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Analyze study quality control statistics

The Study Quality Control dashboard comprises statistics on various monitoring activities for your study.

Monitoring refers to the process of inspecting and managing clinical trial activities. Using the CTMS system, clinical research associates (CRA) can manage and control various aspects of the trial to ensure the quality and timeliness of all activities and avoid potential risks. During monitoring, some findings might show protocol deviations of various severity. The process of monitoring and handling protocol deviations is depicted in the Study Quality Control dashboard so that the sponsor has a complete picture and can analyze the current aspects of the study that require attention and quality enhancement.

The study quality control statistics are represented by pie charts and bar charts. Pie charts show the proportions of a whole with each slice representing a category’s contribution to the total. Bar charts compare different categories or groups with each bar representing a category’s value. These charts are best for depicting trends or comparing multiple categories.

To analyze the study quality control statistics

  1. In the CTMS application header, select the DASHBOARD tab.

  2. On the page that opens, select the Study Insights tab.

  3. From the Category dropdown menu, select the Clinical Study > Study Quality Control category of reports.

    Accessing study quality control statistics
    Figure 1. Accessing study quality control statistics

  4. From the Study dropdown menu, select the study for which you want to review the statistics.

    Optionally, from the Site dropdown menu, select the specific site for which you want to review the statistics.

    Selecting study and site for quality control statistics
    Figure 2. Selecting study and site for quality control statistics

  5. In the charts of the Study Quality Control dashboard, analyze the details as explained in the following table.

    Analyzing study quality control statistics charts
    Figure 3. Analyzing study quality control statistics charts

    Chart

    Details

    Protocol Deviation

    Represents the bar chart that depicts the number of registered protocol deviations at the study, site, and subject levels. This helps you understand the statistics of protocol breaches and take measures to eliminate them.

    An example of study-level protocol deviation can be the administering of drug dosage different from the one established by protocol by all the study sites.

    An example of site-level protocol deviation can be the recruitment of a patient who does not meet requirements established by protocol at a certain site.

    An example of subject-level protocol deviation can be the subject taking additional medications that they are supposed to stop taking upon entering the study as a participant.

    PD Custom

    Represents the pie chart that depicts the number of registered custom protocol deviations at the study, site, and subject levels. Custom deviation refers to a situation that departs from the established protocol. Custom deviation can be introduced to suit specific study needs or circumstances.

    For instance, the sponsor can have a custom category of protocol deviations that caused the adverse event or prevented the subject from participating in the study.

    To customize the chart data, select the needed parameters from the Level and By dropdown menus.

    Monitoring

    Represents the bar chart that depicts the statistics on all monitoring visit types per each study site. The monitoring type can be one of the following: PSSV (Pre-Study Site Visit), SIV (Site Initiation Visit), IMV (Interim Monitoring Visit), or COV (Close Out Visit).

    To customize the depicted chart data, select the Site value. Then in the dialog that opens, select the sites for which you want to review monitoring statistics and save the applied changes.

    Selecting sites to adjust monitoring chart statistics
    Figure 4. Selecting sites to adjust monitoring chart statistics

    Monitoring Visits by Phase

    Represents the bar chart that depicts the statistics on monitoring visits at various stages—planning, amendment, trip report completion, finalization, and so on.

    PD by Status

    Represents the bar chart that depicts the statistics on protocol deviations of various statuses—initial, completed, reviewed, or else.

    Tip

    Optionally, from the bottom right, you can select the following options:

    • eTMF: select to access the study's overview in the Electronic Trial Master File (eTMF) application.

    • Show Reports list_icon.png: select to access the reports pertinent to study quality control presented in table-view for your convenience. Switch between the available tabs to access and review all the data.

      Reviewing study quality control reports
      Figure 5. Reviewing study quality control reports

      If required, you can also export the data displayed in this table.

      Click Show Charts switch_icon.png to go back to the chart view.

You have reviewed the study quality control statistics for a study. You can also export the report details if you prefer working with data offline.

In this section:

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 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.

Any person, company, institution, group, or organization that is a client of EDETEK and a user of the eClinical system.

In the eClinical system, the Sponsor role is assigned to the user who oversees or pays for a clinical trial and collects and analyzes the data. Before the study goes live, the Sponsor users work closely with the data managers, configuring CRFs and other aspects to make sure everything meets their requirements before giving the green light for the study to go live. In the course of a trial, the Sponsor users make requests for amendments in the system according to a new protocol version, changes in business requirements, or other needs.

Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

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 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 electronic version of a trial master file (TMF) is a type of content management system for a clinical trial used to organize and store files required for compliance with government regulatory authorities like the FDA, EMA, or others.

Get to know all the possibilities of the app with the comprehensive eTMF User Guide.