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I would discourage use of iso-8859-1 encodings at all; health authorities communicate with other countries' authorities, better stick to utf-8 generally for simplicity. The US-ASCII subset of utf-8 can be a compromise for submissions to FDA. |
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Motivation
Let's start the discussion about an alternative wording proposal for section
4.1.2.10
in the "FDA STUDY DATATECHNICAL CONFORMANCE GUIDE" found here:
https://www.fda.gov/media/143550/download
Currently (November 2020) the paragraph reads:
The goal is to be more specific about the file types that can be submitted as many have interpreted that paragraph that program files need to be submitted as
.txt
files.Am I correct that the actual constraint is that the files need to be:
iso-8859-1
encoding and notutf-8
.R
does not work but.r
would not workAlso would
.tar
be acceptable for a collection of ASCII files?Let's start the discussion here, I can update this first message with the agreed solution from the discussion thread.
Current discussion state
TBD
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