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Work on assigned monitoring visit tasks

When managing a study in CTMS, you can access all your tasks from a single interactive dashboard called My Work. This dashboard features all your tasks conveniently categorized by tiles.

One of the tiles represents the tasks related to monitoring visits management. Using this dashboard functionality, such users as data managers, principal investigators, or else can directly access all the monitoring visits that require their approval, as well as trip reports awaiting submission or audit.

To work on the assigned monitoring visit tasks

  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 Monitoring Visits task category tile.

    Selecting monitoring visit tasks
    Figure 3. Selecting monitoring visit tasks

    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, the tasks of all types are displayed—Monitoring Visit Approval, Trip Report Submission, and Trip Report Approval. Optionally, select the number next to the task type of your interest to filter the table appropriately and facilitate your search.

    Selecting monitoring visit task type
    Figure 4. Selecting monitoring visit task type

    Tip

    Select filter_icon_red.png to collapse the filter panel and return to the unfiltered task list.

  4. Locate the task on which you want to work and select its monitoring visit name:

    Selecting monitoring task to work on
    Figure 5. Selecting monitoring task to work on

You have now accessed the needed work area—monitoring visits approval or trip report submission and auditing form.

Working on monitoring visit task
Figure 6. Working on monitoring visit task

Tip

Use the Monitoring Visits table to navigate between monitoring visit tasks 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 tasks or collapse collapse_icon.png or close x_icon.png the table if not needed.

In this section:

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.

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.

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.