Skip to main content

View item status details report

The Item Status Details report displays the statistics of completion and review for individual fields of the case report forms (CRFs) configured for the study. In this report, you can find all the required details: for which site, visit, and subject the form items are completed, any manual or system queries waiting for resolution, and other details.

To view the item status details report

  1. In the application header, select the REPORTS tab.

  2. On the page that opens, in the left pane, select the CRF Status subtab to expand the list of available reports and select Item Status Details.

    Accessing item status details
    Figure 1. Accessing item status details

    Tip

    In the Next Level column of the grid, you can select a corresponding hyperlink to go to another page where you can view the CRF item details pertaining to any item and make the necessary changes if needed.

  3. In the Item Status Details table that opens, analyze the data as explained in the following table.

    Analyzing record status details
    Figure 2. Analyzing record status details

    Important

    The available statuses depend on the review and approval stages configured for your study via EDC and SD.

    Column

    Details

    Site Code

    Represents the code of the site where the data collection occurs.

    [Unique ID Label]

    Represents the unique identifier of the subject for whom the data collection occurs.

    The column name depends on the unique ID label configuration of your study in IWRS.

    Visit Name

    Represents the name of the subject visit at which the data collection occurs.

    Form Name

    Represents the name of the log CRF to which the data record belongs.

    Record SN

    Represents the sequential number of the record of the CRF on which the data is captured.

    Question

    Represents the name of the item for which the data is entered.

    Caption

    Represents the question text visible on the CRF for which the data is entered.

    Variable

    Represents the individual piece of collected data that is captured and stored in the respective domain. It represents a specific attribute or characteristic that can vary among subjects in a study.

    For instance, the AETERM variable captures the verbatim term outlining the adverse event for the patient, such as "Fever," "High blood pressure," and so on, and the AESTDAT variable always captures the date when the adverse event started.

    Current Value

    Represents the data entry currently recorded on the CRF for the respective question.

    Status

    Represents the current state of the item in terms of data collection:

    • Initial: the data collection for the form where the item resides is not initiated or not submitted.

    • Incomplete: the data is entered for the item but the form where the item resides is not completed yet.

    • Complete: the data collection is completed for this item and the form is submitted.

    DM Review

    Represents one of the following:

    • Yes: the data review for the item is completed by the data manager (DM).

    • No: the data review for the item is not completed by the DM.

    • N/A: the DM review does not apply to this item.

    CRA Review

    Represents one of the following:

    • Yes: the data review for the item is completed by the clinical research associate (CRA).

    • No: the data review for the item is not completed by the CRA.

    • N/A: the CRA review does not apply to this item.

    Safety Review

    Represents one of the following:

    • Yes: the data review for the item is completed by the safety team.

    • No: the data review for the item is not completed by the safety team.

    • N/A: the safety review does not apply to this item.

    SDV

    Represents one of the following:

    • Yes: the source data verification (SDV) is completed for the item.

    • No: the SDV is not completed for the item.

    • N/A: the SDV does not apply to this item.

    Next Level

    Select the CRF Item hyperlink to access the respective form under the DATA ENTRY tab and update the data entry if needed.

Once the report details are studied, you can leave the page or perform other suggested manipulations.

In this section:

A specialized document in a clinical trial designed to collect the subject data.

See also eCRF.

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.

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 eClinical, queries are created to ask a question or get feedback from a designated system user on a particular data item. There are two types of queries in the system:

  • Manual query: these are created by the system users and assigned to responsible users to address the issues and either correct them or confirm the data's accuracy.

  • System query: these are generated automatically by the system and require user interaction to manage and resolve them.

An eClinical application that is mainly used to collect and manage subject data during clinical trials. It integrates with the Study Designer (SD) application and uses preconfigured there case report forms (CRFs) to complete data collection and management. It also provides an audit trail, data alert, source data verification (SDV), payment management, adjudication, and other functions as well as supports data export according to the CDISC ODM standard.

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

An eClinical application that provides functionality to design and configure a study (clinical trial), namely to configure CRFs, set subject phases, visits, and others.

The application supports the design of the CDSIC ODM-compliant electronic CRFs to support EDC and eDiary data collection and management.

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

An eClinical application that represents unified and configurable subject randomization and trial supply management tool for subject grouping, drug inventories, shipments, and dispensations, as well as other vital processes during a clinical trial.

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

A specific area or category of data within a clinical trial that encompasses a set of related variables that share a common theme. Each domain organizes data to facilitate analysis and reporting, ensuring that information is structured and easily interpretable.

For example, in a clinical trial, domains might include demographics, efficacy, safety, and laboratory results.

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 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.