07-01-2011 01:47 PM
When i put a SDTM domain through the open CDISC validator, it gives me a warning that the value of a pirticular variable lets say AESEV not found in controlled terminology. But the value actually is present in controlled terminology except that its all UPPER CASE. For example the value of AESEV in the domain is 'Moderate' instead of 'MODERATE' as in Controlled Terminology. Now i can convert the value to uppercase which is not an issue for me. But Will the FDA accept if i dont change it to uppercase and leave it just like that. It just looks better.
03-08-2013 02:35 PM
See e.g., SDTM IG v3.1.2 on page 35:
"220.127.116.11 CONTROLLED TERMINOLOGY TEXT CASE
It is recommended that controlled terminology be submitted in upper case text for all cases other than those
described as exceptions below. Deviations to this rule should be described in the define.xml.
a. If the external reference for the controlled terminology is not in upper case then the data should
conform to the case prescribed in the external reference (e.g., MedDRA and LOINC).
b. Units, which are considered symbols rather than abbreviated text (e.g., mg/dL). "