| Short Name |
Type mismatch for LBORNRLO and LBORNRHI
|
|---|---|
| Affected Standard |
SENDIG v3.0
|
| Description of Error |
The SENDIG v3.0 indicates the Type for the LBORNRLO and LBORNRHI variables is "Num". However, the correct Type as prescribed by the SDTM is "Char". |
| Efforts to Correct Error |
In SENDIG v3.1, the Type of these variables was updated to be 'Char' for consistency with the SDTM. |
| Concerned Published Element | Concerned Published Attribute | Published Attribute Value | Revised Attribute Value |
|---|---|---|---|
|
LB.LBORNRLO
|
Type
|
Num
|
Char
|
|
LB.LBORNRHI
|
Type
|
Num
|
Char
|
| Impact of Issue | Coping Strategy |
|---|---|
|
Both presentations are being used for SEND v3.0 datasets across the industry, some choosing to match the SENDIG V3.0 and others to match the SDTM. |
Data receivers may expect to receive the data types for LBORNRLO and LBORNRHI as either "Num" or "Char". |
|
Data preparers who use data type of "Num" for LBORNRLO and LBORNRHI may see validation errors or warnings. |
Data preparers who use data type of "Num" for LBORNRLO and LBORNRHI should be prepared to explain the reason for the validation errors or warnings in the Non-clinical Study Data Reviewers Guide (nSDRG). |