Non-BDS, non-ADSL dataset validation

j Joan

on September 7, 2011

Right now the validator won't process datasets that are "instance" type, such as ADAE, ADCM, etc. because it won't recognize them without key variables such as PARAMCD, PARAM, etc. How would we set up a section to recognize the other kind of datasets to run off of a list of the rules (could turn off some of the rules relating to parameter analysis with the attribute setting of Active="No").

Will the validator 1.3 also be generalized to admit datasets that aren't BDS or ADSL?

Thanks very much.

- Joan

Forums: ADaM

m Michael

on September 7, 2011

BDS

True, the ADaM IG 1.0 and Standard 2.1 indicated that The BDS was not designed to support analysis of incidence of adverse events or other occurrence data..and that ADAE is a future standard. The ADaM team is currently working on a specification document for an ADAE dataset supporting analysis of incidence of adverse events. ADAE may be the first example of a more general structure supporting analysis of incidence data, such as adverse events, concomitant medications, etc.

Therefore OpenCDISC does not support it at this time.

As for BDS, it must be named using the convention “ADxxxxxx”. PARAMCD and PARAM are required to be present with all BDS datasets.

OpenCDISC will validate the other Datasets once we have the structure and rules published by the ADaM team.

j Joan

on September 7, 2011

BDS, ADAE

Then I guess we are not able to apply any of the global (non-parameter) rules to the draft ADAE model (Draft 1.0) that CDISC team posted from Feb. 2 as pdf. That's too bad - I would be anxious to do some of the checks, such as correspondence of ----GRy to -----GRyN and similar basic consistency checks. We have been using the draft model as our starting point, since BDS of course is not a fit for adverse events. Thanks for the information and your help!

Regards,

Joan

m Michael

on September 8, 2011

ADD PARAMCD ?

As a temporary solution, can you simply add PARAMCD to your ADAE and ADCM files so that OpenCDISC recognizes them as BDS and therefore runs the BDS checks against them ?