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Analyze clean site tracker of pending monitoring visits and tasks

A monitoring visit refers to an activity when 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.

While configuring a site, using the Clean Site Tracker functionality, you can monitor and manage site compliance and outstanding tasks related to monitoring visits, risk assessment, and protocol deviations. It provides an overview of completed and ongoing visits, highlights overdue tasks, such as pending trip report submissions and approvals, and tracks pending Source Data Verification (SDV) and Source Data Review (SDR) forms. Additionally, it monitors Key Risk Indicators (KRIs), incomplete action items, and protocol deviations (PDs) to ensure sites remain compliant and study activities progress smoothly.

To analyze the clean site tracker of pending monitoring visits and 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. From the left pane of the study page that opens, select Study Details > Site List.

    Accessing study sites
    Figure 3. Accessing study sites

  3. In the Site List table that appears, in the Site Name column, select the needed site or select Edit pencil_icon.png next to it.

    Accessing option to configure site
    Figure 4. Accessing option to configure site

  4. On the page that opens, two panes appear. The left pane groups sites by country or region, where you can expand or collapse sections and select a specific site. The middle pane displays the contents of the currently opened site.

    From the horizontal navigation pane provided, select Clean Site Tracker.

    Accessing clean site tracker option
    Figure 5. Accessing clean site tracker option

  5. On the page that opens, analyze the monitoring visit and other compliance task details as follows:

You have analyzed the essential insights and pending tasks to ensure the smooth functioning of the trial processes and site compliance.

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.

In a clinical trial, a location where the subject treatment and drug dispensation occur. It can be a hospital, a private laboratory, or other institutions.

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 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 process of ensuring data accuracy and integrity within a clinical trial. SDV involves the review and comparison of data recorded in the source documents against the data captured on the case report forms (CRFs). During SDV, a trained monitor or clinical research associate (CRA) compares the source data to the CRFs to identify any discrepancies or errors. They may review laboratory results, medical history, adverse event records, and other relevant information. Discrepancies found during SDV are usually documented and resolved through data clarification or query processes with the site personnel responsible for data collection.

A process of ensuring data accuracy and integrity within a clinical trial. SDR refers to a broad assessment and review of the source data beyond a simple verification process. It involves a comprehensive review of the collected subject data to evaluate its quality, consistency, and compliance with the study protocol, standard operating procedure, and regulatory requirements. During SDR, the clinical research associate (CRA) or data manager (DM) examines the data for completeness, accuracy, and compliance with the established criteria. They analyze trends, perform data reconciliations, and identify any potential anomalies or issues that may require further investigation or data clarification.

A specific measurement used to monitor and assess potential risks associated with the conduct of the trial. They provide early warning signs of potential issues or deviations that may impact participant safety, data integrity, or the overall success of the study.

Examples of KRIs can be AE report timeliness or query resolution time. The delays in both activities may be considered a sign of the study personnel's neglect. Thus, monitoring is required to ensure the proper conduction of trial activities.

In CTMS, a finding that is discovered during a monitoring visit at a site and requires resolution. Issues can take many forms, depending on the nature and severity of the finding. An issue may also involve correcting data errors in subject records.