Details
-
Change Request
-
Resolution: Persuasive
-
Medium
-
CDISC Mappings (FHIR)
-
1.0.0
-
Biomedical Research & Regulation
-
Adverse Events
-
-
Rik Smithies /Smita Hastak: 12-0-2
-
Correction
-
Non-compatible
-
1.0.0
Description
For the AE SDTM AETERM, the FHIR resource should have been AdverseEvent.event.CodeableConcept or if we look towards R5, it should be AdverseEvent.code.CodeableConcept
Others with the same error for FHIRPath include: AEDECOD, AELLT, AELLTCD, AEPTCD, AEHLT, AEHLTCD, AEHLGT, AEHLGTCD, AESOC, AESOCCD,
The FHIRPath column is incorrect.
Please check also the Element column for these variables. Should these be "AdverseEvent.event" or "Condition"; and what is the difference between these? Seems like the adverse event list is a valueset of the conditions that may be adverse events. Is this right?
Thank you.