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). |
Known Issue Type