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  1. We can tell Stefan to use --CONC and --CONCU for exposure agent concentration and unit, and add them to the IS domain as NSVs, because IG3.2 and SDTM 2.0 still limit these variables to the MS domain only. Meanwhile, we work on getting these variables officially added to the other domains for IG4.0 or a later version of the IG (IS, CP, maybe GF too).
  2. Or we tell Stefan to pre-coordinate all that information into the Test Condition Agent (ISCNDAGT) variable.
  3. Other thoughts? Other ways forward?


Here is a mock example of Stefan's data using --CONC and --CONCU:

Dataset wrap
Dataset2
hi1styleyellow
hi1column ISBDAGNT
tableidIS table 1

Row

STUDYID

DOMAIN

USUBJID

SPDEVID

ISSEQ

ISTESTCD

ISTEST

ISTSTCND

ISCNDAGT

ISCONC

ISCONCU

ISORRES

ISORRESU

ISSTRESC

ISSTRESN

ISSTRESU

ISSPEC

ISMETHOD

ISDTC

1

ABC

IS

ABC-01-203

ABC001

1

IFNG

Interferon Gamma

WITHOUT STIMULATING AGENT


2.17

IU/mL

2.172.17

IU/mL

SERUM

ELISA/Other Method

2013-08-26

2

ABC

IS

ABC-01-203

ABC001

2

IFNG

Interferon Gamma

WITH STIMULATING AGENT

Study Drug

20

mg

6.2

IU/mL

6.26.2

IU/mL

SERUM

ELISA/Other Method

2013-08-26

3

ABC

IS

ABC-01-203

ABC001

3

IFNG

Interferon Gamma

WITH STIMULATING AGENT

Study Drug

40

mg

15.8

IU/mL

15.815.8

IU/mL

SERUM

ELISA/Other Method

2013-08-26
4ABCIS

ABC-01-203

ABC001

4

IFNG

Interferon Gamma

WITH STIMULATING AGENT

Other Test Agent

5

mg

3.33

IU/mL

3.333.33

IU/mL

SERUM

ELISA/Other Method

2013-08-26
5ABCIS

ABC-01-203

ABC001

5

IFNG

Interferon Gamma

WITH STIMULATING AGENT

Other Test Agent

15

mg

7.22

IU/mL

7.227.22

IU/mL

SERUM

ELISA/Other Method

2013-08-26