ADaM

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?

Hi,

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!

Regards,

Kumaran Selvaraj

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.

Hi,

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. 

Hi!

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.

Hi!

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!

Manolya

Hi,

What should be the Class value for ADAE dataset. I have given OCCURRENCE DATA STRUCTURE and getting an error(DD0055,Invalid Class value) in pinnacle report.

Kindly provide your comments.

Thanks in advance!!

Hi,

I am getting an error (Unknown NCI Code value for Codelist 'DATEFL' and Unknown NCI Code value for Codelist 'TIMEFL') in pinncle report however, I have assigned correct NCI Codelist Code and NCI Term Code for the same. Please see the attached file with example. 

Thanks in Advance!!

Hi!

When the ADaM 1.1 checks are out for the community, will there also be a cross check between ADaM and SDTM? The ADaM validation rules require DM, EX, and AE for some checks, but no errors are thrown out if you don't include the SDTM datasets. Is this because of the community version of Pinnacle?

Thank you in advance!

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. 

thks,

neha