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What is the difference in the file format previously used on tape and diskette submissions and the file format used for SDTM submissions?

April 26, 2017diskette file format sdtm submissions tape Used

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What is the difference in the file format previously used on tape and diskette submissions and the file format used for SDTM submissions?

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None. They are identical. Files previously formatted for use on tape and diskette submissions are accepted by the SDTM process without any changes. However, at present, the BSA E-Filing System accepts only ASCII-formatted batch submission files using SDTM.