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.</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.</p> Signup and view all the answers

    What is the update regarding the Reporter Type section?

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

    Which product information fields were updated in the Product Tab?

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

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

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

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

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

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

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

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

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

    Which option is NOT mentioned under the Regulatory Reports Tab?

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

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

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

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

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

    Which field was removed from the Medical Review section?

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

    What new information was added under the Patient tab?

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

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

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

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

    <p>Code</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</p> Signup and view all the answers

    What significant change occurred regarding the classification for reimbursement programs?

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

    Which sub-tab was introduced to the Products tab?

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

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

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

    What type of field was added to the Products Tab?

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

    Which tab has the update regarding the Date of Death?

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

    Which of the following was NOT mentioned as being updated?

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

    In which tab were new letter templates added?

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

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

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

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

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

    Which field saw updates specifically related to source justifications?

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

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

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

    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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    Related Documents

    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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