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Resolve query in visit or form

In EDC, there are two types of queries on which you might work:

  • Manual queries are typically created by data managers (DM) or clinical research associates (CRA) during data review and addressed by clinical research coordinators (CRC) working at sites and having access to original data for checkups. To resolve the manual query, you can either fix the discrepancy or reply to the query topic confirming the data accuracy.

  • System queries are created automatically by the system but still require user interaction to manage and resolve them. For the system queries it is configured by default that the DM role is considered as a creator and only DMs can address and close a system query. To resolve the system query, you need to fix the data discrepancy on which it has been created or reply to the query issue and confirm that the data is indeed correct and does not require fixing.

Tip

If you see Overdue Open Manual Query Overdue_open_manual_query_icon_.png next to a certain query, it means that the query is overdue because the window of days established for resolving it has been exceeded.

Accessing queries in query task
Figure 1. Accessing queries in query task

There are multiple ways to access the queries assigned to you in the EDC system:

  • Access all your queries from the My Queries tile of the My Work dashboard.

  • Access all your queries from the Task module of the Quick panel.

  • Locate a certain query by opening the form page in which the query resides.

  • As a DM, close the system queries in bulk from the System Query Details report page.

This procedure focuses on how to resolve a query by locating it directly in the visit or form to which it belongs.

To resolve a query in a form or visit

  1. In the EDC application header, select the DATA ENTRY tab.

  2. On the site list page that opens, select the tile representing the site with which you want to work.

    Accessing site
    Figure 2. Accessing site

  3. In the Subject ID column, next to the needed subject, select the link representing the subject data to be entered.

    Locating your subject
    Figure 3. Locating your subject

  4. Once the needed subject is accessed, select either of the following two options:

    • In the subject visit tree of the page that opens, expand the needed visit to select the form with the query you intend to work.

      Left panel. Visits and their forms
      Figure 4. Left panel. Visits and their forms

    • On the Subject Visit Overview page, locate the needed visit.

      Locating visit
      Figure 5. Locating visit

  5. Next, access a manual query for the needed visit, form, record, or item as follows.

    Tip

    If you are an assignee of the query, the open query icon displays green My_Open_Manual_Query_icon.png, and if you are not an assignee—the icon appears blue open_query_icon.png.

  6. On the panel that appears, perform one of the following actions:

    1. Answer the query by selecting the My Open Manual Query My_Open_Manual_Query_icon.png or My Open System Querymy_open_system_query_icon.png, as needed. In the Manual Query or System Query panel that opens on the right, enter your reply to the query issue and select Submit red_tic_icon.png.

      Resolving query by answering it
      Figure 10. Resolving query by answering it

      Upon answering the query, it is considered answered and the respective comment is added to the system. The query icon changes to Answered Manual Query answered_manual_query_icon.png or Answered System Query answered_system_query_icon.png, respectively.

    2. Fix the issue of the query by updating the data and submitting the form.

      Resolving queries by updating data
      Figure 11. Resolving queries by updating data

      Tip

      If the form item (field) has an open query assigned to you, upon opening the form such field is enabled for data entry.

      Upon fixing the issue of the query, it is considered closed, and the respective comment is added to the system. The query icon changes to Closed Manual Query closed_manual_query_icon.png or Closed System Query closed_system_query_icon.png, respectively.

You have resolved your query.

In this section:

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 monitoring a clinical trial to ensure it is conducted in compliance with regulatory standards and protocols. The CRA’s scope of work might include protocol review, site selection and initiation, monitoring, data entry control, and more.

In the eClinical system, the Clinical Research Associate (CRA) user role is assigned to a person who works with the sites, and in EDC, mainly has to make sure that the entered data is truthful to the source document. CRA checks the source document in a process called source data verification and ensures that everything entered by the clinical research coordinators is valid to avoid any discrepancies caused by human errors.

A person responsible for the successful planning, execution, and management of clinical trials. The CRC’s scope of work might include study preparation, site setup, patient recruitment, regulatory compliance control, data collection, and more.

In the eClinical system, the Clinical Research Coordinator (CRC) user role is granted to a person who works on a site with subjects and is responsible for entering data to EDC, ensuring the data is entered correctly according to all requirements, and answering queries from data managers on any questionable data pieces.