SD1251 - EXVAMTU is not null when EXTRTV is null

s Sophie

on July 20, 2020

Hi,

I do not understand this issue.

In the corresponding dataset, EXVAMTU is populated only both EXVAMT and EXTRT are filled in.

The error talks about EXTRTV, this variable was part of SDTM 3.1.3 and removed in SDTM 3.2.

Could you please clarify ? How can I explain this error in the csdrg ?

Forums: SDTM

Sergiy

on July 28, 2020

P21

SD1251 rule is based on official CDISC rule CG0108

Hi Sophie,

SD1251 rule is based on official CDISC rule CG0108 (EXVAMTU = null, when EXTRTV = null) for SDTM-IG 3.2. A CDISC source of this rule has a reference to SDTM Model rather than Implemention Guide.

EXTRTV, EXVAMT, EXVAMTU are standard variables only in SDTM-IG 3.1.3. However, --TRTV, --VAMT, --VAMTU variables are still in SDTM Models of all new versions. Therefore, these variables may be utilized in EX domain. In such case, SD1251 rule is applicable in all SDTM-IG versions starting 3.1.3.

I believe that a logic of SD1251 rule is very clear: "Treatment Vehicle Amount Units (--VAMTU) are applicable only if you provide Treatment Vehicle info (--TRTV)". I would extend a logic of this rule by additional requirement for non-missing value of Treatment Vehicle Amount. User may use Units only if both name of Trt vehicle and its administered amount are populated.

Kind Regards,

Sergiy