Issues noticed with Pinnacle 21 Community Version 2.2 related to DU (Device in Use) Domain

Pinnacle 21 Support SDTM
1

Hi Sai,

Thank you for reporting this issue!

We are already aware of it and have fixed incorrect Variable Labels.

Kind Regards,

Sergiy

2

Hi Sergiy,

Can you please let me know what was the Pinnacle 21 version you have fixed the incorrect variable labels and please provide me with solution related to the DUSEQ as mentioned above?

Thank you,

Sai Krishna.

3

Hi Sai Krishna,

A fix will be available in the next release of Validator.

As of today, you can document these messages as a known bug in P21C 2v.2.0.

Kind Regards,

Sergiy

4

Hi Team,

I have encountered couple of issues when I ran Pinnacle 21 Community V2.2 on DU domain.

  • In DU domain there is only one record per USUBJID and DUSEQ =1 for all the subjects. When I ran Pinnacle 21 Community V2.2 it is throwing an “ERROR” SD1236- “Duplicate value for DUSEQ variable” for 99 records out of 100 records. I am not sure what Pinnacle 21 is looking for even though the records are unique. Let me know if I am missing anything here.

  • We have used following variable labels for DUTESTCD and DUTEST as per SDTMIG Medical Device V1.0

  • DUTESTCD = “Device In-Use Test Short Name”

  • DUTEST= “Device In-Use Test Name”

  • However we got a warning SD0063-“SDTM/dataset variable label mismatch”. When I checked SDTM MD in configuration file the label is different. If I use this label I know the warning will be suppressed, but as per the rule - SD0063 “Variable Label in the dataset should match the variable label described in SDTM IG. When creating a new domain Variable Labels could be adjusted as appropriate to properly convey the meaning in the context of the data being submitted.”

  • DUTESTCD = “Device In- Use Test Short Name”

  • DUTEST= “Device In- Use Test Name”

Looks like there is a space after the “-“ in the SDTM MD.xml file labels it is really not clear for us which variable label do we need to use. Please let us know. I would really appreciate your response.

Thank you,

Sai Krishna.