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Forward/Return product family route

In PV, every company product should belong to a product family. Once a new product family is configured or any changes are made, and products with their licenses are added to the family, a dedicated user has to review and approve all the added information and updates.

Important

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

The review and approval process follows the preconfigured workflow, and the product family status change is achieved via forwarding or returning its route. Every time the route is forwarded or returned, a responsible user receives an email notification inviting them to review the status change in the PV application.

Status change email
Figure 1. Status change email

To forward or return the product family route

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

  2. On the page that opens, from the left pane, select the product family for which you need to forward or return the route.

    Selecting product family
    Figure 2. Selecting product family

  3. On the Product Family form page that opens, from the workspace toolbar, select one of the following options:

    • Forward forward_route_icon.png: to upgrade the product family to the next available status, for instance, from Draft to Ready for Review. This might be done to send the product family record for review or approval.

    • Return return_route_icon.png: to retreat the product family to the previously available status, for instance, from Approved to Draft. This might be done to make the product family record available for edits and reinitialize the review and approval process.

    Forward and Return options
    Figure 3. Forward and Return options

    Tip

    For your convenience, you can also forward and return the route from the product configuration and license configuration pages, and the workflow status is changed for the whole product family.

  4. In the Return or Forward dialog that appears depending on your selection, complete the configurations as explained in the following table.

    Forwarding route
    Figure 4. Forwarding route

    Tip

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

    Element

    Details

    Current Status*

    Represents the current status of the product family.

    The list of statuses, their flow, and their number can be configured per the sponsor's request by the EDETEK administrator.

    Next Status* / Return Status*

    • When forwarding the route, select the next available status for your product family.

    • When returning the route, select the previous available status for your product family.

    Assign to*

    Select the dedicated user who has to review and approve the product family details.

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

    Password

    Enter the password to confirm your action.

    Comment

    Enter the comment to communicate some additional details to the assignee, if needed.

    Workflow History

    Represents the table view of all the previous workflow changes for your product family, who performed them, and when.

    SAVE

    Select save_button_red_white.png to save the implemented changes.

    CANCEL

    Select cancel_button.png to discard the changes without saving.

    Important

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

Once saved, the product family route is forwarded or returned according to the configured workflow. The assigned user can now act on it accordingly.

In this section:

In the pharmaceutical industry, a medicinal product or drug that is being monitored for its safety and efficacy. A product can be a prescription drug, biologic, vaccine, herbal medicine, or any other health-related product that is used to diagnose, treat, prevent, or alleviate medical conditions in humans.

A group of products that share the same key ingredient and data sheets but can have different concentrations of the active ingredient.

sponsor's

An eClinical application that represents an administrative system used to manage users, authorities, and sponsors at the company level. It provides studies, sites, and sponsors with high-granularity role-based access management across all eClinical applications.