Invalid dataset name for split domain

s SriGowri

on October 23, 2019

Hi Siergy,

We are getting “Invalid dataset name for split domain” - ERROR which is expected as we are using FA stand alone and FACE datasets.

Seems it is expecting FAxx instead FA, however in real case it is not possible.

Even in my previous company we have the same issue where we are using FACE FAMH FAAE FACM and FA as stand alone.

As we have no choice team decided to provide rationale in cSDRG as we can’t fix this issue.

Is there a possibility to exclude this rule for FA dataset.

Thanks in Advance!

Sri

Forums: SDTM

Sergiy

on November 7, 2019

P21

You cannot use both FA and FACE datasets

Hi Sri,

You cannot use both FA and FACE datasets. Similar you cannot use both LB and LBHM.

If your FA domain consists of combined records from FACE, FAMH, FAAE and FACM datasets, then you need to keep split datasets in a special folder. It used only in case of very large size of FA domain which requires splitting into smaller datasets for better usability. See FDA Technical Conformance Guide for details.

If your split datasets are not related to FA and have additional records, then name of domains should be different. For example, custom ZA domain instead of FA.

Kind Regards,

Sergiy

s SriGowri

on November 23, 2019

Datasets not greater than 5GB

Hi Siergy,

Thank you very much for your answer.

In the current company all the standard specs were using only FA but not FAxx, however based on the OVRR guidance we recently implemented FACE for Vaccine trials .

Hence resulted in FA and FACE . Moreover these datasets are not greater than 5GB .

Team decided to write the rationale in cSDRG .

Best regards

Sri