This topic was already discussed in the SEND Forum in 2015, but there is no change till today. SD0007 is still an error. It fires for the DA dataset, if subjects are dispensed both tablets and capsule at the same visit. In this case there are two records per visit with DATESTCD= DISPAMT, but DASTRESU is TABLET and CAPSULE. In a "double blind / double dummy trial" tablet and capsule can be both: study medication or placebo. Therefore a specification via DACAT is not possible. Concerning the trial design this is correct, but the dataset fails validation. There are other constellations, where this check fires erroneously (see discussion in SEND Forum). A downgrading from error to warning or info would be very helpful.
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This topic was already discussed in the SEND Forum in 2015, but there is no change till today. SD0007 is still an error. It fires for the DA dataset, if subjects are dispensed both tablets and capsule at the same visit. In this case there are two records per visit with DATESTCD= DISPAMT, but DASTRESU is TABLET and CAPSULE. In a "double blind / double dummy trial" tablet and capsule can be both: study medication or placebo. Therefore a specification via DACAT is not possible. Concerning the trial design this is correct, but the dataset fails validation. There are other constellations, where this check fires erroneously (see discussion in SEND Forum). A downgrading from error to warning or info would be very helpful.
Thanks.