Reason for addition of error check: SD1029 to V1.3

j Jhelum

on April 18, 2012

Hi OpenCDISC Team,

The error check SD1029 was added in the recently released v1.3 of the OpenCDISC Validator.

The rules define it as:

SD1029

Message:

Non-ASCII or non-printable characters

Description of Rule:

Character variable value must not include non-ASCII or non-printable characters (outside of 32-127 ASCII code range)

Can you please let us know the underlying reason for addition of this check? (i.e change in FDA Submission guideline/requirements?)

Also, if possible can you provide a link to the guidance document that prompted this change?

We appreciate your help on this issue,

Sincerely,

Jhelum Naik

Forums: SDTM

s Sergiy

on April 20, 2012

Hi!

Sergiy

We're eager to share and ready to listen.

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