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Change visit, subject, or site status from study metrics

The status change means you can change the review status, soft lock, or provide your signature for the visits, subjects, and sites before hard locking the study. The review statuses available here depend on which stages of review are configured as required for your study data, such as data manager's (DM), clinical research associate's (CRA), or principal investigator's (PI) review, safety review, and so on.

The status flow is similar to what you can perform under the DATA ENTRY tab, only here, you can do this in batch on the visit or subject level.

For instance, you can change the Screening visit status to DM Review and by doing so, all the completed forms of this visit acquire the same status.

Another example is that when you change the subject's status to DM Review, the statuses of all the completed visits of this subject also change to DM Review.

Important

The actions availability and dependencies are configured for your study and sites under the Status Configuration functionality of EDC.

To change the visit, subject, or site status from the study metrics

  1. In the EDC application header, select the STUDY INFO tab.

  2. On the page that opens, in the left pane, select Metrics > Study Summary.

    Accessing study summary
    Figure 1. Accessing study summary

  3. In the table that appears, locate the visit, subject, or site for which you want to change status, apply soft or hard lock, or provide a signature. Then select the status and from the dropdown list of available options, select the needed one.

    Changing status
    Figure 2. Changing status

    Tip

    Hover over the status icon to see its legend or address the icon list section of the Quick panel for more information on all the icons you see in EDC.

  4. In the Confirm dialog that appears, select confirm_button.png to proceed with your performed operation.

    Confirming review status change
    Figure 3. Confirming review status change

  5. For the signature operation, in the Enter User Signing Password Information dialog that appears, provide your electronic signature details as explained in the following table.

    Providing electronic signature
    Figure 4. Providing electronic signature

    Tip

    In the following table, mandatory elements are marked with an asterisk (*).

    Element

    Details

    Username or Email*

    Enter your username or email that you use to log in to the eClinical applications.

    Send Code

    Select send_code_button.png to send the temporary PIN code to your email for which the SSO method is configured.

    The button is only available if you use the authorization method via SSO.

    Code*

    Enter the temporary PIN code that you received via email.

    The field is only available if you use the authorization method via SSO.

    Password*

    Enter the password that you use to log in to the eClinical applications.

    The field is only available if you use the authorization method by providing your login and password.

    Submit Electronic Signature

    Select submit_electronic_signature_button.png to confirm your action with your signature and save the implemented changes.

    x_icon.png

    Select this icon to discard your action, close the dialog, and return to the Study Summary page.

    Important

    For security, the system logs you out after three failed attempts to confirm your identity with a password or code.

Once confirmed, the status of the visit, subject, or site is changed.

See also
In this section:

An occurrence in a clinical trial in which the subject comes to a site to receive treatment, undergo some tests, or complete other required procedures.

A participant who is enrolled in a clinical trial and assigned to the site.

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 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 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 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 review of data collected via CRFs, especially those related to adverse events and serious adverse events data records. The safety review is intended to identify any risks related to subject safety. This review can be done by physicians, pharmacovigilance teams, or other dedicated personnel as per study protocol.