...
- 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).
- Or we tell Stefan to pre-coordinate all that information into the Test Condition Agent (ISCNDAGT) variable.
- Other thoughts? Other ways forward?
Here is a mock example of Stefan's data using --CONC and --CONCU:
Dataset wrap |
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Dataset2 |
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hi1style | yellow |
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hi1 | column ISBDAGNT |
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tableid | IS table 1 |
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| Row | STUDYID | DOMAIN | USUBJID | SPDEVID | ISSEQ | ISTESTCD | ISTEST | ISTSTCND | ISCNDAGT | ISCONC | ISCONCU | ISORRES | ISORRESU | ISSTRESC | ISSTRESN | ISSTRESU | ISSPEC | ISMETHOD | ISDTC |
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1 | ABC | IS | ABC-01-203 | ABC001 | 1 | IFNG | Interferon Gamma | WITHOUT STIMULATING AGENT |
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| 2.17 | IU/mL | 2.17 | 2.17 | 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 | 6.2 | 6.2 | 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 | 15.8 | 15.8 | IU/mL | SERUM | ELISA/Other Method | 2013-08-26 | 4 | ABC | IS | ABC-01-203 | ABC001 | 4 | IFNG | Interferon Gamma | WITH STIMULATING AGENT | Other Test Agent | 5 | mg | 3.33 | IU/mL | 3.33 | 3.33 | IU/mL | SERUM | ELISA/Other Method | 2013-08-26 | 5 | ABC | IS | ABC-01-203 | ABC001 | 5 | IFNG | Interferon Gamma | WITH STIMULATING AGENT | Other Test Agent | 15 | mg | 7.22 | IU/mL | 7.22 | 7.22 | IU/mL | SERUM | ELISA/Other Method | 2013-08-26 |
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