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?
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