Rule SD0021 and SD0031, Validated data for MH.xpt

I think if you specify a

I think if you specify a medical history condition and don't specifiy that it didn't occur (MHOCCUR=N), then we assume it did occur and therefore it must have either ...

a start and end date (MHSTDTC and MHENDTC)

or

start and end reference to study reference date (DM.RFSTDTC)

Basically, if some medical history condition occured, we want to ensure the timing relative to the study.

Many thanks for your

Many thanks for your comments.

I think it is better if I can define the start and end reference to study reference date,

But I could not define "MHSTRF" since there is no "MHSTRF" variable in SDTM IG.

Clarification on MH domain and rule

If a medical condition occured, then you must have one of these pairs:

a start date (MHSTDTC) and end date (MHENDTC)

or

start relative to reference period (MHSTRF) and end relative to reference period  (MHENRF).  

The sponsor defined reference period = DM.RFSTDTC and DM.RFENDTC

Recall that the SDTM IG only EXPLICITY lists the most commonly used or recommend variables for each domain.  Below each DOMAIN section are assumptions.   The assumptions list which other variables SHOULD NOT be used and other variables which MAY be used.   in cases where they neither explicity include or exclude a variable, then OpenCDISC assumes that variable is valid.

The punch line here is p 113 #5b (Timing Variables) of the section 6.2.3.1 ASSUMPTIONS FOR MEDICAL HISTORY DOMAIN MODEL.  It states:

"Additional timing variables (such as MHSTRF) may be used when appropriate."

Mike DiGiantomasso

OpenCDISC