Updating Coding Information for Dictionary Changes

Before you upgrade your application to the latest dictionary, make sure you set the following privileges and proceed with the tasks listed in the table:

Coding system set to agEncoder.
Dictionary Impact analysis must be concluded at the agEncoder
Select the option Impact analysis and Decision making screen in ARISg/j in Dictionary Upgrade tab

Action	Result
1. Select Tools to click Impact Analysis.	The drop down appears. The Impact Analysis drop-down list includes the option "Impact analysis report" for generating the Impacted Cases Audit Report and Non Impacted Cases Audit Report. Based on the selection criteria you enter in the Selection criteria page, the application generates the Impacted Cases Audit Report in the PDF format. Before generating the Impacted Cases Audit Report, the impact analysis is performed on each case, and specific action is initiated against the cases based on result of the impact analysis. Accordingly, the list of cases are printed in the Impacted Cases Audit Report on the basis of action under the following group: Ignored Recoded in same version Recoded and version incremented In the Non Impacted Cases Audit Report, list of cases are printed under the following action group: Upgraded
2. Choose MedDRA English dictionary.(applicable for Japanese MedDRA also)	Dictionary version screen appears.
3. Select the reference and Comparison versions on which Impact Analysis needs to be performed. For example: MedDRA version 9.0 from the reference drop down (MedDRA version currently supported by the application) and compare it with the MedDRA version 12.0. 4. Click Next.	The Impact Analysis Status screen appears for MedDRA English / Japanese dictionaries. This screen will show the progress of Impact Analysis. Refer the Impact Analysis status section for more information on the Impact Analysis status screen. For WHO DD dictionary the IA cases will be displayed directly.
5. Click the View Impacted Cases button in the IA status screen, to view the impacted cases for MedDRA English and Japanese	ARISg application receives information from agEncoder on the impacted cases and displays in MedDRA English/Japanese Impact Analysis and Recoding screen. It displays all the impacted case details with the change reason in the Case information tab.
6. To retain the existing code for an AER(s), click Ignore button in the Case information tab on selecting AER(s). Select case LAL-17 from the list and click Ignore button.	The application ignores and retains the case with the old information. Open the same case from the workflow and click Event tab, you find LLT and PT codes having information from MedDRA version 9.0. The information is retained in the application.
7. To recode the existing information, Select AER(s) and click Recode button. Select LAL-20 from the list and click Recode button	The application displays a message asking you to confirm on updating the impacted case with the new information. Click Yes to proceed. List the same case in the Workflow Status window to find the coding status as resolved. Open the case and click the Event tab, you find LLT and PT codes contain information from MedDRA version 12.0.

Criteria for Coding records in new version of a case

Criteria	Result
When you set the admin parameter Create new AER version on recoding to Yes	You will have an option to code record(s) in the same version or in the new version of a case from Impact analysis screen.

Impact Analysis status

In ARISg, when the MedDRA version is upgraded to a new version, several verbatim terms are automatically updated according to changes available in the new version. The AERs contain LLT and PT code information that was coded using the earlier MedDRA version. It is necessary to identify the AERs that were affected because of upgrading the MedDRA version.

Impact Analysis process in ARISg helps you identify the cases (s) that were affected due to upgrading the MedDRA version.

At a given instance, you can initiate impact analysis between multiple MedDRA versions. The progress in impact analysis process between MedDRA versions is displayed in the "MedDRA English Impact Analysis Status/MedDRA Japanese Impact Analysis Status" page respectively.

Depending on the impact analysis status scenarios, this page is displayed after you select the MedDRA versions for analysis in the "Select Dictionary and Versions" page and click Next.

In the following scenarios ARISg display the MedDRA English Impact Analysis Status/MedDRA Japanese Impact Analysis Status:

If the MedDRA impact analysis is performed for the first time for the selected MedDRA versions, after the impact analysis is complete, the View Impacted case (s) button is enabled. Clicking this button displays the MedDRA English/Japanese Impact Analysis and Recoding screen where the impacted cases are listed.
When you directly open the MedDRA English/Japanese Impact Analysis and Recoding screen for which the MedDRA version impact analysis is already performed, the message ”Impact analysis for the selected dictionary versions is in-progress. Do you wish to re-compute and overwrite the previous analysis?” is displayed:
- Yes - Displays the MedDRA English Impact Analysis Status/MedDRA Japanese Impact Analysis Status page and recomputes the impact analysis, and overwrites the previous analysis. The appropriate status is displayed after the analysis is complete.
- No - Displays the MedDRA English Impact Analysis Status/MedDRA Japanese Impact Analysis Status page and appropriate status is displayed after the analysis is complete.
If the MedDRA impact analysis for the selected MedDRA versions has failed this page is displayed with the appropriate status and the application automatically recomputes the MedDRA impact analysis.
If the MedDRA impact analysis is in progress and exceeds more than 60 minutes, the message ”Impact analysis for the selected dictionary versions is in-progress. Do you wish to re-compute and overwrite the previous analysis?” is displayed:
- Yes - Displays the MedDRA English Impact Analysis Status/MedDRA Japanese Impact Analysis Status page and recomputes the impact analysis, and overwrites the previous analysis. The appropriate status is displayed after the analysis.
- No - Displays the MedDRA English Impact Analysis Status/MedDRA Japanese Impact Analysis Status page and appropriate status is displayed after the analysis.

While performing the impact analysis, this page displays the status of the impact analysis. All the MedDRA versions (Reference and Comparisons versions) that are currently under impact analysis process are displayed in the tabular format with three columns as described in the following table:

Field/Button	Description
Reference Version	The MedDRA version already installed in ARISg with which the LLT and PT terms that were coded for cases.
Comparison Version	The latest MedDRA version with which you want to compare and update the LLT and PT terms of the cases.
Impact Analysis Status	Under this column, the application displays three different statuses: Start - This status shows that IA has been initiated. Inprogress - This status is displayed when the impact analysis of the selected combination MedDRA versions is in progression. Success - This status is displayed only after the MedDRA version impact analysis is complete. Failure - This status is displayed when the MedDRA version impact analysis fails.
Recode All Status	Displays the progress of the impacted cases which are sent to agEncoder for recoding.
View Impacted Case (s)	This button is enabled only when the impact analysis status is "Success" that after the impact analysis is successful. Clicking this button displays all the impacted cases in the MedDRA English/Japanese Impact Analysis and Recoding screen.
Pager	The application may be unable to list all the MedDRA versions status details in a single page. Hence, the statuses page may exceed one page. This field displays the page number which you are currently viewing.
Close	Close the Impact Analysis page.

Impact Analysis table

Field /button	Description
AER	Indicates the impacted AER
AER Ver #	The version of the AER impacted.
Verbatim Term	The precise word reported in the case.
Term Type	The type of terms impacted on performing the impact analysis by agEncoder application. ARISg application displays the following type of terms in the Case Information tab. Adverse Events Disease Terms Indication Terms Laboratory Tests Sender’s Diagnosis
LLT code	Indicates the corresponding code for the Low Level term available in the impacted AER.
Decode	Indicates the corresponding decode for the LLT code available in the impacted AER.
New MedDRA Version	Indicates the MedDRA version used for comparing and recoding the data.
Change Reason	Indicates the reason to change the LLT code on performing the Impact analysis by agEncoder application.
Ignore	Enables you to retain the old information in the case and also the MedDRA version.
Update non-impacted case(s)	Enables you to update the MedDRA version number, with the new MedDRA version for all the non_impacted cases.
Select all for Recode	Enables you to send all the impacted cases to agEncoder for recoding.
Export	Enables you to export the data to comma-separated values (CSV) file. You have the option of exporting the filtered data or the unfiltered data to CSV file or ASC(Unicode format).
Filter	You search the impacted records on the following fields: AER # AER Ver # Term type Change Reason Project # Protocol Number: Click the lookup icon to select the project # and protocol number to display the information in the impact Analysis screen. `
Recode Settings	Enables you to code the impacted terms for the following changed reasons: • Changed LLT Decode • Changed LLT-PT Link • Changed PT-SOC Link To code the impacted terms in ARISg based on selection: 1. Click the Recode Settings button and select any one of the reasons to be coded. 2. Click Save. In the Imapct Analysis screen select the record having change reason as 'Changed LLT Decode' and click Recode Settings button. The changed reason is displayed on the screen. The impacted terms are auto coded in ARISg system. The changed reasons which you have not selected and the additional change reasons such as ‘Direct Dictionary Match’, ‘Non-current LLT’ etc are sent to agEncoder for recoding.
Report	Enables you to generate report for the current impact analysis screen. This report displays all 1. The LLT terms used in cases which now have become non-current in the new dictionary version. 2. The terms used in cases which have direct matches to the new dictionary for the LLT term. 3. The cases terms which are now having different primary SOC terms in the new dictionary. 4. The cases for which WHO DD codes are deleted from the new dictionary.

Impact Analysis Status Screen

The Impact Analysis Status Screen lists the impact analysis status, recode-all status and update non-impacted record status for respective dictionary versions.

Impact Analysis status menu option is displayed in ARISg>Tools>Impact Analysis when the coding system is set to agEncoder in the Installation parameters.

Company Products Dictionary Records Tab (CPD)

When you are performing the impact analysis of MedDRA dictionary on CPD Library, the application compares the dictionary information (Indication information and AE's of Special Interest) maintained in the CPD Maintenance of Admin application with the information available in the new MedDRA version. The application considers the following "changed reasons" to determine the CPD records, which have impacted as a result of MedDRA upgrade.

Changed LLT code, decode
Changed PT code, decode
Change SOC code, decode
LLT non current
LLT – PT link change
Missing LLT
PT-SOC link change

Click Filter and select changed reason to display records depending on the selected changed reason.

Upgrading and Recoding Case Data using WHO Drug Dictionary upgrades

Action	Result
1. Select Tools to click Impact Analysis.	The drop down appears
2. Choose WHO DD	Dictionary version screen appears.
3 Select WHO Drug Dictionary from the reference drop down (being used in production currently) and compare it with the new WHO Drug Dictionary available in staging area. 4 Click Next	ARISg application receives information from agEncoder on the impacted cases and displays in WHO Drug Dictionary Impact Analysis and Recoding screen. It displays all the impacted case details with the change reason in the Case information tab.
5. To retain the existing code for an AER(s), click Ignore button in the Case information tab on selecting AER(s).	The application ignores and the case disappears from the List.
6.To recode the existing information, Select AER(s) and click Recode button. Select LAL-20 from the list and click Recode button	The application displays a message asking you to confirm on updating the impacted case with the new information. Click Yes to proceed. List the same case in the Workflow Status window to find the coding status as resolved. Open the case and click the Product tab, you find that the information is recoded.

Upgrading and Recoding Case Data due to Japanese Drug Dictionary upgrades

Generating Coding Metrics Report

The Coding Metrics report available in the form of an IView, displays the count of the following:

· The terms having a dictionary match along with a VTA match

· Manually coded terms

· Classified terms

· Terms whose coding is in progress and grouped by term type

You can configure the IView in the Homepage, depending on your privileges to the option Coding Metrics Report in Admin>Security>Roles & Privileges Maintenance>IView Access.

You can generate the Metrics report for a maximum of one month.

To generate:

On the Tools menu click Coding Metrics Report.
Enter From and To Dates.
Note: The application considers the current date and one month prior to the current date as the default date.
Click Go.
The agEncoder Coding Metrics Report is displayed.
Click the Coding Type.
The application displays the count, according to the term type.
Click the Term type.
The application displays the case details such as Verbatim term, AER NO, Version, LLT Decode, PT Decode, HLT Decode, HLGT Decode, SOC Decode and Term Type.
Click to print the report.
Click to export the data to a CSV file.
A message appears requesting you to save or open the file.
Click to view the data.

Impact analysis of the Cases Audit report

The MedDRA Dictionary versions are released periodically in which the Dictionary Code/Decode (LLT, PT, and SOC) terms are often revised or updated as per the global standards. It is necessary for the pharmacovigilance company to upgrade the MedDRA Dictionary to study the statistics of the AERs having the verbatim terms (LLT, PT, and SOC) terms that are impacted because of the MedDRA Dictionary upgrade.

In ARISg, there may be multiple cases with the Dictionary Code/Decode terms that were autocoded using the previous version of the MedDRA Browser. When you upgrade the MedDRA Dictionary to the latest version, the LLT and PT terms that are available in all the AERs are updated to the revised or updated Dictionary Code/Decode terms of the new MedDRA Dictionary version while upgrading.

Generating Impacted Case Audit Report and Non-impacted case audit report

For analyzing, the Impact analysis option is provided under ARISg > Tools menu to generate two types of report; Impacted Case Audit Report and Non-impacted Case Audit Report respectively using the selection criteria.

Impacted cases audit Report – This report displays all the AERs in which the Dictionary Code/Decode is modified/updated. The report displays the old and new values of the Dictionary code/decode.
Non-impacted cases audit Report - This report displays all the AERs in which the MedRA Dictionary version is upgraded but there is no impact on the Dictionary Code/Decode.

To generate the Impacted and Non-Impacted Case Audit Report:

Login into ARISg.
From the Tools menu, choose Impact Analysis and then click Impact Analysis Reports.
The Selection Criteria dialog box appears.
You have options to enter the criteria to generate Impact or Non-impact case audit report. For example: If you want to generate a report to study the list of AERs having impacted with upgrading the MedDRA Dictionary between two versions of the AER, then enter the two versions of the AERs in From AER# and To AER# box to generate the report of the cases having impacted between these two AER versions.

Based on the following search criteria the respective report is generated:

Criteria	Description
Verbatim Term	Enter the verbatim term to search for the cases that have been impacted because of change in this verbatim term. For example: If a verbatim term "Fever" existing in the current version of the Dictionary is recoded a "Feveree", then the report with all the AERs that are impacted or Non-impacted is generated.
From AER # and To AER#	The two versions of AERs between which you want to generate the list of AER those were impacted or non-impacted because of Dictionary upgrade. This is a mandatory field.
From date and To date	To consider the AERs which were created between From and To date for generating the impacted and non-impacted report. This is a mandatory field.
Dictionary Type	Select the Dictionary type depending on ARISg/j login: MedDRA English MedDRA Japanese This is a mandatory field.
From Dictionary version	The previous MedDRA Dictionary version. This is a mandatory field.
To dictionary version	The upgraded MedDRA Dictionary version. This is a mandatory field.
Report Type	Select the type of Case Audit report you want to generate: Impacted cases audit report Non-impacted cases audit report This is a mandatory field.

If you generate the report without entering any one of the mandatory field, the warning message Please select mandatory fields for report is displayed.

- Click OK. The mandatory field which you have not entered is highlighted with red border.

After you enter the selection criteria, click Generate.
The respective Impacted or Non-impacted cases audit report is generated.

Analyzing the Impacted cases audit report

In Impacted cases audit trail report the fields described in the following table are displayed in the tabular column:

Column name	Description
AER#	Indicates the impacted AER.
AER Ver #	The version of the AER impacted.
Verbatim Term	The precise word reported in the case.
Term Type	The type of terms impacted on performing the impact analysis by agEncoder application. ARISg application displays the following type of terms in the Case Information tab. Adverse Events Disease Terms Indication Terms Laboratory Tests Sender’s Diagnosis
Dictionary Code – Dictionary Decode
LLT code	Indicates the corresponding code for the Low Level term available in the impacted AER.
PT code	Indicates the corresponding Preferred term available in the impacted AER.
Date Created	The Date on which the AER was created.

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