# DD0113 Error in P21 for the SDTM Define **URL:** \ **Category:** Define.xml\ **Created:** [July 22, 2019, 1:44pm UTC](https://forum.certara.com/t/dd0113-error-in-p21-for-the-sdtm-define/1369 "2019-07-22T13:44:39Z")\ **Posts on this page:** 8\ **Page:** 1
**Author:** ![Sergiy](https://sea1.discourse-cdn.com/certara/user_avatar/forum.certara.com/sergiy/32/2553_2.png) [@Sergiy](https://forum.certara.com/u/Sergiy)\ **Post date:** [July 22, 2019, 6:19pm UTC](https://forum.certara.com/t/dd0113-error-in-p21-for-the-sdtm-define/1369/1 "2019-07-22T18:19:36Z")
Hi Bianca, For questions related to Enterprise version, please try our P21 Enterprise support resources. However, based on your description it sounds like you have multiple MedDRA references in your define. Kind Regards, Sergiy ---
**Author:** ![bianca.petcut](https://avatars.discourse-cdn.com/v4/letter/b/35a633/32.png) [@bianca.petcut](https://forum.certara.com/u/bianca.petcut)\ **Post date:** [July 25, 2019, 9:05am UTC](https://forum.certara.com/t/dd0113-error-in-p21-for-the-sdtm-define/1369/2 "2019-07-25T09:05:30Z")
Hello Sergiy, Yes, that is the case. But when I keep only one MedDRA references in define then P21 Community shows an error for the numerical variables with dictionary saying that “Codelist/Variable Data Type mismatch”. So I am bit confused. Am I supposed to have only one MedDRA references for both character and numeric variables with dictionary or not? Thank you! ---
**Author:** ![Sergiy](https://sea1.discourse-cdn.com/certara/user_avatar/forum.certara.com/sergiy/32/2553_2.png) [@Sergiy](https://forum.certara.com/u/Sergiy)\ **Post date:** [July 25, 2019, 7:51pm UTC](https://forum.certara.com/t/dd0113-error-in-p21-for-the-sdtm-define/1369/3 "2019-07-25T19:51:33Z")
Hi Bianca, Yes, it’s quite confusing. Recommendation is to populate a reference to MedDRA dictionary only for variables of text type and skip numeric variables. They represent a coded value of paired MedDRA variable. So, formally it’s enough to specify MedDRA for AEDECOD, AELLT, etc. and ignore AEPTCD, AELLTCD, etc. variables. Based on your initial post we identified a bug which will be fixed soon. Current version of the validator assumes only a single MedDRA dictionary in define.xml. That’s why you had your false-positive messages. A difference between Community and Enterprise validation results is due to different define.xml files you used for validation. They are not the same. Thank you, Sergiy ---
**Author:** ![bianca.petcut](https://avatars.discourse-cdn.com/v4/letter/b/35a633/32.png) [@bianca.petcut](https://forum.certara.com/u/bianca.petcut)\ **Post date:** [July 26, 2019, 8:59am UTC](https://forum.certara.com/t/dd0113-error-in-p21-for-the-sdtm-define/1369/4 "2019-07-26T08:59:29Z")
Thank you Sergiy! I will try this approach. Kind regards, Bianca. ---
**Author:** ![lexjansen\_1](https://sea1.discourse-cdn.com/certara/user_avatar/forum.certara.com/lexjansen_1/32/306_2.png) [@lexjansen\_1](https://forum.certara.com/u/lexjansen_1)\ **Post date:** [July 27, 2019, 12:53pm UTC](https://forum.certara.com/t/dd0113-error-in-p21-for-the-sdtm-define/1369/5 "2019-07-27T12:53:50Z")
Would it not be better to document a false positive in the Reviewer’s Guide, instead of avoiding an incorrect message by not specifying metadata that should be specified. Character variables that are controlled by MedDRA should have an external codelist reference. The purpose of metadata in a submission goes beyond satisfying validation software! Letting metadata decisions be driven by validation software issues does not seem a good practice. Lex ---
**Author:** ![kaja](https://avatars.discourse-cdn.com/v4/letter/k/ecd19e/32.png) [@kaja](https://forum.certara.com/u/kaja)\ **Post date:** [March 31, 2020, 3:46pm UTC](https://forum.certara.com/t/dd0113-error-in-p21-for-the-sdtm-define/1369/6 "2020-03-31T15:46:38Z")
I agree with Lex’s suggestion and it is a good practice to document the false positive in the Reviewer’s Guide than to adjust them in the metadata. Having said that I’m still seeing the bug of reporting false-positive messages even today by Missing MedDRA reference on the ‘AEBDSYCD’ variable. in the community version Variable, Expected Dictionary ID, Referenced Dictionary ID AEBDSYCD, CODELISTEC2, CODELISTEI1 Dictionary ID CODELISTEC2 is for a character variable and Dictionary ID CODELISTEI1 is for a numeric variable of MedDRA controlled dictionary. Please let me know if the bug needs to be fixed or am I using the wrong P21 version. I’m using version 3.0.2 Kaja ---
**Author:** ![bianca.petcut](https://avatars.discourse-cdn.com/v4/letter/b/35a633/32.png) [@bianca.petcut](https://forum.certara.com/u/bianca.petcut)\ **Post date:** [July 22, 2019, 1:44pm UTC](https://forum.certara.com/t/dd0113-error-in-p21-for-the-sdtm-define/1369/7 "2019-07-22T13:44:39Z")
Hi, When validating the SDTM Define with Enterprise version, I get the following issue that doesn’t show up in Community version: DD0113 Variable, Expected Dictionary ID, Referenced Dictionary ID AEBDSYCD, AEDICT\_F, AEDICT\_FN Missing MedDRA reference on ‘AEBDSYCD’ variable Variables --LLT, --LLTCD, –DECOD, --PTCD, --HLT, --HLTCD, --HLGT, --HLGTCD, --BODSYS, --BDSYCD, --SOC, and --SOCCD must reference MedDRA dictionary for regulatory submissions. Error This error shows for all AE and MH variables with dictionary. I first thought it has an issue with the fact that I have 2 dictionary ID’s(one for text and one for numeric variables) AEDICT\_F, AEDICT\_FN, and I updated macro to keep only one ID. This change then created an error in Community version validation: DEFINE Variable, CodeList, Variable DataType, CodeList DataType IT.AE.AELLTCD, CL.AEDICT\_F, integer, text OD0080 Codelist/Variable Data Type mismatch Consistency Error Does anyone know why is this happening, and what can I do to fix it? ---
**Author:** ![Jose\_Gonzalez](https://avatars.discourse-cdn.com/v4/letter/j/6de8d8/32.png) [@Jose\_Gonzalez](https://forum.certara.com/u/Jose_Gonzalez)\ **Post date:** [May 29, 2026, 4:12pm UTC](https://forum.certara.com/t/dd0113-error-in-p21-for-the-sdtm-define/1369/8 "2026-05-29T16:12:36Z")
It has been fixed, becasue still I have the same error. I should report it in the reviewer’s guide. Thanks.