Summary

This article covers transition statuses and workflows that need completed in the deviation approvals section that allow users to configure the transition statuses and determine their logical order.

Table of Contents

When a deviation occurs, it must go through a review process. Different studies require different review processes, so users have the option to create workflows to meet their needs. Workflows are comprised of Transitions Statuses, customized by the user. The Deviation Approvals section allows users to configure the transition statuses and determine their logical order, thus creating the workflow. Deviation Approvals have 2 sections to complete:

  • Transition Statuses
  • Workflows


Transition Statuses

The Transition Statuses allows users the ability to define the steps that will be used in the workflow. Transition statuses must be defined before adding a workflow.

Add Transition Status

  1. To add a new transition status select “Add Transition Status” from the Actions menu.
  2. The Add Transition Status dialog displays with the Status Name field.

  4. The Status Name field will be the label used for the workflow step.
  5. The Save button will save a new status to be used in the workflow.

 

 

Edit Transition Status

  1. To edit an existing transition status, select the Edit icon for the status name.
  2. The Edit Transition dialog displays with the existing status name populated in the Status Name field.
  3. Update the Status Name field and select Save to update the label of the status.

 

Delete Transition Status

A status that is used in a workflow cannot be deleted. The Delete icon will not be available.


To delete a status that has not been included in a workflow:

  1. Select the Delete icon for the status to delete.
  2. A confirmation screen will appear to confirm you wish to delete the status.
  3. Select Save to confirm and delete the status.
  4. Select Cancel to keep the status.

 

Workflows

Workflows allow users the ability to define the workflow steps that a deviation will go through during review and finalization.

Creating a workflow it is a two-step process; the workflow needs to be created and then define the transition steps in the workflow.

 

Add Workflow

  1. To add a new workflow select “Add Workflow” from the Actions menu.
  2. The Add Deviation Workflow screen will appear.
  3. The Workflow Name field will be the label used to identify the workflow. This will be the name displayed at the study level when selecting the Deviation Workflow for the study on the Study Form.
  4. The Initial Status field will be the Transition Status that a new deviation will set to when first created.
  5. The Submitted Status field is used to identify the workflow status that represents work being completed. It is to facilitate the measurement of time between a “Submitted” status to a “Finalized” status.
  6. The Final Status field is used to identify the workflow status that represents the approval of the work or completion of the process. It is to facilitate the end piece of the measurement of time between a “Submitted” status to a “Finalized” status. These fields are reported on in the Deviations Manager and the Study Deviations table.

The Save button will save the Workflow Name and Initial Status and the Deviation Transitions screen appears with the new Workflow in the Workflow table.

 

 

Add Workflow Transitions

  1. Select the Edit icon for the workflow to define the transition steps for the workflow.
  2. The Edit Deviation Workflow screen will appear.
  3. Select Add Transition from the Actions menu.
  4. The Add Transition dialog will appear.
  5. The From Status field is for the current status.
  6. The To Status field is the next logical status to which the deviation can be transitioned.
  7. The eSignature Required field is to determine if the user who is transitioning the deviation is required to enter their password to process the transition.
    • Yes: eSignature is required on the transition.
    • No: eSignature is not required on the transition.
  8. The Lock Report field is to determine if after the deviation is transitioned from the From Status to the To Status, the Edit icon will be available for edits to occur while in the “To” status. It is common for users to prefer that edits are not able to be made while in a review or approved status. The deviation can always be transitioned back to a status that allows editing, if a transition designed as such is included in the workflow.
    • Yes: The deviation is locked.
    • No: The deviation is not locked and can continue to be edited.
  9. The Roles Allowed to Transition is a multi-dropdown field to define which roles are allowed to make the transition in the workflow. The user must have the role to see the Transition icon on the Study Deviation Table.
  10. Select Save to save the transition step and the user is taken to the Edit Deviation Workflow.

Complex Workflows can be created by defining multiple To statuses for each From status step based on client’s needs. An example of a multi-step transition is:


Edit a Transition Step

  1. Select the Edit icon for the transition step.
  2. The Edit Transition Dialog will appear.
  3. Update the fields that need to be edited.
  4. Select Save to save the changes.
  5. Select Cancel to cancel the changes.

 

Delete Transition Step

To delete a transition step in a workflow:

  1. Select the Delete icon for the transition to delete.
  2. A confirmation screen will appear to confirm you wish to delete the transition.
  3. Select Delete to confirm and delete the transition.
  4. Select Cancel to not delete the transition.

 

Delete Workflows

To delete a workflow:

  1. Select the Delete icon for the workflow to delete.
  2. A confirmation screen will appear to confirm you wish to delete the workflow.
  3. Select Delete to confirm and delete the workflow.
  4. Select Cancel to not delete the workflow.

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