SD1340 & SD2237, EX records while using ACTARMUD

z Zhu

on October 21, 2021

Hello,

I am now working on a study where subjects were randomized to use drug A or drug B.

One subject was randomized to drug A group but mistakenly took drug B. So, for this subject, ARM='DRUG A'. Problems came when give value to ACTARM. If I let ACTARM='DRUG B', I would get warning SD2237 ('ACTARM does not equal ARM'). However, if I left ACTARM as null and let ACTARMUD(Description of Unplanned Actual Arm)='DRUG B', since there were exposure records of this subject in EX domain, I would get another warning SD1340 ('EX record is present, when subject is not treated'), whose discription was 'Subjects that are not treated (ACTARMCD='NOTTRT' or null) should not have any Exposure records. Run-in records (EPOCH='RUN-IN') are excluded from firing for this validation rule.'

Should SD1340 rule take ACTARMUD into consideration?

Thanks,

Lijie

Forums: SDTM

Sergiy

on October 21, 2021

P21

Hi Lijie, In your case…

Hi Lijie,

In your case ACTARM='DRUG B'.

It's OK! to have SD2237 validation message. Its purpose is to ensure that you have documented and explain your study protocol compliance issue for reviewers.

A missing value in ACTARM means that subject did not receive any study drug.

Kind Regards,
Sergiy

z Zhu

on October 28, 2021

Hi Sergiy,Thanks for your…

Hi Sergiy,

Thanks for your helpful reply, but l still have some questions about 'ACTARMUD'.

According to SDTM IG V3.3, this variable is used to describe unplaned actual arm.

In my cases, it is also possible that a subject took both study drugs while he/she should only take one, and this combination treatment was not described in any planned trial arms (not included in TA). But since the treatment contained study drug (had exposure records) , should I define ACTARM by the discription of the combination treatment?

If so, in which situations should we use the variable 'ACTARMUD'?

Thanks.

Best,

Lijie