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

Pinnacle 21 Support SDTM
1

Hi!

See http://www.opencdisc.org/forum/sd1029-extended-ascii-not-allowed-where-regulatory-requirement

Sergiy

2

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