AD1001 and AD1005 in ADAE

Pinnacle 21 Support ADaM
1

Hi Heli,

OpenCDISC validation of ADaM standard is defined by the CDISC ADaM development team. See more details and the most recent “Version 1.2 of the ADaM Validation Checks” document on www.cdisc.org/adam in “Member Only” area.

Unfortunately those business rules are limited to ADSL and BDS data only. Therefore formally you should not use these configurations for validation of Analysis Adverse Events.

Plans for the future are still under discussions.

Kind Regards,

Sergiy

2

Hello,

Since the ADaM Data Structure for Adverse Event Analysis was released last May, there is no requirement for PARAM, PARAMCD and AVAL/AVALC to be present in ADAE. Is there any plan to prevent these errors from firing in ADAE or at least degrading them to warnings?

Thanks!