Generation of xxSEQ

m Matthew

on October 5, 2011

Hi,

I am under the impression that result qualifiers, eg. LBORRES, CMDOSE cannot be used to generate xxSEQ, but I am unable to find this in the IG. Am I correct?

Thanks,
Matt

Update, managed to locate this in section 4.1.2.8.2. of the IG for result qualifiers (findings class), but have not come across anything for record qualifiers, e.g. CMDOSE (interventions class).

Forums: SDTM

s Sergiy

on November 28, 2011

Hi Matt, Could you provide

Hi Matt,

Could you provide any example when CMDOSE value is needed for CMSEQ value generation?

Thanks,

Sergiy

a Anthony

on December 10, 2011

Sponsors receiving external ECG data can relate to the example used in section 4.1.2.8.2 of SDTMIG: An ECG vendor has a record ID as part of record layout in each transfer. It is also possible to have more than 1 interpretation per test per subject per visit. In this case, as suggested in 4.1.2.8.2, such record ID may not be appropriate to be mapped to ECGSEQ, but "may elect to keep this variable in a Supplemental Qualifier record."

I would also imagine mapping the accession number to EGSPID.

HTH.