ESDCAQ FAQ

Admit#10021see cardio Admit#10021see cardio Admit#10021see cardio
Zoya! There has been an SAE!!!
Calm down Tara.If there is an SAE, report it, and remember to mask PII before sending the documents.
I know Zoya!Raja has trained me on PII very well!
So then what's the concern?
You know, this hospital is so big! And each department has their rules. The subject got admitted with Cardiology department and they have their own EMR. Now I will have to complete one more ESDCAQ for that EMR right!!?
However, if patients are being hospitalized for protocol/study related procedures, then ESDCAQ assessment must be completed (Eg: hospitalisation for administrating study drug etc..)
Haahaahaa..No Tara.As a general rule, a separate ESDCAQ needs to be completed for each eSource system used by the site. Hence, your concern is valid.But, if the 2nd e-Source system is being used to record data generated during standard of care hospitalization (e.g. due to SAE) then ESDCAQ does not need to be completed.
Ohh..and what about the LIMS (Laboratory Information Management System) used by our local lab?
Supporting systems (e.g. Laboratory & imaging systems) are out of scope for ESDCAQ assessment.
Thanks Zoya!Phew! This is such a relief!

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