Skip to main content

Resolve assigned queries

In CTMS, a query is a clarification or assistance request created by the user or the system to address data discrepancies or other findings in trip reports, protocol deviation records, or ICF tracking log records.

If you are responsible for handling queries in CTMS, you have respective tasks assigned to you in the system. For your convenience, all the tasks pertinent to a certain study, including queries awaiting resolution, are comprised under a single interactive dashboard called My Work.

To resolve the assigned queries

  1. Access the study management page in one of the following ways:

    • In the CTMS application header, select the DASHBOARD tab and then select the study dashboard of your interest.

      Accessing study management from dashboard
      Figure 1. Accessing study management from dashboard

    • In the CTMS application header, select the STUDY MANAGEMENT tab. Then from the Study Data List table, select the study name of your interest.

      Accessing study management from study data list
      Figure 2. Accessing study management from study data list

  2. On the My Work page that opens, select the Queries task category tile.

    Selecting queries tile
    Figure 3. Selecting queries tile

    Important

    Note that the task categories you see may differ depending on your user role and the set of tasks assigned to you in the system according to your field of responsibilities and company arrangements.

  3. In the table that appears, all the queries assigned to you are displayed. Locate the query on which you want to work and select its Query Topic value.

    Selecting query to work on
    Figure 4. Selecting query to work on

    Tip

    To facilitate your search, do the following:

    • Select the number next to the query type—Trip Report Queries, PD Queries, or ICF Tracking Log Queries—to filter the table appropriately.

    • Once filtered by Trip Report Queries, PD Queries, or ICF Tracking Log Queries, select the number next to the needed query status—My Overdeu Open Query my_overdue_open_query_icon.png, My Overdue Answered Query my_overdue_answered_query_icon.png, My Open Query my_open_query_icon.png, or My Answered Query my_answered_query_icon_green.png.

    • Select filter_icon_red.png to clear filters and return to the unfiltered query list.

    Filtering queries
    Figure 5. Filtering queries

You have accessed the trip report query resolution, PD record query resolution, or ICF record query resolution page.

Working on queries
Figure 6. Working on queries

Tip

Use the Queries table to navigate between queries without returning to the My Work dashboard. Otherwise, select Back to My Work to return to your other task categories.

You can also use refresh refresh_icon.png to see the latest queries or collapse collapse_icon.png or close x_icon.png the table if not needed.

In this section:

A document that summarizes the activities, observations, and findings of a monitoring visit conducted by a clinical research associate (CRA) or a monitor at a clinical trial site. The purpose of a trip report is to provide a detailed account of the visit, including the review of study data, source documents, regulatory compliance, and overall study conduct.

A divergence from the IRB or sponsor-approved study design or procedures defined in the protocol, consent document, or study materials. The deviation can occur due to multiple reasons, such as a subject missing their visit, enrolling a participant who did not meet all the inclusion criteria, failing to perform a required lab test, and so on.

A document used to track the distribution, collection, and status of Informed Consent Forms (ICFs) from participants in the trial. It is a management tool that ensures proper documentation and completion of all steps related to informed consent throughout the trial process.