Technical support questions about ADaM standard and validation rules

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

May 28, 2019


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.

Validation Error AD1011 - Secondary variable ANRHIC is populated but its primary variable ANRHI is not populated

May 22, 2019


When validating with the new Pinnacle 21 Community release we obtained the error below in the ADLB domain:

  • Secondary variable ANRHIC is populated but its primary variable ANRHI is not populated

We use these variables for out of range laboratory tables and these range variables are created from the SDTM variables LBSTNRHI and LBSTNRC. The records where the error flags may have ANRHIC=NEGATIVE/NOT DETECTED etc. and a numeric range would typically not be associated with these tests. 

Pinnacle21 v3.0.0 -> SD1230 (FDAB035) Value level datatype must match the datatype described in define.xml.

May 22, 2019


There is a new rule in the P21 v3.0.0 community version which requires a match of the VL datatype with the datatype described in define.xml. We have some missing values in AVAL (datatype described as integer) and we get a lot of errors because we have missing AVALs. AVAL is set to Mandatory = "No".  We did not have this issue before.

Pinnacle21 3.0.0 AD1012 - Secondary custom variable is present but its primary variable is not present

May 14, 2019


Im using the Pinnacle21 3.0.0 that covers ADaMIG v1.1 and I already have my first question:

why do I get the AD1012 message in each ADaM Domain regarding my variable “ADOMAIN”? The rule expects the variable “ADOMAI” in this case. We have other issues also where variables are ending with an “N”. 

Thanks in advance!



September 6, 2018

i have a question on treatment variables in adsl. lets say if some subjects are randomized to treatment A and others 

to control group. Later in the study the same control group subjects are given treatment A dose , So in  ADSL do we need to use trtseqx variables along with trtxp, trtxa or is there any better way. 




August 2, 2018


I received some ADaM datasets, and Pinnacle is throwing the AD0043 error in every dataset.  It turns out that the DTM variables were formatted as "IS8601DT."  I checked the TERMS attribute of the AD0043 rule, and I saw "E8601DT" is valid, which IS8601DT is an alias for.  Is this a false positive, and could the rule be extended to include aliases?

AD0053 USUBJID value does not exist in the SDTM DM domain

September 27, 2017

I goe this error message when i tried to validate ADaM datasets:

ID:              AD0053   

Message:    USUBJID value does not exist in the SDTM DM domain     

Description: Unique subject identifier not found in the SDTM Demographics domain. There must be traceability between ADaM and SDTM.


For the above error messsage, why it is generated? Or more general, how OpenCDISC check the traceability between ADaM and SDTM datasets?