MHENDTC mapping

Pinnacle 21 Support SDTM
1

Hi Olga,

In general, it depends on intended/planned use of Med History in your study. How are you going to analyze these data?

In most cases MH is used for I/E screening and as one of covariates for balancing in randomization. Then utilization of MEENDTC variable looks fine. It may be not important for analysis at all.

Some users collect Medical History as one of study focused events. For example, history and ongoing seasonal allergies in study of treatment for hay fever. These ongoing signs and symptoms may be better represented as Clinical Events rather than Medical History.

Kind Regards,
Sergiy

2

Hi Sergiy,

Thank you for your response and detailed example. Makes sense.

3

Hi CDISC Experts!
I apologize if this question has been asked before.
If subject enters study with ongoing Med History, takes study drug and after a couple of months Med History event ends.
Do we map end of Med History event to MH.MHENDTC even though MH is collected only during Screening? Or there is another place where we can map end of, for example, seasonal allergies after subject started taking study drug.
Thank you for taking your time!