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Preparing files from an SDTM-based system to import to OC

Dear OC Community,

We have some old files from Oracle Clintrial that are already in SDTM format. We’d like to convert these to a form in which we can import them into an OC system. There would be no further studies carried out with the data, but for the purposes of storage, we’d like to retain the data and access them from OC, in the ODM format. I realize that these are standards and not filetypes, so forgive my loose usage of the word “format.”

There seem to be a number of utilities/methods for going from the ODM format to the SDTM, but scarcely any to go in the other direction. I understand that proceeding from SDTM to ODM will strip away a lot of the metadata which was put in by Clintrial, but this is the requirement that I have.

I have looked into using “PROC CDISC” in SAS, but it seems as though that can import the ODM files to convert them to SDTM, but perhaps not go in the other direction.

What are my options besides writing a custom XML mapping/converter? Does such a utility already exist?

Kind Regards,
Jonathan Scabich

Comments

  • ccollinsccollins Posts: 378 admin
    Hi Jonathan,
    You may find the community-contributed tools available for importing flat-file data helpful, particularly OCDataImporter. You can find them here:
    https://wiki.openclinica.com/doku.php?id=publicwiki:dataimporttools
    Best,
    Cal
    On Wed, Mar 27, 2013 at 8:50 AM, Jonathan Scabich wrote:
    Dear OC Community,

    We have some old files from Oracle Clintrial that are already in SDTM format. We’d like to convert these to a form in which we can import them into an OC system. There would be no further studies carried out with the data, but for the purposes of storage, we’d like to retain the data and access them from OC, in the ODM format. I realize that these are standards and not filetypes, so forgive my loose usage of the word “format.”

    There seem to be a number of utilities/methods for going from the ODM format to the SDTM, but scarcely any to go in the other direction. I understand that proceeding from SDTM to ODM will strip away a lot of the metadata which was put in by Clintrial, but this is the requirement that I have.

    I have looked into using “PROC CDISC” in SAS, but it seems as though that can import the ODM files to convert them to SDTM, but perhaps not go in the other direction.

    What are my options besides writing a custom XML mapping/converter? Does such a utility already exist?

    Kind Regards,
    Jonathan Scabich
  • jscabichjscabich Posts: 3
    Cal,
    I think that will come in handy! We’ll give it a test run. Thanks so much.

    Sincerely,


    Jonathan Scabich
    MCRA
    Sent: Monday, April 15, 2013 9:41 PM
    To: [email protected]
    Subject: Re: [Users] Preparing files from an SDTM-based system to import to OC

    Hi Jonathan,

    You may find the community-contributed tools available for importing flat-file data helpful, particularly OCDataImporter. You can find them here:
    https://wiki.openclinica.com/doku.php?id=publicwiki:dataimporttools

    Best,
    Cal

    On Wed, Mar 27, 2013 at 8:50 AM, Jonathan Scabich wrote:
    Dear OC Community,

    We have some old files from Oracle Clintrial that are already in SDTM format. We’d like to convert these to a form in which we can import them into an OC system. There would be no further studies carried out with the data, but for the purposes of storage, we’d like to retain the data and access them from OC, in the ODM format. I realize that these are standards and not filetypes, so forgive my loose usage of the word “format.”

    There seem to be a number of utilities/methods for going from the ODM format to the SDTM, but scarcely any to go in the other direction. I understand that proceeding from SDTM to ODM will strip away a lot of the metadata which was put in by Clintrial, but this is the requirement that I have.

    I have looked into using “PROC CDISC” in SAS, but it seems as though that can import the ODM files to convert them to SDTM, but perhaps not go in the other direction.

    What are my options besides writing a custom XML mapping/converter? Does such a utility already exist?

    Kind Regards,
    Jonathan Scabich
This discussion has been closed.