5 Code an adverse event term

Which dictionaries does Argus Safety support?

Argus Safety supports MedDRA, MedDRA J, WHO Drug, and J Drug dictionaries. The application maintains a single version of each dictionary in the database.

In multi-tenant environments, each tenant can have its own versions of each dictionary. The J Drug dictionary is the only dictionary version that is common to all the tenants.

What is the MedDRA browser?

The MedDRA (Medical Dictionary for Regulatory Activities) browser is a utility that you can use to code a term such as a disease, sign, or a symptom with an internationally standardized medical term. This is a way to ensure consistent drug terminology in the Argus Safety application.

The MedDRA browser appears when you create an Advanced Condition (also known as a filter) or when you enter case details in the Adverse Event Form. You can also access the MedDRA browser from the Utilities menu.

What are the five levels of the MedDRA dictionary?

The MedDRA dictionary hierarchy is a categorization of medical terminology. The five levels of the dictionary are System Organ Class (SOC), High Level Group Term (HLGT), High Level Term (HLT), Preferred Term (PT), and Lowest Level Term (LLT).

The lower the level of the dictionary, the more precise the medical terminology becomes. Preferred Terms (PTs) represent medical terms you can use as the end result for coding.

For example, if the term to code is "queasy," the preferred equivalent medical term (PT) is "Nausea" in the context of the following hierarchy:

System Organ Class (SOC) = Gastrointestinal disordersHigh Level Group Term (HLGT) = Gastrointestinal signs and symptoms

High Level Term (HLT) = Nausea and vomiting symptoms

Preferred Term (PT) = Nausea

Lowest Level Term (LLT) = Feeling queasy

What is a synonym?

A synonym is a term or a combination of terms that nearly or exactly match the meaning of the term to code. Each organization defines its own list of synonyms for coding. To add a term to the list of synonyms, contact an Administrator.

What is autocoding?

Autocoding is an Argus Safety feature that Administrators can enable for terms to be automatically coded using the MedDRA dictionary. If autocoding is not enabled in the Argus Safety application, or if autocoding does not find a match for your term in the MedDRA dictionary, you must manually search and select a coding for your term in the MedDRA browser.

What happens if you don't enable autocoding?

If autocoding is not enabled in Argus Safety, you must manually search and select a coding for your term in the MedDRA browser.

What are Standard MedDRA Queries (SMQs)?

Standard MedDRA Queries are predefined sets of MedDRA terms that you can use to retrieve codings in the MedDRA browser. SMQs are developed and validated by the CIOMS Working Group and are updated for each MedDRA dictionary version.

What is a full search?

When you run a full search, the MedDRA browser retrieves terms that contain your search term in any word order and combination. Alternatively, MedDRA retrieves only terms that start with your search term.

What is a non-current term?

A non-current term is a term that you can no longer use for coding, but is retained in the Argus Safety database for historical data retrieval. A coding term can become non-current if it is vague, ambiguous, outdated, truncated, misspelled, or derived from a terminology that is incompatible with MedDRA.

Non-current terms appear next to an asterisk symbol (*) at the LLT level in the MedDRA coding browser and in the search results list.

How can I view details for a coded term?

To view details for a coded term such as the dictionary version it was coded against, or SOC, HLGT, HLT, PT, LLT level values, click the green check mark next to Event Coding on the Case Details or new Advanced Condition form.

How can I narrow my search in the MedDRA browser?

To narrow your search for a coding, you can use one of the following options in the MedDRA browser:

• To search for the term in a specific Standard MedDRA Queries (SMQs) category, select the category from the MedDRA SMQ drop-down list.To search for the term across all dictionary levels, enter the term in Search All Levels and press the Enter key on your keyboard.To search for the term against any combination of terms that includes your term, check Full Search.To search for the term also against codings that may not be included in the selected dictionary version, click Include Non-current terms.

Why does a dictionary coding appear highlighted in yellow in the MedDRA browser?

A yellow highlighted coding in the MedDRA browser represents the primary System Organ Class (SOC) path for a term with more than one path or SOC.

Why can't I use the Export button to export a coding?

The Export functionality is reserved for Administrators.

What is Null Flavor data?

Null Flavors are used to describe the reason for missing data. ICH E2B (R3) and regional agencies such as CBER, EMA, and PMDA have published guidelines on the allowed Null Flavors for various fields that are part of the E2B (R3) report. A Null Flavor set is a collection of Null Flavors. Sets are provided by default for various combinations of Null Flavors in the Flexible Re-categorization Codelist.

Null Flavor data can be selected for fields in the Case Form by clicking on the Null Flavor button ( ) next to the fields. On clicking the button, a drop-down list appears and allows you to select Null Flavor data as configured in the Field Properties Configuration in the Argus Console. The background color of the NF button changes (from grey to blue) when a Null Flavor is selected from the drop-down list.

When the Case Form field has data and the user clicks the button, the system displays a warning message that data will be cleared on switching to the Null Flavor field. The data is cleared or retained based on user confirmation. When data pertaining to the field is received, Null Flavor data can be overwritten by actual data by clicking the NF button.

Autocoding is not enabled in my application

If your Administrator did not enable autocoding in the application, you must manually search and select a coding for your term in the MedDRA browser.

Autocoding is unsuccessful

If your Administrator enabled autocoding, but autocoding did not find a coding from the MedDRA dictionary for your term, the MedDRA Browser dialog box appears on the screen for you to manually search and select a coding for your term.

To attempt autocoding a second time, refine the description of your search term in the LLT field using a wildcard character (%), an alternative term, or a company-specific synonym that matches your term.

The application populates the fields in the Event Coding section with the details of a MedDRA coding match.

I receive a "No Records Found" message when I manually code a term

If you received a "No Records Found" message when manually coding your term in the MedDRA browser, you can refine the description of your search term in the LLT field using a wildcard character (%), an alternative term, or a company-specific synonym that matches your term.

The coding I previously used for a term now features an asterisk and can no longer be selected in the MedDRA browser, as it is labeled as non-current

If one of your active cases contains an adverse event term that has been coded with a term that now appears next to an asterisk symbol (*), you must code the term a second time for the respective case, or ask an Administrator to recode the term for you using the MedDRA recoding tool.