AD0245-249 CNSR is present but XXX is not present. Where does it come from?

d Dmitry

on May 28, 2019

Hi,

I wanted to ask what is the source of rule AD0245 "CNSR is present but STARTDT" and similar rules 246-249? For example, for 245, in ADaM BDS for TTE specification STARTDT is marked as permissible. Other variables mentioned in 246-249 are also permissible. I could not find this rule in ADaM conformance rules (neither in version 1.2, nor in 2.0). Was there any clarification from the ADaM team or regulatory agencies regarding it? In ADaM conformance rules 2.0 a related rule 170 ("If STARTDT is present then CNSR must be present") is not present anymore.

Thank you.

Forums: ADaM

Trevor

on May 28, 2019

P21

Hi Dmitry, The rule you are…

Hi Dmitry,

The rule you are asking about is based on ADaM Validation Checks v1.3 (published 2015-03-17). Time-to-event related conformance rules (245 - 251) were removed from v2.0 of the rule set by CDISC ADaM team, but they are planning on bringing them back once Define-XML v2.1 is published. The reason for this is because there was no reliable way to determine if the ADaM dataset being checked was in fact a "time to event" dataset.

We (Pinnacle 21) decided to keep these rules for the time being because they will be re-introduced in a future release of the rules by CDISC ADaM team. We identify a dataset as being "time to event" based on the presence of a CNSR variable.

Thanks,
Trevor

d Dmitry

on May 28, 2019

Hi Trevor, Thank you for…

Hi Trevor,

Thank you for the clarification! My bad, I missed 1.3 on the CDISC site and that is where I needed to look to. It makes perfect sense to keep these rules.

By the way Define-XML 2.1 is already released, but it will definitely take some time before ADaM team releases a new version with these rules returned.