The MedDRA (Medical Dictionary for Regulatory Activities) browser allows you to encode diseases, signs, symptoms and indications.
Hover Utilities and click MedDRA Browser.
The MedDRA Browser screen appears.
If your Argus Safety Administrator has configured the system to use the MedDRA browser for encoding events or indications, enter a term and click Encode from the respective section.
You can also invoke the MedDRA browser while creating Advanced Conditions.
Tip:
When loading the new MedDRA dictionary, the system selects the default MedDRA browser..
Field | Description |
---|---|
Terminology | Allows you to select the version of the dictionary in which you wish to encode this event. |
MedDRA SMQ | Select a category from the available Standard MedDRA Queries (SMQs). |
Search All Levels | Enter text in this field and press ENTER to search for text across all of the five levels of the dictionary. |
Full Search | If you check this checkbox, the search text you enter will be matched within each word of the terms. If this checkbox is unchecked, the system will only return the terms that begin with the text you entered. |
Include Non-current terms | When you check this checkbox, the system retrieves the matching Non-current terms along with the Current terms. Enabled only when the MedDRA Browser is used for searching on local MedDRA dictionaries. |
SOC | System Organ Class. You can enter text in this field to search for the term in this particular level. |
HLGT | High Level Group Term. You can enter text in this field to search for the term in this particular level. |
HLT | High Level Term. You can enter text in this field to search for the term in this particular level. |
PT | Preferred Term. You can enter text in this field to search for the term in this particular level. |
LLT | Low Level Term. You can enter text in this field to search for the term in this particular level. |
Synonyms | This level can list company-specific synonyms for LLT terms. |
Creates a report of the information that is currently on the dialog box. This report will be in the PDF format. | |
Select | Click this button to enter the terms that have been selected into the encoding. |
Export | This button is enabled in two scenarios - when MedDRA is opened from: i) Argus Console > Business Configuration > Products and Licenses > Product Family > Datasheet or, from: ii) Argus Console > Code Lists > Argus > Event Groups MedDRA terms are selected at any level of the MedDRA hierarchy. On clicking this button, a dialog box is displayed, that allows you to select the file type - .csv / .xls / .xlsx file. On specifying the file type, the selected PT terms are then exported in the Export file. in the <PT terms> format. |
Enter the required term in one of the five levels of encoding.
You can enter as little information as necessary to get a broader set of results. Alternatively, you can enter the term under Search All Levels to search for the term across all levels.
Check the Full Search checkbox, if necessary.
Press Enter.
A list of search results appears.
Click Select to transfer the selected terms to the Case Form or the Advanced Conditions dialog box, depending on where the browser was invoked from. The button only becomes available after terms at all levels have been selected.
If you double-click an LLT term, a Term Details dialog box appears. The dialog box displays the following details about the term:
Indicates if the term is current or non-current
MedDRA code for the highlighted term
Primary SOC code and term
Dictionary Name and version number
When you select a term in a particular column, the other columns will be filled-in with the appropriate terms that correspond to the selected term.
The Primary SOC Path is highlighted by using bold text for the path.
To perform a synonym search, select an LLT among the search results. A synonym for the LLT will appear in the Synonyms column. When you select a synonym, the LLTs for that synonym will appear in the Synonyms column.
Non-current terms:
Non-current terms are flagged at the LLT level within MedDRA.
These are not recommended for continued use but are retained within the terminology to preserve historical data for retrieval and analysis.
Terms that are vague, ambiguous, outdated, truncated, or misspelled.
Terms derived from other terminologies that do not fit MedDRA rules.
The Include Non-current Terms option in the MedDRA browser allows users to expand their search results on local MedDRA dictionaries to non-current terms too.
The Non current LLT terms are displayed preceded with an asterisk (*) symbol separated by a space, in the search results grid as well as bottom section which displayed the selected term details. On clicking on non current term, the system displays its PT, HLT, HLGT, and SOC terms.
If MedDRA J is not configured, only the English currency is used.
If MedDRA J is configured and MedDRA Browser is opened from a Japanese base language screen, then only Japanese currency is used.
If MedDRA J is configured, MedDRA Browser is opened from an English base language screen (for English as well as Argus J user), and Country of Incidence is Japan, then English as well as Japanese currency is used.
If MedDRA J is configured, MedDRA Browser is opened from an English base language screen (for English as well as Argus J user), and Country of Incidence is not Japan, then only English currency is used.
On selecting a noncurrent term in the MedDRA browser by clicking Select button, the following message is displayed:
Selected term is a non-current term in the MedDRA dictionary. Please select a current term.
The MedDRA Browser print PDF also displays the asterisk (*) symbol in front of the non-current LLT.
The MedDRA Recoding tool displays the following options for each case with the existing data elements after the case number in the XLS export or tab delimited file:
Current Workflow State
Current Workflow Group
If Excel is the output format and the number of records returned is more than 60K, the system splits the record set into multiple worksheets of 64K each.
These options are available for the end user logs.
The SOC/HLGT/HLT/PT/LLT and Synonym columns in the MedDRA schema and the MedDRA table have been expanded to 250 characters to conform to the ICH guidelines.
The MedDRA Recoding Tool is configurable as per customer requirements.
The following is the list of tables that support MedDRA Recoding and their locations in the Argus application.
Argus Database Table | Location in Argus |
---|---|
CASE_PAT_HIST | Argus Safety > Case Form > Patient Tab > Parent Section > Other Relevant History |
CASE_EVENT | Argus Safety > Case Form > Events Tab > Event Information |
CASE_PROD_INDICATIONS | Argus Safety > Case Form > Products > Products Indication |
CASE_ASSESS | Argus Safety > Case Form > Events Tab > Event Assessment > Event PT (Description)/LLT |
CASE_DEATH_DETAILS | Argus Safety > Case Form > Events Tab > Seriousness Criteria > Death Details > Cause of Death & Autopsy Details |
CASE_LAB_DATA | Argus Safety > Case Form > Patient Tab > Lab Data |
LM_ALWAYS_SERIOUS_TERM | Argus Console > Code Lists > Always Serious Term List |
LM_LABELED_TERM | Argus Console > Business Configuration > Products and Licenses > Datasheet |
LM_PRODUCT | Argus Console > Business Configuration > Products and Licenses > Primary Indication |
LM_LAB_TEST_TYPES | Argus Console > Code Lists > Lab Test Type |
The following logic is used during the MedDRA recoding:
Get the Lower Level Term (LLT).
Check LLT_Code column in the MEDDRA_PREF_TERM_LLT table to see if LLT is not current (LLT_CURRENCY = N).
Decisions:
If LLT cannot be found in MEDDRA_PREF_TERM_LLT then record as exception to be noted in LOG file.
If LLT is not current then get PT_CODE from MEDDRA_PREF_TERM_LLT and use as LLT (Each PT exists as LLT also - always).
If LLT is current then keep LLT as it is.
If a current LLT can be found in previous step then continue with next step else go to 1 and select the next set of Terms.
Based on the LLT, get the Preferred Term (PT_CODE) from MEDDRA_PREF_TERM_LLT. Get the rest of the hierarchy from MEDDRA_MD_HIERARCHY, based on PT_CODE and PRIMARY_SOC_FG = 'Y'.
Match all 5 levels of Code and Description and update the data, if required.
Populate the following columns:
DICT_ID = Current MedDRA Dictionary ID, present under Case Form Configuration.
CODE_STATUS = 1 (displaying that this set of terms has been encoded).
For multi-tenant environment, the MedDRA Re-Code Tool allows recoding of MedDRA terms at the Enterprise level.
The MedDRA recoding tool displays an additional multi-select list of all active Enterprises. This lists all active Enterprise Short Names in the alphabetical order.
New Schema Owner is no longer required. As per the recoding logic, cases are also re-coded to the MedDRA version that is configured in Console.
Displays a note below the Existing MedDRA Version to Re-Code list - Note - Cases will be re-coded to the MedDRA version configured in Console for the respective Enterprises.
The MedDRA recoding tool only re-codes the items that match the selected Enterprises and values selected in the Existing MedDRA Version to Re-Code list.
The log file specifies the Enterprise Short Name with every log record that is processed for a particular Enterprise.