Download - Argus Aggregrate Reporting_Katalyst HLS
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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