b Barbara
on

 

Hello,

I have to export study data in .xpt version 5 format (for submission to FDA). I develop it in C#.

So far so good, I have troubles understanding the remaining validation errors: Non-unique value for TAETORD within ARMCD

Please can someone help me understanding the correct format for TAETORD variable? It it described in SDTM 1.5 as a numeric value.

[EDIT] I think I have to convert the integer to the IBM mainframe number format, this gives me a byte[8], then I have to properly encode this. I'm testing encoding each of the 8 byte values to ascii chars.

[EDIT 2] Please see updated file with proper encoding of numeric values.

I saw that the validator correctly interprets some "human-readable" numbers in namestre record data so I went with it and use ascii codes when it it clear it only works with ascii codes. Not very clear for me though, as I am a "modern" POO programmer...

I also see that TAETORD values in the Pinnacle21 sample file are not unique... However, I didn't check whether SAS XPORT 9.1 in the sample file differs from SAS XPORT 5 I have to write, apart from headers.

I attach both files. Thank you for your help.

Barbara

Forums: SDTM

b Barbara
on August 23, 2017

I solved my number formatting issue, I was using a library that didn't the produced output. After some searching I got the solution: https://stackoverflow.com/questions/4550367/convert-from-ibm-floating-point-to-ieee-floating-point-standard-and-vice-versa

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