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View form status details report

The Form Status Details report displays all the case report forms (CRFs) configured for the study and their current completion progress in terms of data collection as well as review and approval activities. In this report, you can find all the required details: the form name, for which site, visit, and subject the form is supposed to be completed, any manual or system queries waiting for resolution on this form, and other details.

To view the form status details report

  1. In the EDC 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 Form Status Details.

    Accessing form status details
    Figure 1. Accessing form status details

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

    Analyzing form status details
    Figure 2. Analyzing form 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 CRF on which the data is captured.

    Status

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

    • Initial: the data collection is not initiated.

    • Temp Save: the data collection is initiated, but the CRF is saved to be edited later and not yet submitted.

    • Incomplete: the data collection is initiated but the CRF is not completed yet.

    • Complete: the data collection is completed for all mandatory fields and the CRF is submitted.

    Open Manual Queries

    Represents one of the following:

    • Yes: there are open manual queries awaiting resolution for the CRFs, its records, or items.

    • No: there are no open manual queries awaiting resolution for the CRFs, its records, or items.

    Answer Manual Queries

    Represents one of the following:

    • Yes: there are answered (resolved) manual queries for the CRFs, its records, or items.

    • No: there are no answered (resolved) manual queries for the CRFs, its records, or items.

    Open System Queries

    Represents one of the following:

    • Yes: there are open system queries awaiting resolution for the CRFs, its records, or items.

    • No: there are no open system queries awaiting resolution for the CRFs, its records, or items.

    Answer System Queries

    Represents one of the following:

    • Yes: there are answered (resolved) system queries for the CRFs, its records, or items.

    • No: there are no answered (resolved) system queries for the CRFs, its records, or items.

    DM Review

    Represents one of the following:

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

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

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

    CRA Review

    Represents one of the following:

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

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

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

    Safety Review

    Represents one of the following:

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

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

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

    SDV

    Represents one of the following:

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

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

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

    Softlock

    Represents one of the following:

    • Yes: the CRF is soft-locked after the needed review stages are completed.

    • No: the CRF is not soft-locked.

    • N/A: the soft-lock functionality does not apply to this CRF.

    Sign

    Represents one of the following:

    Hardlock

    Represents one of the following:

    • Yes: the CRF is hard-locked after the needed review stages and PI signature are completed.

    • No: the CRF is not hard-locked.

    • N/A: the hard-lock functionality does not apply to this CRF.

    Next Level

    Select the corresponding hyperlink to go to other reports as follows:

    • Record: go to the record status details report and view in-depts data on the records completion pertinent to this CRF.

      This link is only available for log forms with multiple records within, for instance, Adverse Event (Details) or Medical and Surgical History (Details).

    • Item: go to the item status details report and view in-depts data on the completion of the CRF items (fields).

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 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.

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.