AD0083 and AD0084, TRTSDT and TRTEDT comparison with periods of treatment

j Joan

on November 19, 2014

Hi,

Some studies include start or end elements with No Treatment, and the treatment starts after the first period, or it ends before the last period, at least for some Arms in the study. So TR01SDT value may be null for some subjects, or max period TRxxEDT column value may be null for some subjects.

Should the AD0083 check be compared against the date in the earliest period TRxxSDT with nonnull value for the date, instead of always against TR01SDT which may be null? Similar question for AD0084, should the comparison be against the max period that has non-null date in the record?

Otherwise, the flags may be false positives.

Thanks,

Joan

Forums: ADaM

m Michael

on December 2, 2014

AD0083

I understand your above point about this rule below

Patient's Overall Treatment Start Date does not equal the first treatment in Period 01. If TR01SDT (first treatment in Period 01) exists.. it must equal TRTSDT (First Treatment Date of entire trial for a given patient)

But for now we are simply implementing the published CDISC ADaM Validation rules. For change in authoring, we can certainly consider it. However the team that may want to formally address the requirement is the CDISC ADaM Validation Subteam lead by Shelley Dunn