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Analyze eCRF summary details

In EDC Study Analytics, you can view different charts to get an instant insight into the current state of the EDC processes and data elements, such as sites, subjects' phases, opened/answered queries, and so on. The eCRF Summary bar chart is one of such charts provided in the dashboard that displays the total number of electronic case report forms (eCRFs), and the count of forms that currently exist in the following phases: Initial, Tempsaved, Completed, Incomplete, Unreviewed, DM reviewed, Softlocked, and Signed.

Using this functionality, you can view the summary details and get a detailed analysis of the eCRFs and the phases in which the eCRFs currently exist.

To analyze the eCRF summary details

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

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

    Accessing study analytics
    Figure 1. Accessing study analytics

  3. From the eCRF Summary bar chart, select Go Details info_icon.png.

    Selecting option to view eCRF summary details
    Figure 2. Selecting option to view eCRF summary details

  4. On the page that opens, in the eCRF Summary table, analyze the subject details as explained in the following table.

    eCRF summary details
    Figure 3. eCRF summary details

    Element

    Details

    Site Code

    Represents the site code of the subject for which the eCRF data is defined.

    Subject ID

    Represents the identification code of the subject for which the eCRF data is defined.

    Initial

    Represents the count of eCRFs that currently have no data in them.

    Tempsaved

    Represents the count of eCRFs that are currently saved as Draft.

    Completed

    Represents the count of eCRFs that are completed.

    Incomplete

    Represents the count of eCRFs that are incomplete, that is the forms that are partially filled and submitted by a user.

    Unreviewed

    Represents the count of eCRFs that are complete but require a review from the data manager (DM).

    DM reviewed

    Represents the count of eCRFs that are completed, reviewed, and approved by DM.

    Softlocked

    Represents the count of eCRFs that are soft-locked to prevent any changes in the form.

    Signed

    Represents the count of eCRFs that are completed and signed by the required personnel, most commonly, the principal investigator (PI).

    Hardlocked

    Represents the count of eCRFs that are completed, signed, and hard-locked by the required personnel.

    This column is only available if the hard lock functionality is enabled for the CRFs of your study.

Once you have analyzed the eCRF summary details, from the workspace toolbar, select switch_icon.png to go back to the Study Analytics page.

In this section:

An electronic version of a CRF that is a specialized document in a clinical trial designed to collect subject's data.

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.