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BarbaraPost
Fluorite | Level 6

Hello,

 

I'm looking for help on writing valid SAS XPORT files that should be validated by Pinnacle21 validator, and will be send to FDA, this SAS XPORT version 5 (SDTM 1.5). This is for clinical studies data export.

 

So far so good, I managed to get a file I think correct, but the validator still complains on "Non-unique value for TAETORD within ARMCD".

 

I attach the ta.xpt file. I think I correctly understood how to format the numeric fields to IBM mainframe format. So, my actual values for TAETORD are 1, 2, 3...

 

I have a comparative SAS XPORT 9.1 file provided with the Pinnacle21 validator but don't understand why some TAETORD records seem to have identical values, as far as I can see with my text ediitor.

 

I attach both files.

 

I'm a Windows user, program in C#, my company has no SAS software and will not afford a license. May you also advice me a text editor that is user-friendly at displaying the ascii code characters I encounter in xpt file?

 

Thank you very much for your help. I apologize if it's not the right community to ask to, please direct me.

 

Barbara

1 ACCEPTED SOLUTION

Accepted Solutions
BarbaraPost
Fluorite | Level 6

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-s...

View solution in original post

9 REPLIES 9
RW9
Diamond | Level 26 RW9
Diamond | Level 26

Hi,

 

I am afraid this is really outside the scope of this forum.  P21 is an opensouce tool for checking compliance against FDA/PMDA requirements, it is nothing to do with SAS.  Due to the requirements that FDA/PMDA have you do still need to use the very, very old SAS V5 XPT file format, however this is an open source format for many years, which is why it can be read by P21 (I know it would really make everyones life easier if they just made it all XML or something simple and text based).

As for the files you posted, I just tried to open them and it returns an error saying table does not exist or cannot be viewed.  Where was it created, with what software, on what system?  

Anyway, if there is data in those, then warning is something you would need to check with the data versus the Implementation Guide.

 

Shmuel
Garnet | Level 18

You can open the files using NOTEPAD++, then use menu VIEW-Wrap Word - to see it in lines (not one long record).

I'm have no experience with Pinacle or .xpt validation.

RW9
Diamond | Level 26 RW9
Diamond | Level 26

Is that with XPTs?  They are proprietary binary, so you would just see mostly strange characters.

Patrick
Opal | Level 21

@BarbaraPost

Using SAS I can open the ta.xpt in folder "pinnacle21 sample file" but I can't open the one in folder "programmatically generated file".

Opening the two files in Notepad++ they look different so there is likely something wrong with the generated file.

 

Not sure how one would create a .xpt file without using SAS.

 

If this is a one off then eventually - not sure about it - you could engage with SAS and have the .xpt created for you via the "Results as a Service" offering. 

https://www.sas.com/en_us/services/offerings/results-as-a-service.html 

 

Shmuel
Garnet | Level 18

@BarbaraPost, I don't know if next information can help you,

but trying to import the both xpt files to sas 9.4 I got next ERROR message:

 

ERROR: Unable to determine datasource type. Please use DBMS= option.

 

 

Patrick
Opal | Level 21

@Shmuel

I can open the file in folder "pinnacle21 sample file"

Capture.JPG 

Shmuel
Garnet | Level 18

@Patrick thank you. I see - xport is a sas engine. It is new for me.

 

 

BarbaraPost
Fluorite | Level 6

Thank you everyone for the various indications. Indeed, I will check the implementation guide again. As for my .xpt file not being readable into SAS, it may be an encoding problem. I generated a windows-1252 encoded file (to solve some characters writing), apart from being a V5 rather than a v9.x file. I programmatically created the file content with a C# program, since my main web application uses C# too.

 

Yes, with Notepad++ I can clearly read ascii code characters as little black blocks with the code inside and used the ascii codes table reference. So this is not so bad, I'll keep going with it.

 

So I close the subject.

 

Barbara

BarbaraPost
Fluorite | Level 6

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-s...

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