SD008 Value for AEDECOD not found in MedDRA dictionary Error 112

Pinnacle 21 Support SDTM
1

I do see 2 hits for term “Dizziness” in the SMQ Spreadsheet_14_1_English.xlsx and one in the pt.asc file. Is the problem case sensitivity ? Can you test your file with AEDECOD=’Dizziness’ and see if the error goes away ?

10066964$Procedural dizziness$$10022117$$$$$$$$



Anticholinergic syndrome (SMQ)





Broad

B

Dizziness

10013573


Hearing and vestibular disorders (SMQ)

Vestibular disorders (SMQ)

Broad

A

Dizziness

10013573

Also note that the definition of SD0008 specifies define.xml. Please ensure you did not override meddra with your own codelist in define.



ID

SD0008


ActiveUnless

%Variables[%Domain%DECOD].Define.WithCodeList%


Message

Value for %Domain%DECOD not found in MedDRA dictionary


Description

Value for the Dictionary-Derived Term (–DECOD) variable must be populated using a Preferred Term of the MedDRA dictionary or a version specified in the define.xml
2

We are using OpenDISC Validator 1.3 I have copied the licensed MedDRA Ascii files into their separate sub-folders (14.0, 14.1, 15.0 and 15.1) as instructed in your documentation “Configuring OpenCDISC Validator for MedDRA”. I get the following error:

SD008 Value for AEDECOD not found in MedDRA dictionary Error 112

It seems some of the values match up, yet others like AEDECOD=’DIZZINESS’ are missing and should be in the MedDRA dictionary as a Preferred term. The options selected in Open CDISC were:

Standard = SDTM

Source format = SAS Transport (XPORT)

Config = Config-sdtm-3.1.2.xml (tired config-sdtm-3.1.2-amend-1.xml and got the same error)

Report format = Excel

medDRA = 14.1

Any suggestions to resolve these issues are much appreciated as I cannot find a cause or solution. BIG thanks!