Summary

This article takes you through the steps to create a query workflow. 

Table of Contents

• Configure Query Workflow
  • Create a Process
  • Create Initial Manual State
  • Set Initial State for the Process
  • Create Additional Manual States
  • Create Query States
  • Add Manual State Transitions
  • Get the processID number
• Data Architect File
  • App Properties
  • Roles
• System
  • Create a Query
  • Review the Query
  • Decline the Query
  • Review a Query’s History
  • View ‘New’ Queries

Query Workflow allows for the automation of the query review and query approval processes. With this feature, queries can be initiated by certain roles and then reviewed by other roles before they become visible to the site. The query workflow is configured within the Enterprise Manager and the Data Architect file. This manual takes you through the steps to create a query workflow.

Configure Query Workflow

Once the workflow tool has been created, query workflow processes can be created. Each process will contain a set of manual states and query states. Manual states refer to the states of the query as it goes through the review and approval process. Query states refer to the possible states of the query after it completes the review and approval process.

Example: A query workflow process called ‘Drug A Query Review’ could have three manual states within the process: ‘Query Created,’ ‘Safety Review Completed’ and ‘Data Management Review Completed.’ Two query states could also be created: ‘Approved Queries’ and ‘Declined Queries.’ The review process would transition from ‘Query Created’ to ‘Safety Review Completed’ to ‘Data Management Review Completed.’ At each of these manual states, the query can leave the workflow process with the query state, ‘Declined Queries,’ or it can complete the workflow process with the query state, ‘Approved Queries.’

The example described above will be used to demonstrate the use of the workflow tool throughout the rest of this manual.

Create a Process

1. On the Desktop, select the newly created tool.
2. On the Manage Processes page, select ‘New Process.’
3. Enter a name for the new process.
   • Example: The review process for a specific drug could be ‘Drug A Query Review’
4. Enter a description for the new process.
   • Example Description: ‘Review queries for Drug A Post Marketing Study’
5. For the ‘Associated Application,’ select the sites that will use this new process.
6. Click the ‘Save’ button.
   • The new process will be added to the process list on the Manage Processes page.

Create Initial Manual State

1. On the Manage Processes page, select ‘View’ for the process that needs new states.
2. On the Manage States page, select ‘Create Manual State.’
3. Enter a name for the manual state.
   • Example name: ‘Query Created.’
4. Enter any text for the Action.

Note: Since this is the initial state, the Action will not be used. The Actions text is only useful for all states besides the initial state.

5. Leave ‘Require Comment’ set to ‘Yes.’

Note: As with the Action, the Require Comment property will not be used for the initial state. Require Comment will be useful for all subsequent states.

6. Select the Individual Owners who should be able to view this manual state.

Note: Depending on how the study is set up, this list might be blank. If so, skip this step.

7. Select the Roles that should be able to view this manual state.
8. Click the ‘Save’ button.

The new manual state will be added to the states list.

Set Initial State for the Process

1. On the Manage States page, select ‘Edit Process.’
2. For Start State, select the name of the initial state.
3. Click the ‘Update’ button.

Create Additional Manual States

1. On the Manage States page, select ‘Create Manual State.’
2. Enter a name for the manual state.
3. Enter a name for the Action.
   • This action corresponds to the action link visible at the site that will transition the query to the next state.
   • Example: To move a query from the Safety Review Completed state to the next state in the workflow, the action could read: ‘Approve Safety Review.’
4. For Require Comment, select ‘Yes’ if a comment should be requested when transitioning the query from one manual state to the next. Select ‘No’ otherwise.
5. For now ignore the ‘Accessible States’ section.
   • Accessible states will be configured when adding the state transitions. It is best to not set accessible states until all manual and query states have been created for the workflow process.
6. Select the Individual Owners who should be able to view this manual state if any are listed.
7. Select the Roles that should be able to view this manual state.
8. Click the ‘Save’ button.
9. Repeat these steps for all additional manual states.

Create Query States

1. On the Manage States page, select ‘Create Query State.’
2. Enter a name for the query state.
   • Example name: ‘Approved Queries’
3. Enter a name for the Action.
   • Example Action name: ‘Approve Query’
4. Specify whether or not comments will be required when transitioning the query from one query state to the next.
5. Select a Query State.
   • This Query State corresponds to the state that will be displayed at the site. For example, if a query is approved, its Query State at the site could be ‘New.’
6. For now ignore the ‘Accessible States’ section.
   • Accessible states will be configured when adding the state transitions. It is best to not set accessible states until all manual and query states have been created for the workflow process.
7. Select the Individual Owners who should be able to view this state if any are listed.
8. Select the Roles that should be able to view this state.
9. Click the ‘Save’ button.
10. Repeat these steps for all additional query states.
    • In the following example two query states have been created: an Approved Queries state and a Declined Queries state.

Add Manual State Transitions

1. On the Manage States page, click the Edit icon for the initial Manual State.
2. In the ‘Accessible States’ section, select the states that this manual state can transition to.
   • Example: The initial state could transition straight to the ‘Declined Queries’ state or it could transition to the next manual state in the process, ‘Safety Review Completed.’
3. Click the ‘Update’ button.
   • The Accessible States will be listed on the Manage States page.
4. Repeat these steps for all additional manual states.
   • In the following example, only the manual states have accessible states. However, query states can also have accessible states. For example, the query state called ‘Declined Queries’ could have ‘Query Created’ as an accessible state in this example. This would allow Declined Queries to be added back into the query workflow if such an action is needed.

Get the processID number

Once the manual states and query states have been configured, the process’s ID must be used on the App Properties worksheet of the Data Architect file to complete the workflow tool configuration process.

1. On the Manage States page, click ‘Manage Processes’.
2. Select the process that was just configured.
   • The system will display a ‘View Process Detail’ form.
3. In the URL, locate the proccessID number

This number needs to be added to the Data Architect file.

Data Architect File

App Properties

1. Name: Enter ‘queryWorkflow’
2. Value: Enter the proccessID number.
3. Name: Optional. Enter ‘shouldRemoveUnviewableQueries’

Note: No Value is required for this property. The Value can be left blank.

Without this property, roles without permission to view queries will see the message, “You do not have permission to view this resource.” With this property, the queries are still hidden, but no message is displayed.

Roles

The states configured for the workflow must also be configured correctly on the Roles worksheet. The Query Statuses at the site, ‘declined’ and ‘unconfirmed,’ need to be viewed by only the proper roles.

1. For each Query Status, enter ‘view’ for the roles that should be able to view it.
   • Example: The Monitor Role was given permission to view the manual states and query states created for the ‘Drug A Review Process.’ In order for the query to transition through the workflow, the Monitor should have ‘view’ permissions for ‘unconfirmed’ and ‘declined’ queries.
2. For the Role Attribute called Created Query Status, enter ‘unconfirmed’ for the roles whose queries should enter the review process.
   • These queries will have an initial state of ‘unconfirmed.’

By making these changes, all created queries will initially only be viewed by the roles given permission to view unconfirmed queries. Then the query can transition through the workflow without being seen by other Roles until it reaches the end of the workflow and is approved to change to the ‘new’ state. Queries that are declined during the query workflow process will also never be viewed by any roles other than the ones given permission to view declined queries.

System

Once the query workflow process has been configured, queries can transition through the process.

Create a Query

1. Click the arrow to the left of the question and select the Queries option.
2. In the resulting Queries window, click the ‘Add’ button to add a query.
3. Enter the query text.
4. Click the ‘Create Query’ button.
   • For Roles able to view unconfirmed queries, the query will appear in the list of queries.

Review the Query

1. On the Desktop, select the query that needs reviewing from the ‘Query Preview’ table.
   • Queries currently in the initial workflow process will be listed.
2. Click ‘Approve Safety Review.’

Note: This text will differ depending on how the workflow process is configured.

3. If a comment is required, enter a comment.
4. Click the button to approve the query.
   • The query has changed states and is ready for the next review process, which can be accessed from the Desktop or from the Workflow Items list on the left of the screen.
5. Click ‘Approve Data Management Review.’

Note: This text will differ depending on how the workflow process is configured.

6. If a comment is required, enter a comment.
7. Click the button to approve the query.
   • In this example the query has now reached the final state. It is ready to be set to the ‘new’ state and sent to the site.
8. Click ‘Approve Query (Send to Site Personnel).’

Note: This text will differ depending on how the workflow process is configured.

9. If a comment is required, enter a comment.
10. Click the button to approve the query.

The query has no more available actions.

Decline the Query

The query can also be declined at any time during the review process.

1. View queries currently in the initial workflow process.
2. Click ‘Decline Query (Site Response Unneeded).’

Note: This text will differ depending on how the workflow process is configured.

3. If a comment is required, enter a comment.
4. Click the button to decline the query.
   • The query has no more available actions.
     
5. At the site, view the Query Manager with a Role that can view declined queries to see this declined query.

Review a Query’s History

At any time during the review process, the query’s history can be viewed.

1. Click the history icon.

The system will display a new window with the query’s event history.

View ‘New’ Queries

In the Query Manager, queries that have been approved for the ‘New’ status will be displayed for Roles permitted to view them.

1. Select a query to view it.

A history of workflow changes will be listed on the Query form.

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