Variable Labels more than 40 characters

Short Name
Variable Labels more than 40 characters
Affected Standard
SDTMIG v3.2
Description of Error

Variable labels listed below are more than 40 characters, but 40 characters is the maximum length of a label in the SAS v5 transport format required by regulators

Efforts to Correct Error

Variable labels no more than 40 characters in length are included in SDTMIG v3.3.


Concerned Published Element Concerned Published Attribute Published Attribute Value Revised Attribute Value
HO.HOTERM
Label
Reported Term for the Healthcare Encounter
HO.HODECOD
Label
Dictionary-Derived Term for the Healthcare Encounter
HO.HOSTDY
Label
Study Day of Start of Healthcare Encounter
MH.MHREASND
Label
Reason Medical History Not Done or Not Occurred
IS.ISSTRESC
Label
Character Results/Findings in Standard Format
MI.MISTRESC
Label
Character Result/Finding in Standard Format
PC.PCSTRESC
Label
Character Result/Finding in Standard Format
PP.PPSTRESC
Label
Character Result/Finding in Standard Format
PE.PESTRESC
Label
Character Result/Finding in Standard Format
QS.QSSTRESC
Label
Character Result/Finding in Standard Format
SR.SRSTRESC
Label
Character Results/Findings in Standard Format
FA.FALAT
Label
Laterality of Location of the Finding About

Impact of Issue Coping Strategy

Labels published in the SDTMIG v3.2 for these variables cannot be used.

Use a label no more than 40 characters in length, such as the label in SDTMIG v3.3.

Validation software may return errors or warnings for labels for these variables, since no label 40 or fewer characters long matches the label for the variable in the SDTMIG v3.2.

Explain any validation errors or warnings in the Clinical Study Data Reviewers Guide (cSDRG).