| Short Name |
Core Values for MIBLFL, MILOBXFL, MOBLFL, and MOLOBXFL
|
|---|---|
| Affected Standard |
SDTMIG v3.3
|
| Description of Error |
The --LOBXFL (Last Observation before Exposure) variable was introduced as a Findings Domain qualifier with the intent of eventually replacing --BLFL (Baseline Flag). In findings domains in which --BLFL was expected, its core value was to be changed to permissible, while --LOBXFL became expected. This was not carried out as intended for the MI (Microscopic) and MO (Morphology) domains. In the MI domain, MIBLFL is expected but should be permissible and MILOBXFL is permissible but should be expected. In the MO domain, MOBLFL is expected but should be permissible and MOLOBXFL is permissible but should be expected. |
| Efforts to Correct Error |
The core values will be corrected in the next version of the SDTMIG. |
| Concerned Published Element | Concerned Published Attribute | Published Attribute Value | Revised Attribute Value |
|---|---|---|---|
|
MI.MIBLFL
|
Core
|
Exp
|
Perm
|
|
MI.MILOBXFL
|
Core
|
Perm
|
Exp
|
|
MO.MOBLFL
|
Core
|
Exp.
|
Perm
|
|
MO.MOLOBXFL
|
Core
|
Perm
|
Exp
|
| Impact of Issue | Coping Strategy |
|---|---|
|
An MI dataset which does not include MIBLFL variable may result in a validation error or warning. |
If MIBLFL is not included in an MI datasets, explain any resulting validation errors or warnings in the Clinical Study Data Reviewers Guide (cSDRG). |
|
An MI dataset which does not include the MILOBXFL will flag baseline values in a way that is different from other findings domains, creating confusion for reviewers. |
Include MILOBXFL in MI datasets. |
|
An MO dataset which does not include the MOBLFL variable may result in a validation error or warning. |
If MOBLFL is not included in an MO dataset, explain any resulting validation errors or warnings in the Clinical Study Data Reviewers Guide (cSDRG). |
|
An MO dataset which does not include the MOLOBXFL will flag baseline values in a way that is different from other findings domains, creating confusion for reviewers. |
Include MOLOBXFL in MO datasets. |