Querying Data

Issuing a Query

Queries are issued by clicking into the item data hyperlink of interest and clicking the ‘add’ button within the queries section of the pop up window. Here, settings can be established to dictate who can view and close the query.

Detailed Description of Query Settings

Here are the main Query Settings described in detail:

• Monitoring Query?  CRA/DM colleagues should keep this box checked to ensure their Query gets visualised in the Completed CRF Report.

• Only opener can close?

  • if you untick this box, anyone that can view the Query, can close the Query.  E.g. a PI that can respond to the Query will be able to immediately close the Query as well.  Generally, it is advised to keep the check box ticked.

  • if you tick “Only opener can close” and do not add a “Close Role Restriction”, only you as the Query creator will be able to close the Query, unless you gave the "Study Query Manage" Role Action to a colleague (see more details below).  In that case he/she will also be able to close your Query.

  • if you tick “Only opener can close” and assign the “Close Role Restriction” to your Role, then you and your colleagues with the same Role will be able to close the Query.

  • if you tick “Only opener can close” and assign the “Close Role Restriction” to another Role than your own, you or anyone with your Role will not be able to close the Query.  Only colleagues with the Role specified in the “Close Role Restriction” will be able to close your Query.

• It is currently NOT RECOMMENDED to use the View Role Restriction;  it will limit what queries you are able to view.

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Editing Query Settings

Settings or attributes related to a query thread can be edited at any point in time by clicking the edit button next to the query thread of interest.

Continuing a Query

Once a query has been issued, it assumes an ‘Unanswered’ state. It is typically the responsibility of the clinic to respond to unanswered queries.

Answering a Query

The authorized user may answer the Query by typing the explanation/clarification into the provided field and clicking “Save”. The Query with an answer will assume “Answered” state.

Closing a Query

Once a query has been answered, it assumes an ‘Answered’ state. It is typically the responsibility of the query issuer to then ask for more information (reverting the query to an ‘Unanswered’ state and therefore placing back in the clinic’s queue) or to acknowledge the response and mark the query as closed.

Useful Dashboard Components

For this process, you may consider using the following Dashboard Components:

• Queries Owned by Me

• Queries I Need to Resolve

• Study Query Overview

• Hidden Items with Open Queries

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Role Actions Relevant to Query Management

Here is a description of Query Management-related Role actions and their impact:

• Study Queries Role Action - to be assigned to any Role that needs to be able to view Queries.

• Study Queries Create Role Action - to be assigned to any Role that needs to be able to create Queries.  When this Role Action is assigned to your Role, you will be able to edit your own Queries.  However, you will NOT be able to edit anyone else's Queries.  Also, with this Role Action assigned you WON'T be able to respond or close your/anyone's Query.

• Study Queries Respond Role Action - to be assigned to any Role that needs to be able to only respond to queries. This would typically be the role of the Study Coordinator/Trial Manager.
  Now, if the Query creator leaves the "Only opener can close" checkbox UNCHECKED, all users with a Role that contains the "Study Queries" Role Action, will be able to close any Query.  It is therefore important of Query creators to ensure that the "Only opener can close" checkbox is CHECKED.
  If the Query creator needs his/her colleagues to be able to close a query on his/her behalf, the "Close Role Restriction" should be set to the role of the Query creator.  

• Study Queries Manage Role Action - to be assigned to any role that needs to be able to always close queries.  This Role Action overrules any setting on the query level. This Role Action is only to be assigned to a coordinator on the site of the query creator team; the person that has this role assigned is able to follow up on any query in case of holidays/absence/... of the original query creator.