SD0079: EX record present but subject is not assigned to an arm

m Martin

on July 6, 2010

I'm pretty confused about this. I'm using NOTASSGN as the arm code for subjects who enter run-in but are not randomized, as described in impl guide 3.1.2. However I've also put records in EX for these subjects because they are receiving study treatment during run-in (placebo in this case, but I know of other trials which have active non-randomized run-in periods).

I'm guessing this means I can't use NOTASSGN and have to invent a new arm code for these people, but it just seems wrong! Anybody know more about the background to this rule?

Thanks,

Martin

Forums: SDTM

m Max

on August 1, 2010

P21

Re: EX record present but subject is not assigned to an arm

Hi Martin,

You are correct in using NOTASSGN. If a subject is receiving placebo in the run-in, but never been assigned/randomized, then ARMCD should be NOTASSGN.

The presence of EX records will trigger SD0079, but it's just a Warning, not an Error.

Regards,
Max