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Review safety query in EDC

A safety query is a communication tool for PV users that facilitates requesting data clarifications, confirmation, fixes, or other assistance from the EDC users who are the reporters of the ICSR in question.

Once you, as a case reporter in EDC, receive a new query from PV, you need to review the request and provide your feedback.

Tip

Once a new query that requires your attention is sent from PV, you receive an email similar to the following.

New query from PV email example
Figure 1. New query from PV email example

To review a safety query in EDC

  1. In the EDC application header, select the SAFETY GATEWAY tab.

  2. On the page that opens, in the left pane, select the Safety Queries subtab.

  3. Under the Open tab of the page that opens, go to the query assigned to you and from the Action column next to it, select Review review_icon.png.

    Selecting query to review
    Figure 2. Selecting query to review

  4. On the page that opens, review and complete the details as explained in the following table.

    Reviewing query
    Figure 3. Reviewing query

    Element

    Details

    General details block

    Represents read-only details of the query

    Case ID

    Represents the unique identifier assigned to the case under the SAFETY GATEWAY > Task List module.

    Type

    Represents the task type under the SAFETY GATEWAY > Task List module.

    Due Date

    Represents the date before which the query must be replied.

    Status

    Represents the current status of the query.

    Site Code

    Represents the site code related to the case occurrence for which the query is created.

    Subject ID

    Represents the ID of a subject for whom the case in question has occurred.

    Suspected Product

    Represents the name of the product that is suspected to have a causal relation to the case in question.

    AE Term

    Represents the event(s) name for which the case report in question has been created.

    Description

    Represents the query topic description provided by the PV user upon creation.

    Safety Query

    Represents a table comprising a list of questions within the query and an option to reply to them.

    Type

    Question Name

    Represents both the data element type to which the question pertains and the question itself.

    PV Form Name

    PV Record Name

    Represents the name of the form within the ICSR for which the query has been created and the name of the record within that form.

    PV Field Name

    PV Field Value

    Represents the name of the field within the form for which the question has been asked and the name of the current value in that field.

    Reply

    Reply Comments

    Represents the reply to the query question if it has been already provided and the comments added to it, if any.

    Reply By

    Reply Time

    Represents the name of the user who provided the reply and the date and time when the reply has been provided in EDC.

    Status

    Reject Comments

    Represents the status of the reply acceptance or rejection on the PV side. If rejected, then displays the reason provided upon rejection.

    Reply

    Select Reply reply_icon.png next to a question and in the Edit dialog that opens, provide your reply and comment, if any, and select save_button_red_white.png.

    Replying query question
    Figure 4. Replying query question

    Depending on the type of question—structured or unstructured—the reply dialog interface varies. For unstructured questions, it is always a free text field, and for a structured question, it depends on the data type of the field to which the question relates.

    For instance, if the question relates to the Verbatim Term field, the reply dialog displays the free text field where you need to enter a verbatim term. And for the Is the case final? field clarification the reply dialog displays the Yes/No option selection.

    Do you like to add additional documents to the reply?

    Provides an option to upload an attendant document to support your replies.

    Select Site Source Document

    Select hierarchy_icon.png and from the Select Site Source Document dialog that opens select the source file pertaining to a specific site. Select save_button_red_white.png to attach the file to your query reply.

    Selecting source document
    Figure 5. Selecting source document

    Upload File

    Select upload_icon.png to upload the attendant file from your computer.

    Document Name

    Represents the name of the attached document, if any.

    Uploaded Date

    Represents the date and time when the document has been uploaded to the system.

    File Size

    Represents the size of the attached file in KB.

    Status

    Represents the file status after the reply is processed in PV—Accepted or Rejected.

    Reject Comments

    Represents the reason provided upon file rejection on the PV side, if any.

    Delete

    Select trash_can_icon.png to remove the file from the attachments.

    Submit

    Select submit_icon.png to send the provided feedback to PV.

Once submitted, the reply is sent to PV. The dedicated recipient—query creator—receives an email notification that their query has a response. The email includes the link to access the system and the specific page that requires attention. To open the needed page, the user must log in to the system upon clicking the link.

In this section:

An eClinical application that is mainly used to collect and manage subject data during clinical trials. It integrates with the Study Designer (SD) application and uses preconfigured there case report forms (CRFs) to complete data collection and management. It also provides an audit trail, data alert, source data verification (SDV), payment management, adjudication, and other functions as well as supports data export according to the CDISC ODM standard.

Get to know all the possibilities of the app with the comprehensive EDC User Guide.

A safety service document that includes information required for reporting the adverse events and problems related to products and complaints filed by consumers with respect to any product.

In PV, an option to add a query question to ICSR and select a specific form, record, and data element that requires clarification. This way, when the EDC user addresses the query from PV and provides updated data, it can be populated directly to the ICSR.

See also: unstructured comment

In PV, an option to add a query question to ICSR without selecting any specific data elements to which it relates. This comment should be addressed by the EDC case reporter, but the system cannot automatically process the answer and implement it in the ICSR forms in PV.

See also: structured question