Technical support questions about ADaM standard and validation rules

AD9999 : Dataset SV not Validated

August 9, 2019

Hi there,

PVAL v3.0.1 is trigerring  "Dataset SV not validated" Error  for ADaM data validation. The sdtm datasets AE and SV has been used to check for any cross referencing issues.

Can you help us to identify the root cause for this error? I see that v2.2.0 of pval triggers this as 'Warning' as supposed to 'Error' in 3.0.1.

The config file used is ADaM-IG1.0(FDA).xml


July 24, 2019

Hi all,

Could you please say the difference between ADRS and ADORS. I have understood that ADRS derived parameters are calculated from ADTR. On the other hand ADORS has just evaluations of investigators and parameters are predecessors from RS, aren't they?

AD0033 - AD0036

July 10, 2019


I have created variable name ended with *PFL and *RFN in my BDS dataset and having values except "Y" and '1'.

But I am not getting error/warning in pinnacle validator related to rules from AD0033 - AD0036.

Whether these issues captured in AD0005 and AD0006?

Or in which scenario rules (AD0033 - AD0036) will work in Pinnacle21 validator.


Thanks in Advance!



Kumaran Selvaraj


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!