Clinical Studio incorporates an advanced Query Management System that is fully integrated. The QMS creates both manual and automatic queries and deploys those queries to the appropriate role at the appropriate site. All edit checks that fire automatically create a query and that query is deployed to the data coordinator at the site in question. The data coordinator can then either fix the data in question or add to the query dialog documenting why the edit check cannot be resolved by changing the data. The data coordinator can then choose to declare a protocol deviation and close the query, force the query closed or continue the dialog to gain a greater understanding of the issue. The system allows you to configure the reasons for closing queries. In any event, the entire process is documented and reported on. All new queries and messages are published in the user’s Notification app.
Automated queries are produced on edit check errors, missing visits, visits outside scheduled window, forms saved as draft and missing reason for data change.
If a user is given the right, they can leave a manual query. When a data manager is reviewing data, they can leave a query for the site. Or they can deploy that query to another data manager or both. Once that query is opened, it must be resolved by the creator of the query.
All queries, both open and closed, are available in the Notifications app. The Notifications app allows any user to view their queries, drill into the subject, form or field in question and filter by query type, status, date or entity. By having no open queries, a site user is completely caught up on their work. The QMS makes site training a snap as any issues or missing work are reported as query notifications.
QMS is one of many clinical trial management features found in Clinical Studio.