| Short Name |
LBSTREFC Core Attribute Should Not Have Been "Expected" in SDTMIG v3.3
|
|---|---|
| Affected Standard |
SDTMIG v3.3
|
| Description of Error |
LBSTREFC should not have been expected in SDTMIG v3.3. No use cases have been identified of laboratory tests which have a reference value rather than a normal range. Furthermore, a --STREFC value would be derived from an --ORREF value and LBORREF is not included in the domain specification for the LB domain. |
| Efforts to Correct Error |
LBSTREFC was removed from the LB domain specification in SDTMIG v3.4. |
| Concerned Published Element | Concerned Published Attribute | Published Attribute Value | Revised Attribute Value |
|---|---|---|---|
|
LBSTREFC
|
Core
|
Expected
|
(LBSTREFC is not in the LB domain specification)
|
| Impact of Issue | Coping Strategy |
|---|---|
|
LBSTREFC is expected, even though it is almost certainly null for tests in the LB domain. |
Omit LBSTREFC in the LB dataset(s). Explain in the reviewer's guide why LBSTREFC was omitted, even though the omission caused validation errors, The explanation would be that LBSTREFC was omitted because it is uniformly null and was erroneously identified as an expected variable in SDTMIG v3.3. |
|
LBSTREFC is expected, even though it is almost certainly null for tests in the LB domain. |
Include LBSTREFC in the LB dataset(s). Explain in the reviewers guide that LBSTREFC was included because it identified as an expected variable in SDTMIG v3.3, even though the core value was erroneous. |