Argus SafetyAggregate Reporting – Awareness

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Reports

Argus Safety has powerful system reporting capabilities that enable you to monitor product safety profiles, case progress, and company productivity during the case handling process. There are several different kinds of reports available in Argus. In this section, we will review:

• Aggregate Reports• Periodic Reports

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Aggregate Reports: Topics

• Working in the Library

• Running Case Data Analysis Reports

• Running CIOMS II Line Listings

• Working with Case Listings

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Aggregate Reporting

To access the available Aggregate Report types, go to the Reports menu bar of Argus Safety and select one of the three types of Aggregate Reports:

• Case Data Analysis• CIOMS II Line Listing• Case Listing

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System Reports Library

Saved (memorized) reports may be accessed from the System Reports Library.

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Case Data Analysis

The Case Data Analysis report enables the User to tabulate events or cases over time in Cross‐Tabular Fashion. There are many reporting field options and filter criteria to build your Case Data Analysis report, including Advanced Conditions.

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Generating a data report

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Generating graphic options

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CIOMS II Line Listing

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Case Listing

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Argus: Periodic Reports

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Periodic Reporting

In Argus, the user has the ability to create various periodic reports. Argus contains a searchable library for enhanced organization, structured templates, the ability to add cases not included in previous reporting period, and comprehensive output options.

In order to access the reports, go to the Reports menu bar of Argus Safety and select from the four types of Periodic Reports available:

• ICH PSUR Line Listing Reports• US NDA Periodic Reports• Clinical Trial Periodic (CTPR) Reports• US IND Periodic Reports

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Report Definitions

CTPRClinical Trial Periodic Report

PSURPeriodic Safety Update Report

IND Investigational New Drug

NDA New Drug Application

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Accessing Periodic Reports

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Periodic Reporting - PSUR: Topics

• Working with PSUR Submission Records

• Library configuration

• Running a PSUR Report

• PSUR Report Configuration

• Working with Advanced Conditions

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ICH Periodic Safety Update ReportThe Periodic Safety Update Reports (PSURs) are created on a periodic basis to enable regulatory authorities to monitor the safety of a marketed product. Requirements on the due date of periodic reports may differ for different regulatory authorities.

• The following are PSUR reporting outputs: • Report Configuration• Line Listing• Index of Cases• Cases missing Assessment (Useful during draft review)• FDA Supporting Reports• Line Listing Tabulation• Cumulative Summary• User Defined Summary Tabulations• Supporting CIOMS or MedWatch Report

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PSUR Submission Record

Folder Structure to locate desired

Report(s)

Report(s) are displayed based on selected

Folder

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Periodic Reports Library Configuration

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PSUR – Running a Report

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PSUR Configuration

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PSUR Configuration (cont.)Fi

lterin

g O

ptio

ns

Based on selected ingredients, indications and formulations, the available products are

displayed

These products will be included in the Periodic Report

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PSUR Configuration (cont.)

Date Range & Date CriteriaCurrent or Data Lock Point Version

Date Range & Date CriteriaCurrent or Data Lock Point Version

Specify which cases to include in the PSUR by:

1. Case Type2. Seriousness3. Expectedness4. Relatedness5. Health Care Practitioner

Flexible additional filtering to only include relevant cases

Ability to include “missed” cases from a previous reporting period

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PSUR Configuration (cont.)

Specify if standard ICH Line Listing is to be included.

Additional data elements can be added to the line listing in a

specified order Additional line listing options

Options for Line Listing:Source of MedDRA

Hierarchy• Level of the term• Dose text instead of

system computed regimen dose

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PSUR Configuration (cont.)

Available fields for sorting

Selected Line Listing groupings with sorting option and page break

Sort order for the inner

most grouping

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PSUR Configuration (cont.)

Comparison of events tabulation against a previous period

Optional reports for submissions to the FDA

Single Case submissions for electronic reporting with the “PSUR” header

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PSUR Configuration (cont.)

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PSUR Configuration (cont.)

Allows for an automated way to schedule PSUR reports based on a predefined schedule

Optionally, the reports can be generated x-days after the Data Lock Point

The group responsible for completing the PSUR report

This box lists the logic as defined, e.g. every quarter for the first 2 years and then annually until withdrawal of drug

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PSUR Configuration (cont.)

If "Share this report with other users" is not checked, only the user who created this report will be able to use it. The report will then not be available to other users.

Users with “Execute” privilege will only be able to run a report, but not modify it

Users with “Execute & Modify” privileges will be able to modify the report as well as execute it

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PSUR Configuration (cont.)

The “Templates” tab is for use with Argus Dossier, an add-on module (i.e. an additional module which will not be used in this phase of Argus roll-out) to allow

the complete publishing of any periodic report.

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Printing the PSUR

Provides Progress Update and indicates which tasks have been completed

Options displayed to run the NDA as “Final” or “Draft”

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Printing the PSUR (2)

PSUR now available for printing or saving

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Advanced Conditions

• Used to select a subset of cases throughout the Safety System, including Periodic Reports

• Can include any and all case attributes• Graphical User Interface• Can be supplemented with SQL for more complex queries

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Advanced Conditions (cont.)

• Multiple Advanced Conditions (AC) can be combined using Query Sets utilizing SET operators:• UNION• MINUS• INTERSECT

ExampleWant to find all cases that are serious: AC1: ANALYSIS | Case Assessment | Case Seriousness? = YesNow, exclude any cases for female patients: Build a new AC2: PATIENT | Patient Information | Patient Gender = FemaleCombine the two advanced conditions in a Query Set QS1: AC1 MINUS AC2

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Advanced Condition Editor

Comparator to use

Advanced Condition

criteria

Available Case Fields grouped by

tab and section

Current Condition selected

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NDA Periodic( US Only)• Report Configuration• Index of Cases• Index of MedWatch Forms• Line Listing of 15-day Reports• List of nullified 15-day Cases• Tabulation by SOC of submitted Events• Cases sent to FDA under a different NDA• UD Summaries• Summary of Cases missing Assessments• Summary of unlocked Cases• Case Count Summary• MedWatch Forms

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Periodic Reports – NDA: Topics

• Accessing NDA Reports

• Working with the Library

• Running a NDA Report

• NDA Configuration

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Accessing NDA Reports

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NDA Library

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NDA – Running a Report

Run the NDA as “Final” or “Draft”

Provides Progress Update and indicates

which tasks have been completed

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NDA Configuration

Specify if Configuration and/or Page Numbers are to be included

Selected Reporting

DestinationsReport Header

Information (printed on every Page)

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NDA Configuration (cont.)

These Licenses will be included in the Periodic Report

Based on selected ingredients, indications and formulations, the available licenses are displayed

Filte

ring

Opt

ions

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NDA Configuration (cont.)

Date Range & selection Date

Criteria

Flexible additional filtering to only include relevant

cases

Ability to include “missed” cases from a previous reporting

period.

Only look at the primary suspect product

Narrow the set of included cases

(does not affect the section of submitted

forms (Tab 2)

Specify if Current or Data Lock Point

Version is to be used.

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NDA Configuration (cont.)

Specify the starting page number (after the configuration pages)

Includes submissions of NDA licenses not part of the selection criteria of this report

Custom report with layout of tab 2, grouped by initial and follow-up for cases that qualify based on the advanced condition specified(excludes cases of tab3)

ND

A S

ectio

ns to

Incl

ude

Sum

mary R

eports

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NDA Configuration (cont.)

Case Data Analysis, Case Listing or CIOMS II reports included in this section will be based on cases that are

part of the line listing

Case Data Analysis, Case Listing or CIOMS II reports

included in this section will be based on the selection criteria ,

but ignore the date range

The Advanced Conditions specified in these summary tabulations are respected in addition to the NDA inclusion criteria

Checking this will print additional page numbering in

the format: “Sub Report: Page x of y”. The overall

page numbering is continued

Includes a report that lists the case numbers of

cases that are unlocked, but included in this report

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NDA Configuration (cont.)

Allows for an automated way to schedule NDA reports based on a predefined scheduleOptionally, the reports

can be generated x-days after the Data Lock Point

The group responsible for completing the NDA report

This box lists the logic as defined, e.g. every quarter for the first 2 years and then annually until withdrawal of drug

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NDA Configuration (cont.)

Users with “Execute” privilege will only be able to

run a report, but not modify it

Users with “Execute & Modify” privileges will be able to modify the report

as well as execute it

If "Share this report with other users" is not checked, only the user who created this report will be able to use it. The report

will then not be available to other users.

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NDA Configuration (cont.)

The “Templates” tab is for use with Argus Dossier, an additional module

which will not be used during this phase of Argus roll-out) to allow the complete publishing of any periodic

report

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Summary

After completing this course you are now able to:

• Successfully demonstrate all tasks relating to Aggregate Reports• Successfully perform all tasks relating to Periodic Reports

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Thank You

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