Enhancements to query management

Sponsor users can now allow different roles to review, comment, and manage assigned queries. Additionally, you can now filter queries by visit when managing queries in the Query List page.

Reassigning queries with comments to other sponsor study roles allows for better management during the review process of a query. Additionally, changes in the User Interface (UI) now support query reassignment and other enhanced workflows in query management.

Before you work with this feature

Data managers and other users with permissions associated with query management can manage all queries from the Query List page. The queries you see and the allowed actions depend on your specific permissions. Refer to Sponsor and Site permissions - Study Management.

Sponsor users can assign queries that need to be answered, to user roles with the permissions to view and answer these queries. These include:
  • View All Queries
  • Answer Assigned Queries
Sponsor users can assign answered queries to user roles with the permissions to close queries (depending on the query type). These include:
  • Close Auto-Queries
  • Closed Queries Opened by my Role
  • Close All Queries

More information can be found in the Add Users Guide after the assessment environment upgrade completes.

About reassigning queries

Sponsor users can now reassign queries to different study-roles, either to request the other study role user to answer it, or to review the answer and close it. You can do this from the Actions drop-down in the Query List, from the Query Details page, and directly within the form.

When you choose to reassign a query, the Re-Assign Query dialog prompts you to select a role and provide a comment for the new assignee. The Comment field is mandatory when reassigning queries with a status of Answered, and optional when queries have a status of Open. The newly assigned role is then included in the query's history, and associated to the comment.

Query assignment also changes upon answering and re-opening queries:
  • Answered queries get assigned back to the user role who opened the query.

    Note:

    Queries that were raised automatically (auto-queries) get assigned to System when answered.
  • Re-opened queries are assigned back to the role that answered the query most recently by default, but you can re-assign the query to a different role before completing the re-opening process.

UI changes for query management workflows

As a sponsor or site user working with queries, you can see the following changes in the User Interface (UI) introduced to facilitate your workflow:
  • The To Do view within the Query List is now filtered to show only queries that are assigned to your user role and require any action. These can be either answered or opened queries. Any other unresolved queries display in the Unresolved Queries view.

    Note:

    • Sponsor users with the Answer Queries permission also see all the opened Site queries in the To Do list.
    • Answered auto-queries assigned to System are visible to all users under the Unresolved Queries tab.
  • To help you visualize query assignment, the new column Assigned User Roles appears for queries listed under all views: To Do, Unresolved Queries, and Closed.
    • For an Assigned query, this column shows the user role(s) it is assigned to.
    • For Site queries, this column defaults to Site.
    • For answered Oracle Central Coding queries, this column defaults to Central Coding.
  • A new filtering option for visits is now available in the Query List page, populated with all visits that ever existed in the current mode. Select a specific visit or visits to view all queries added on those given visits.
    • You can use this filter alone or in combination with others, and in the case of cumulative filter selections, you will be notified if there are no results meeting the filter criteria.
    • The list of forms available from the form filter gets populated dynamically, based on visit selection., showing only the forms relevant to the selected visits. If no visit is selected, all forms with queries on your list are available for selection.
  • The View in Form option is now available from the Actions drop-down, allowing you to navigate directly from the Query List to the source form and visit.

You can find more information in the Sponsor and CRO User Guide and the Site User Guide after the assessment environment upgrade completes.

Already working in a live study?

The re-assignment functionality applies only to assigned queries created after the production upgrade completes. Once the production upgrade completes, newly created queries can be assigned to different user roles and have comments added to them.

Additionally, the query reassignment information flows normally through Oracle Clinical One Analytics, with no structural changes in the Oracle Clinical One Analytics datasets to reflect it.

Parent topic: Data review