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Return ICSR workflow route

The Return Route feature enables the return of ICSRs from their current workflow status to the previous one. Once the route is returned, the ICSR inherits a new user-defined status that has been configured during the workflow design.

Important

The workflow of the ICSR review and approval process can be customarily configured by the EDETEK administrator according to the client's requirements.

Some workflow stages might include system validation to prevent ICSRs from being forwarded to the next stage without completing all the activities or meeting the requirements of the previous one.

To return an ICSR workflow route

  1. In the PV application header, select the ICSR tab.

  2. From the left pane, select ICSR List.

    Accessing ICSR list
    Figure 1. Accessing ICSR list

  3. On the ICSR List page that opens, in the table, locate the ICSR record for which you need to return a route. Then select its case number to open the details page in the new browser tab.

    Alternatively, from the Actions column next to your ICSR, select Edit pencil_icon.png to open the ICSR details in the same browser tab.

    Selecting to edit ICSR
    Figure 2. Selecting to edit ICSR

  4. On the page that opens, from the toolbar, select Return return_icon.png.

  5. In the Return dialog that appears, fill in the fields as suggested in the following table.

    Returning route
    Figure 3. Returning route

    Tip

    In the following table, mandatory elements are marked with an asterisk (*).

    Element

    Details

    Current Status*

    This field is disabled by default and it represents the current workflow status of the ICSR.

    Return Status*

    Select the return workflow status for the selected ICSR.

    Assign to*

    Assign a user who needs to review the workflow status change and take corresponding actions.

    The list of assignees is based on their study access permission granted via ADMIN.

    Comment*

    Add a comment for the committed operation.

    Username or Email*

    Enter your username or email for which the eClinical system access is configured.

    This field is only available if, for your ICSR workflow stage, it is configured to request user credentials for confirmation. If the workflow stage to which you return the route does not require confirmation, this field disappears from the form.

    Send Code

    Select send_code_button.png to send the temporary PIN code to your email for which the SSO method is configured.

    The PIN code is valid for 5 minutes before it expires. Select The PIN code is valid for 5 minutes before it expires. Select send_code_button.png again to send another email and regenerate the PIN if required.

    The button is only available if you use the authorization method via SSO and if, for your ICSR workflow stage, it is configured to request user credentials for confirmation. If the workflow stage to which you return the route does not require confirmation, this option disappears from the form.

    Code*

    Enter the temporary PIN code that you received via email.

    This field is only available if you use the authorization method via SSO and if, for your ICSR workflow stage, it is configured to request user credentials for confirmation. If the workflow stage to which you return the route does not require confirmation, this option disappears from the form.

    Example of field for entering code
    Figure 4. Example of field for entering code

    Password

    Enter your user password to confirm the action.

    The field is only available if you use the authorization method by providing your login and password and if, for your ICSR workflow stage, it is configured to request user credentials for confirmation. If the workflow stage to which you return the route does not require confirmation, this option disappears from the form.

    Example of field for entering password
    Figure 5. Example of field for entering password

    Workflow History

    Use the table data to analyze all the previous workflow route changes for the case, including the details on what was done, by whom, when, and so on.

    SAVE

    Select save_button_red_white.png to apply the workflow status return.

    CANCEL

    Select cancel_button.png to cancel the workflow status return.

    Important

    For security, the system logs you out after three failed attempts to confirm your identity with a password or code.

  6. In the Validation dialog that may appear, view the generated field-, record-, and configuration-level workflow validation errors if any.

    Receiving validation errors
    Figure 6. Receiving validation errors

    Important

    The Validation dialog may not appear if no validation rules have been configured for a specific workflow route.

  7. Select Locate locate_icon.png next to the needed validation error to go to its location within the case. Resolve all validation errors that you can navigate between from the interactive panel of the case.

    Navigating validation error panel
    Figure 7. Navigating validation error panel

  8. After resolving the validation errors, repeat steps 1-5 of this procedure to return your case to the needed route.

Once the action is confirmed with no validation errors, the route is returned. The assignee receives an email notification including the link for the user to easily 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.

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