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Change form status per visit from subject metrics

The status change means you can change the review status, softlock, or provide your signature for the forms within a specific visit before hardlocking 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 (DM), clinical research associate (CRA), principal investigator (PI), or other review stages.

In the EDC application, with the Metrics functionality, you can manage the statuses of your forms per subject visit.

Important

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

To change the form status per per visit from the subject metrics

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

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

    Accessing subject summary
    Figure 1. Accessing subject summary

  3. On the page that opens, from the Subject ID filter, select the subject whose visit and form metrics you want to access.

    Selecting subject to show metrics
    Figure 2. Selecting subject to show metrics

  4. In the table that appears, locate the visit and its form for which you want to change the status.

    Locating subject visits and forms
    Figure 3. Locating subject visits and forms

  5. Select the form status and from the dropdown menu that appears, select the needed one.

    Changing form status
    Figure 4. Changing form status

    Tip

    You can select Go to CRF go_to_CRF_icon.png to go and review the form data before changing the status.

    For activation and inactivation options, you have to provide the reason before the action can be applied. See more in the Activate/Inactivate visit from study metrics section.

Once done, the status of the form is changed.

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 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.