s SriGowri
on

 

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

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

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

 

 

  

 

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