Skip to main content

Query summary

In the Study Analytics dashboard, you are provided with multiple charts to get a quick insight into the current state of the EDC data and processes going on. The Query Summary bar chart is one of such charts displayed in the dashboard that captures all the system and manual queries that are opened, answered, and closed.

The system queries are automatically generated by the system when an eCRF has wrong or missing information. On the contrary, manual queries can be generated by a system user on any specific data item of a form (eCRF) on which they require assistance from a colleague (data manager (DM), principal investigator (PI), or others).

For example, while recording the adverse events of a subject, if Death is selected for the Serious Criteria field, but in the Outcome field, Death Related to Adverse Event is not selected, then upon saving the form (eCRF), the system generates the following query: Death should be checked when Outcome is Death Related to Adverse Event, or Death should not be checked when Outcome is not Death Related to Adverse Event. Please correct to clarify.

Similarly, while adding the adverse events records, you can generate a manual query for the DM to review the form or add information in a specific data field of a form.

This bar chart is updated in real-time, that is as soon as a query is generated (manual or system) or is answered, closed, and so on, then the count of the respective bar is updated in the chart.

Query summary bar chart
Figure 1. Query summary bar chart

See also
In this section:

An electronic version of a CRF that is a specialized document in a clinical trial designed to collect subject's data.

A person responsible for managing and ensuring the integrity, accuracy, and confidentiality of data collected during clinical trials. The DM’s scope of work might include maintaining the quality of data, complying with regulatory requirements, and supporting the overall success of clinical research.

In the eClinical system, the Data Manager (DM) user role is granted to a person who is mainly responsible for cleaning the data, making sure the data is entered correctly according to all requirements and industry standards, and creating manual queries for clinical research coordinators on any questionable data pieces. Before the study goes live, works with the sponsor and receives and addresses their feedback to set up the study and CRFs in EDC in a way that the sponsor approves.

A person responsible for overseeing and conducting the research study at a specific investigational site or multiple sites, depending on the study's design. The role of a PI is multifaceted and involves various responsibilities, such as study oversight, protocol adherence, participant recruitment and informed consent implementation, regulatory compliance, and so on.

In the eClinical system, the Principal Investigator (PI) role that is assigned to a person who oversees the data entering and signs off subjects—gives authorized confirmation that all the entered data is valid and follows the industry standards. The responsibilities of PI can vary depending on study requirements.