MedWatch and CIOMS Forms Quiz
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Questions and Answers

What is indicated if a field value will not display on a MedWatch or CIOMS form?

  • It is marked as 'No Mapping'. (correct)
  • The field is mandatory.
  • The field value is incorrectly configured.
  • It requires additional input from the user.

What does the E2B Mapping section provide information about?

  • The number of characters allowed in the field.
  • Whether the value will be transmitted via E2B. (correct)
  • Field value instructions for entry.
  • Details of countries affected by the value.

What role does the author D. Petrazzuoli have?

  • Business Consultant / Safety Data Management (correct)
  • Document Reviewer
  • Data Entry Specialist
  • Safety Data Analyst

What does the meaning of the signature by reviewers signify?

<p>They have read and agree with the details relevant to their expertise. (C)</p> Signup and view all the answers

What information can be expected in the 'Additional Comments' section?

<p>Extra explanations for field usage or data entry. (C)</p> Signup and view all the answers

What is the update regarding the Reporter Type section?

<p>It has been corrected to just 'Other'. (C)</p> Signup and view all the answers

Which update pertains to the Lab Data section in the Patient Tab?

<p>It was updated to include verbatim test name and notes. (D)</p> Signup and view all the answers

What requirement was clarified in the Protect Confidentiality section?

<p>The instructions and help field were corrected and clarified. (B)</p> Signup and view all the answers

What is a newly added feature in the Product Tab regarding device handling?

<p>Multiple fields updated to reflect data entry requirements. (D)</p> Signup and view all the answers

What must be done if a product is not available in the CDD dictionary?

<p>A request must be sent to have the product added. (A)</p> Signup and view all the answers

Which product information fields were updated in the Product Tab?

<p>Model#, Serial#, and Product name. (B)</p> Signup and view all the answers

What significant change occurred in the Age section of the Patient Tab?

<p>The instructions field was updated. (D)</p> Signup and view all the answers

Which of the following sections had updates to their instructions fields?

<p>Both the Patient and Product Tabs. (A)</p> Signup and view all the answers

Which tab includes the field 'Company Comment (German Language)'?

<p>Medical Review Tab (B)</p> Signup and view all the answers

Which instruction is related to the 'Submissions Tab' in the Regulatory Reports Tab?

<p>Submission required (C)</p> Signup and view all the answers

What did the revision dated 22-Jun-2018 remove from the Additional References?

<p>Case splitting instructions (D)</p> Signup and view all the answers

What is newly added for COI Switzerland under the Narrative Templates-Statement?

<p>Company Comment (A)</p> Signup and view all the answers

Which option is NOT mentioned under the Regulatory Reports Tab?

<p>Update Field Values (A)</p> Signup and view all the answers

Which element is included in the Narrative Templates-Statement section?

<p>Local Swiss Label Assessment (C)</p> Signup and view all the answers

Under which tab can you find instructions similar to 'Remove Report'?

<p>Regulatory Reports Tab (B)</p> Signup and view all the answers

What type of information is associated with the 'Update: Instructions' in various tabs?

<p>Guidelines for data entry (A)</p> Signup and view all the answers

What type of updates were made to the Phone field in the MedWatch Information subtab?

<p>Field type update (D)</p> Signup and view all the answers

Which subtab in the Analysis tab received a new 'Add and Remove' button?

<p>Event Problem Codes Information (D)</p> Signup and view all the answers

Which field was removed from the Medical Review section?

<p>Company Diagnosis/Syndrome (B)</p> Signup and view all the answers

What new information was added under the Patient tab?

<p>All of the above (D)</p> Signup and view all the answers

What kind of update was made to the Report Sent to MFR field?

<p>Field type update (C)</p> Signup and view all the answers

Which of the following options describes a new field added in the Activity tab?

<p>Code (B)</p> Signup and view all the answers

What was the nature of the update to the Location where the event occurred?

<p>New field values added (A)</p> Signup and view all the answers

What significant change occurred regarding the classification for reimbursement programs?

<p>Comment added (B)</p> Signup and view all the answers

Which sub-tab was introduced to the Products tab?

<p>PMDA Device Information (C)</p> Signup and view all the answers

Which of the following fields in the Patient tab received an update with additional comments?

<p>All of the above (D)</p> Signup and view all the answers

What should be done if the country of the incident is unknown in literature cases?

<p>Use the country of the primary author (B)</p> Signup and view all the answers

In the context of Japan Foreign Safety Measures Report, what should be done if the same measure was implemented in multiple countries?

<p>Enter additional countries and keep the original COI (B)</p> Signup and view all the answers

What information should be entered for Japan Research Report?

<p>The COI related to the organization of the reporter (B)</p> Signup and view all the answers

What action should be taken after selecting a study in the CT report type?

<p>Auto-populate relevant information (D)</p> Signup and view all the answers

What should be done when entering product information in a PM report type?

<p>Enter detailed product specifications (B)</p> Signup and view all the answers

What is necessary to select an appropriate Report Type?

<p>Type the first letter of the report type (B)</p> Signup and view all the answers

What should occur after typing a country code in the context described?

<p>Click the Tab key (D)</p> Signup and view all the answers

What is the recommended approach when dealing with spontaneous literature for safety report types?

<p>Select the report type from a drop-down menu (B)</p> Signup and view all the answers

What type of field was added to the Products Tab?

<p>Patient Problem Code (B)</p> Signup and view all the answers

Which tab has the update regarding the Date of Death?

<p>Events Tab (B)</p> Signup and view all the answers

What was the nature of the update for the 'Expected Date of Follow-Up' field?

<p>Instructions field updated (B)</p> Signup and view all the answers

Which of the following was NOT mentioned as being updated?

<p>Search Tab (B)</p> Signup and view all the answers

In which tab were new letter templates added?

<p>Activities Tab (B)</p> Signup and view all the answers

What was updated in the 'As Determined Listedness' field in the Medical Review Tab?

<p>Instructions and Additional Comments updated (A)</p> Signup and view all the answers

What type of updates were made regarding the 'Country of Incidence' field?

<p>Additional Comments updated (A)</p> Signup and view all the answers

Which field was mentioned to have additional comment updates that indicates a modification?

<p>Event Receipt Date (D)</p> Signup and view all the answers

Which field saw updates specifically related to source justifications?

<p>Follow-up Source Justification (D)</p> Signup and view all the answers

What update was made to the Regulatory Reports Tab regarding General Headings?

<p>General table headings updated (C)</p> Signup and view all the answers

Flashcards

Safety Data Management Guide

A document that outlines the procedures and standards for data management within a company, particularly for safety and pharmacovigilance.

Reviewer

A person responsible for reviewing and approving a document, ensuring its accuracy and completeness.

Document Review

The process of ensuring that a document meets the required standards and is fit for its intended purpose.

Document

A structured document prepared for a specific purpose, often with defined content sections and an approval process.

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Doc.No.

A designated number or code used to uniquely identify a document within a system.

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Lab Data

Provides detailed information about laboratory tests performed on the patient, including test name and notes.

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Protect Confidentiality

This section ensures patient privacy by outlining instructions and providing help with data confidentiality.

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Age

A field used to record the patient's age, with clear instructions for data input.

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Gender

A field used to record the patient's gender, with clear instructions for data input.

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Suspect / Concomitant / Treatment

This section details information about products suspected to be involved in the adverse event, including any concomitant medications or treatments.

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Device Sub-Tab

A specific tab within the Product tab that gathers detailed information related to medical devices involved in the adverse event.

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Action Taken

A field where actions taken in response to the adverse event are documented, with clear instructions for data input.

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Serial#

A field that ensures accurate identification of medical devices by recording their unique serial number in the report.

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Argus DEC V12.0 Guide

A guide for using the Argus DEC software, specifically for Version 12.0, which includes procedures and instructions for data management.

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Summary of Revisions

A comprehensive overview of the changes made in a document, typically providing information like the date of update, fields modified, and the responsible party.

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Initial Source Justification

The initial source of information that triggers a report or investigation into a potential adverse event.

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Country of Incidence

The country where an adverse event occurred.

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Pat ID

The patient's unique identifier within the system, used to track their information.

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Age Group

A classification of the patient's age, typically categorized into groups like infant, child, adult, or elderly.

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Weight

The patient's measured weight, often recorded in kilograms or pounds.

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Height

The patient's measured height, often recorded in meters, centimeters, or feet and inches.

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Additional Comments

A field within the Argus DEC system where additional comments or details can be added to provide context or further explanation.

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Attach File

In the 'Additional Info' tab, this field allows the user to attach relevant files to the case.

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References (Type)

This field in the 'Additional Info' tab provides options like Literature Cases, Post Marketing, and Clinical Trials. It's used to categorize references.

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Destination

In the 'Regulatory Reports' tab, this field indicates the intended recipient of the report.

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Responsible

The 'Regulatory Reports' tab allows you to specify who is ultimately responsible for a particular report.

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Remove Report

The 'Regulatory Reports' tab enables the user to remove a regulatory report from the case.

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Routing Tab/ Date Time

The 'Regulatory Reports' tab allows users to track the route and time a report takes to be finalized.

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Routing Tab/ User

The 'Regulatory Reports' tab allows you to see who has reviewed a report.

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Submissions Tab/ Submission Required

This option in the 'Submissions' tab of the 'Regulatory Reports' tab indicates whether a report is required for the current case.

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Updated MedWatch Information Fields

The 'MedWatch Information' subtab in the 'Analysis' tab has been updated with additional fields for User Facility or Importer Name and Contact Person, as well as a new field for Phone. The 'Date aware' field has also been updated to a different data type.

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Multiple Event Locations

A new field for reporting the 'Location where event occurred' has been added to the 'Analysis' tab, along with a new field for 'Other location where event occurred'. This allows additional locations to be recorded in the report.

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Flexible Problem Codes

The 'Event Problem Codes Information' field in the 'Analysis' tab now includes an 'Add and Remove' button, enabling users to add and remove relevant problem codes as needed.

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Expanded Contact Code Options

The 'Code' field in the 'Contact Log' subtab of the 'Activity' tab has been updated to include new field values, meaning more options are now available when recording contact details.

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Custom Letter Flexibility

The 'Custom letter' field in the 'Activity' tab accommodates new field values, allowing for a wider range of custom letter options to be used.

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Archived By Renamed

The 'Locked or Archived By' field in the 'Activity' tab has been renamed, signifying a change in the field's purpose or labeling.

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Urgent Reporting Option

A new field for 'Urgent report' has been introduced in the 'Regulatory Reports Tab', allowing users to specifically mark a report as urgent when needed.

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Updated Term Type Options

The 'Initial Case Entry & Dup Search' tab has revised its 'Term Type' dropdown options, enabling users to select from a wider range of term types.

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Clarified Message Type

The 'Incoming ICSR Reports' tab has added a comment to the 'Message Type' field, providing context or further clarification related to its purpose and input.

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Reimbursement Program Note

The 'Classification' field in the 'General tab' has been updated with a comment related to reimbursement programs, providing additional information about how classifications impact reimbursement processes.

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J.10

When a report involves multiple countries, this field shows the additional countries where the measure was published; however, the original Country of Incident (COI) remains unchanged.

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Country of Incident (COI)

For Literature cases, if the country of incident is unknown, use the country of the Primary Author.

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Spontaneous Literature

Select this report type for literature containing safety information that doesn’t relate to a clinical trial.

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Country of Incident (COI) for Japan Research Reports

For Japan Research Reports: This field shows the location of the organization the reporter/author belonged to or the location of the trial site.

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Study Selection

Used to select a specific study within a Clinical Trial (CT) report. Selecting a study automatically populates relevant information.

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Auto-populated information

When a study is selected in a CT report, all relevant information is filled in automatically.

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Product information

For PM (Product) reports, the field requires the entry of product information.

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Filter and select

Type the first letter of the option to filter the list and select the appropriate option. Then, press the Tab key to confirm the selection.

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Study Notes

Approval Document

  • Document title: AVISSO_v8.2_DEC
  • Document number: GSD-GLB-COMP-2022-0045-00027.001
  • Approval date: October 18, 2023 (11:20:43 AM EDT)
  • Approver: Nipa Parikh ([email protected])
  • Approver: Vikalp Khare ([email protected])
  • Action: Approval

Otsuka Data Entry Convention (DEC)

  • Version: 12.0
  • Effective date: October 30, 2023
  • System: Oracle Argus Safety Database

Overview (Argus DEC V12.0 Guide)

  • Document purpose: Guideline for entering data into Oracle Argus Safety System interface fields.
  • Document summary: Presents data entry guidelines for each tab/screen in the Argus Safety System, organized by tab and section.
  • Information presented for each field: Field name, field type, field values, instructions, MedWatch and CIOMS mapping, E2B mapping, and additional comments.

Revision History (Argus DEC V12.0 Guide)

  • Multiple revisions documented, with dates, authors, and descriptions of changes
  • Examples of different authors and review dates
  • Example of a revision from a specific date and author

Initial Case Entry & Dup Search (Argus DEC V12.0 Guide)

  • The document details Case Search Criteria and Action Buttons for finding potentially duplicate cases
  • Instructions are given on various data fields

Incoming ICSR Reports (Argus DEC V12.0 Guide)

  • Document gives instructions and data fields for ICSR reporting
  • Lists possible search criteria and how to set a reporting destination

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Otsuka Data Entry Convention (DEC) Version 12.0 PDF

Description

Test your knowledge about the updates and requirements for MedWatch and CIOMS forms. This quiz covers various sections including the Lab Data section, Product Tab updates, and confidentiality requirements. Assess your understanding of the important functionalities and features within these reporting forms.

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