Medical History MedDRA coding issue

Hi Ankur,  Starting SDTM IG

Hi Ankur, 

Starting SDTM IG 3.1.3, MedDRA coding should be stored in Events domains, rather than SUPPQUAL.

There is an inconsistency in the OpenCDISC v1.3 SDTM IG 3.1.2 Amend 1 profile. SD0006 check applies only to SUPPAE, SUPPMH and SUPPCE domains. However new MedDRA varaiables are defined only for AE domain, but they are not added into MH and CE domains.

If you use the SDTM Amend 1 standard, then my recommendation would be to store MedDRA info in MH domain and comment  SD0058 Warnings for your MedDRA variables as "a well-known OpenCDISC v1.3 SDTM Amend 1 bug".

Thank you, 

Sergiy Sirichenko

OpenCDISC team

Medical History MedDRA coding issue

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The Assumptions for MH domain on Page 112 of the SDTM IG V3.1.3 suggest that Coding variables are to be mapped to SUPPMH; whereas the Amendment to SDTM 3.1.2 suggests that they should be included within the parent domain. Although they are currently being incorporated only in the AE Domain model, the Amendment says on page 3: "Additions to Section 2.2.2: The Events Observation Class: Add the following variables:" and it lists out the coding variables like LLT LLTCD etc. This causes some confusion as to whether we should add them to the MH domain too or just AE. What further adds to the confusion is that, the section 2.4 of the Amendment to SDTM IG 3.1.2 states that the QNAM and QLABEL values that pertain to coding like LLT, HLGT etc. should be removed from SUPPQUAL datasets since they have been replaced by variables in the Events general observation class. If the assumption is incorrect we suggest that it be removed from the MH domain and /or modified to read that coding variables should be added to the domain if MH is being coded for the study.

Hi Soumya,  SDTM IG 3.1.3 was

Hi Soumya, 

SDTM IG 3.1.3 was not updated well to be 100% compliant with a new Study Data Tabulation Model v1.3.

One of the basic general SDTM rules is to put collected information into dedicated locations. SDTM 3.1.3 has special variables in Events domains for MedDRA Coding. Those variables should be used instead of SUPPQUAL domains.

Kind Regards, 

Sergiy