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Review trip report queries

A trip report query is a request generated mostly by the data managers (DM) for clarification or fixing of the discrepancies or questionable items noted in the trip report completed in CTMS as a result of the monitoring visit.

In CTMS, you can review the details of all queries related to trip reports of your study in one comprehensive report.

Tip

You can also export the query details if you prefer to work with the data offline.

To review the trip report 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 study management page that opens, from the left pane, select Query Report > Trip Report Queries.

  3. On the Trip Report Queries page that opens, review the details of all trip report queries. The details of all the report columns are explained in the following table.

    Reviewing trip report queries
    Figure 3. Reviewing trip report queries

    Column

    Details

    Site Code

    Represents the code of the site where the data being queried has been collected.

    Monitoring Visit Name

    Represents the name of the monitoring visit at which the trip report query took place.

    Form Name

    Represents the name of the form of the trip report query.

    SN

    Represents the sequence number of the trip report query.

    Question

    Represents the question text on the CRF to which the created trip report query is created.

    Query Topic

    Represents the topic of the created query. The query topic usually explains the reason why the query has been added.

    Creation Role

    Represents the name of the user who created a corresponding trip report.

    Query by

    Represents the user account of the user who created the corresponding trip report query.

    Creation Time

    Represents the time when the trip report query was created.

    Creation Query Age (days)

    Represents the number of days since the query was created.

    Query Age (days)

    Represents the number of days that have passed since the query was assigned to the responsible user.

    Assign to

    Represents whether the query is assigned to Role or Assignee.

    Role

    Represents the role of the user who is responsible for the resolution of the query.

    Assignee

    Represents the user account of the user who is dealing with the trip report raised in the query.

    Query Status

    Represents the current status of the trip report query.

    Overdue

    Represents whether the query is overdue or not.

    Final Reply Text

    Represents the response text of the responsible user of the query.

    Final Reply Time

    Represents the time when the responsible user responded to the query.

    Final Reply by

    Represents the name of the user who responded to the query.

    Closed Time

    Represents the time when the query was closed.

    Closed by

    Represents the user account of the user who closed the query.

You have reviewed the details of the trip report queries in CTMS.

See also
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 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.

An activity in which a monitor, usually a clinical research associate (CRA), visits sites to review and verify study-related activities, including data collection, patient safety, and adherence to the study protocol. The monitor also verifies that the study complies with relevant regulatory requirements and GCP guidelines.