Special Feature of MH Domain

カテゴリー: CDISCラボ

First of all, please see the following.

20150817xa.gif

Then, please compare against the following.

20150817xb.gif

Here, we clearly see the special feature of --REASND variable in MH domain. In general, --REASND variable stores the detailed reason why the observation is not done. In MH domain, the variable also holds the reason not OCCURED. When we see change log, it tells us that this is updated part for SDTM version 1.4 (SDTM IG 3.2).

This looks trikky a bit. However, it may be suitable for MH domain. MH domain sometimes holds the record of past treatments whenever this handling looks better. In this scenario, we see different kind of reason NOT DONE.

1. Reason why the investigation is NOT DONE.
Investigator forgot to ask (or cannot ask) if the treatments had been taken. In this case, possible values are "Subject left the site before planned procedures are completed", "Subject refused to answer". SDTM dataset looks like this.

 MHSTAT=NOT DONE
 MHREASND="..."

2. Reason why the treatment is NOT DONE.
Investigator clarified that pre-specified treatments had not been taken. Thus, the question itself was performed. Subject may give the reason why. In this case, SDTM dataset looks as follows

 MHTERM="..."
 MHPRESP=Y
 MHOCCUR=N
 MHREASND="Subject didn't agreed"

This may not be practical for your daily work. CDISC is a living standard and another approach may replace this method (We prefer the other idea and you may have several ideas to implement this scenario). It's just a small tips of SDTM specification.
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