954) can be written in the narrative

Ongoing clinical trial cases, mismatch between medical history of DM complications such as retinopathy, ketoacidosis etc if there is discrepancy between the narrative and tabs. E.g Verbatim retinopathy MedDRA coded to diabetic retinopathy however narrative states as retinopathy

NN causality for AE "pregnancy" for clinical trial/solicited case is

It is ok to write the delivery date of the baby in narrative in pregnancy cases

For all drug exposure cases, reporter causality unknown in the tabs and

What should AE onset date be reported as for ‘drug exposure’ cases where the patient starts an NN product after pregnancy has been confirmed