v2.1.2 SD0064/FDAN040: Subject is not present in DM domain

Pinnacle 21 Support Troubleshooting and Problems
1

Hi Debra,

This is a bug in v2.1.2 which affects only SEND validation.

It will be a new release soon. Now you can fix SEND specs by manual editing of SD0064 rule definition. On line #14626

<val:Condition ID=“SD0064” PublisherID=“FDAN040” Message=“Subject is not present in DM domain” Description=“All Subjects (USUBJID) must be present in Demographics (DM) domain.” Category=“Cross-reference” Type=“Error” Test="SUB:SITEID != ‘’" When=“USUBJID != ‘’”/>

Corrected:

<val:Condition ID=“SD0064” PublisherID=“FDAN040” Message=“Subject is not present in DM domain” Description=“All Subjects (USUBJID) must be present in Demographics (DM) domain.” Category=“Cross-reference” Type=“Error” Test="SUB:USUBJID != ‘’" When=“USUBJID != ‘’”/>

Let us know if you need help.

Sorry for inconvenience.

Kind Regards,

Sergiy

P.S. This bug is due to not up-to-date engine in 2.1.2, rather than due to an error in validation specs. So in a new release specs will still refer to SITEID variable.

2

Hi Sergiy,

When I tried doing it as you indicated, I can not fix the bug.

However, I can fix it to replace v2.1.2 SD0064 with v2.1.1.

v2.1.1:

<val:Lookup ID=“SD0064” PublisherID=“FDAN040” Message=“Subject is not present in DM domain” Description=“All Subjects (USUBJID) must be present in Demographics (DM) domain.” Category=“Cross-reference” Type=“Error” Variable=“USUBJID == USUBJID” When=“USUBJID != ‘’” From=“DM”/>

Regards,

Takayuki

3

The newest version appears to be using USUBJID, SUB:SITEID rather than USUBJID, SUBJID when cross checking within a SEND dataset. This is resulting in ERRORS in every domain except trial design and DM. This bug was not present in 2.1.1.