EGLOINC invalid error message

EGLOINC

Hello Team,

I addition: EGLOINC is in the FINDINGS class but I get this message when it is in my EG domain:

EG        VARIABLE    EGLOINC    SD0058    Variable appears in dataset but is not in SDTM standard

I think the message is extraneous, since it is allowable by by 3.1.2 IG.

David

--LOINC vs. EGLOINC

Are you sure EGLOINC is allowed in 3.1.2?

Looking at the IG 3.1.2, I find this variable only in appendix E: Revision history where it states that the variable was removed. Also you should make the distinction between the model and the UG, because in the model 1.2 it is indeed listed under the general findings class, but not as EGLOINC, as --LOINC. The principle here is similar to --SEV which is in the general events class, but if I remember correctly there is no MHSEV whereas there is an AESEV in the IGs.

Though it does state "but can be added back" in there (the IG that is, ;-)), so you could indeed say that it is allowed for.

On the other hand this is just a WARNING, not an ERROR, so you might be able to live with it and describe in your reviewers guide that issue SD0058 appears in the validation tool, but that it is OK really since you decided to add the variable because it was required for your purposes and it is allowed for by the general model- if it really was...

LOINC

Thank you for your response.

I can't find the text but at one time the IG stated that any variable in the Findings Class can be added to a Findings domain. However, in contradiction to this, I did find this text in the IG on page 127.

 The following Qualifiers would not generally be used in EG: --MODIFY, --BODSYS, --SPEC, --SPCCND, --FAST, --SEV. It is recommended that --LOINC not be used.

Therefore, I am going to go with your suggestion to leave it in as a Warning.

Regards,

David

RE: --LOINC vs. EGLOINC

The criticality of this finding, hence the necessity of a corrective action, may depend on whether the variable is populated.  If EGLOINC is populated, there just may be a valid, defendable reason for a sponsor to use it.  If it is always null, then an issue is much more likely.