pharmaverse / sdtmchecks

Analysis facing checks for SDTM data
https://pharmaverse.github.io/sdtmchecks/
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check_ae_aeacn_ds_disctx_covid - check NA #330

Closed sarabodach closed 1 month ago

sarabodach commented 1 month ago

A few details about this check: 1) This is one of only a few data check functions that requires DSSPID so that the string "DISCTX" can be identified (to distinguish the form as a Treatment Discontinuation form rather than a Subject Disposition form from DS). With the DSCAT values overlapping for these two forms, the DSSCAT variable often has the treatment name, but the specific drug name (e.g., "MOLECULE ABC") is used and rather than a more generic term. 2) It searches for the explicit string of DSDECOD = 'ADVERSE EVENT'. A participant may have a COVID-19 AE with AE action of DRUG WITHDRAWN -and- a DISCTX form that indicates discontinuation, but if DSDECOD is not 'ADVERSE EVENT', the record will be flagged. This detail was not clear and has been added to the roxygen2 title. (To check: Is this older SDTM mapping, or is it still relevant to newer studies on newer SDTM models? Though this may be OK as is because this check is mostly used for in-progress, long-term studies that were conducted during the COVID-19 pandemic.) 3) There is a scenario when a participant may take multiple drugs, and AEACN1 = "DRUG WITHDRAWN" and AEACN2 = "DRUG WITHDRAWN". If there is a single DISCTX record indicating DSDECOD = 'ADVERSE EVENT', this yields a pass, which may be a false negative depending on data collection.