SD1339 incorrectly firing in DV

t Thierry

on February 6, 2020

Hi,

We got SD1339, "Missing EPOCH value, when a start or observation date is provided", firing in a DV domain where DVDTC is populated (date when the deviation was reported), but DVSTDTC/DVENDTC are missing (dates when the deviation occurred). Per SDTM-IG, EPOCH in DV is the "Epoch associated with the start date/time of the deviation". It should therefore not be tested against DVDTC.

Kind regards,
-- Thierry

Forums: SDTM

Sergiy

on February 6, 2020

P21

Hi Thierry, Thank you for…

Hi Thierry,

Thank you for reporting this bug!

Kind Regards,

Sergiy

s Sandra

on August 24, 2022

EPOCH in Events & Interventions Domains

Sergiy,

Was this fixed only for DV domain? Guidance was added in SDTMIG 3.3 to clarify that "When EPOCH is included in a Findings class domain, it should be based on the --DTC variable, since this is the date/time of the test or, for tests performed on specimens, the date/time of specimen collection. For observations in Interventions or Events class domains, EPOCH should be based on the --STDTC variable, since this is the start of the Intervention or Event." We are getting issues for SD1339 when a start date (STDTC) is null for an Event or Intervention record but collection date (DTC) is available, however collection date may not be reliable to appropriately assign EPOCH.

Thank you,

Sandy

Sergiy

on August 25, 2022

P21

Hi Sandy, SD1339 rule is…

Hi Sandy,

SD1339 rule is designed for/by reviewers.

Now we plan to tune SD1339 rule. Here are some upcoming enhancements:

Split the rule for Findings and Intervention/Events where --DTC variable is not applicable.
Exclude records where *DY < 0
Add RFICDTC variable in algorithm to exclude records before subject informed consent

Kind Regards,
Sergiy