AD0034 PMDA Check Issue

Sergiy

on December 6, 2021

P21

Hi Monica,ADaM-IG 1.0 does…

Hi Monica,

ADaM-IG 1.0 does not include OCCDS data structure. Therefore, your ADAEDEV dataset being not ADSL or BDS is validated as ADaM OTHER with a set of generic ADaM rules including AD0034. 

P21 validation engine has a special set of validation rules for ADAE dataset. It is also includes AD0034 rule.

A difference is in definition of ADAE and ADaM OTHER data structure. For engine to  compile executable rule, all variables involved in the algorithm should be present in both dataset and definition of standard structure. For example, standard structure for dataset should include definition of variables like ITTPFL or *PFL. Otherwise, AD0034 rule will not be complied for validation. This is exactly what happened for ADAE dataset which includes only FUPFL and AOCCPFL standard variable with *PFL suffix. AD0034 rule would work for them, but not for PPFL variable, which is not standard and not defined for ADAE structure.

ADaM OTHER is a special case. This data structure means any ADaM compliant dataset which is not defined ADAM-IG. P21 engine consider any non-standard dataset with name prefix "AD" as ADaM OTHER. In ADaM-IG 1.0 validation for OCCDS is executed as for ADaM OTHER. We consider this as a temporal solution before moving to ADaM-IG 1.1+ versions. PMDA agrees with such approach. Other users also requested to have at least something for validation of OCCDS datasets in ADaM-IG 1.0.

There is no option to define "standard" structure of non-standard dataset ADaM OTHER. Therefore, P21 validation specifications assume that any variable may present in ADaM OTHER dataset. We have it as * variable. Therefore, AD0039 rule will be complied for any *PFL variable in ADaM OTHER dataset (which covers OCCDS in ADaM-IG 1.0) including your case of PPFL variable.

I hope it helps.

Kind Regards,
Sergiy

P.S. All my talk above is about current PMDA 1810.3 engine. 

Thank you

Thank you so much, this is very helpful!