About the MedDRA Dictionary
Medical Dictionary for Regulatory Activities (MedDRA) is used for coding Adverse Events and helps facilitate safety and regulatory review of clinical data. For more information, please see section 6.3.1 of the Technical Conformance Guide.
Since MedDRA is only available through a commercial subscription, it’s not included as part of Pinnacle 21 Community Validator distribution and must be provided by you or your company.
When provided, the Pinnacle 21 Validator uses five files (listed below) from the MedDRA dictionary to perform coding compliance checks. The MedDRA dictionary includes more files but only the ones listed below are needed for validation.
pt.asc
soc.asc
llt.asc
hlt.asc
hlgt.asc
Multi-language Support
Our MedDRA validation supports both English and Chinese variants of the MedDRA dictionary. Support is enabled through the use of sub-folders:
enfor Englishzhfor Chinese
To install MedDRA using multi-language support, you need to manually build the installation package using the steps below:
Download both the English and Chinese .zip files from MedDRA directly
Create a new folder called
MedDRA_##_#and create two additional sub-folders within: (1)en(2)zhCopy the 5 files above from the English .zip file to the
ensub-folder.Optionally, you may also place a copy of these same 5 files in the parent folder as well for backwards compatibility when using older validation Engines.
Copy the 5 files above from the Chinese .zip file to the
zhsub-folder.
..\MedDRA_28_1
- \en
- hlgt.asc
- hlt.asc
- llt.asc
- pt.asc
- soc.asc
- \zh
- hlgt.asc
- hlt.asc
- llt.asc
- pt.asc
- soc.asc
- hlgt.asc
- hlt.asc
- llt.asc
- pt.asc
- soc.asc
Steps to Install
We have created this easy process for you to add your company’s licensed copy of MedDRA to Pinnacle 21 Community Validator.
From the validation screen, click "Install now" next to MedDRA.
Enter in which MedDRA version you would like to install (e.g. 20.1).
Browse and select the the folder you would like to install. Note: the folder must contain the files mentioned above.
Click Install.
After install is completed, click close.
After you have installed MedDRA, select which version to use from the dropdown. To add additional versions of MedDRA dictionary, click "More dictionaries" on the validation screen and then select the plus icon next to the dictionary. Repeat steps 2 - 5.
Note: to overwrite an existing version of MedDRA already imported, follow the same steps and select "yes" when prompted if you wish to overwrite.
