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View visit status details report

The Visit Status Details report displays all the visits configured for the study and all the pertinent details, such as name and status (happened or not), subject participating in the visit, data captured, reviewed, and signed throughout the visit, queries, if any, waiting for resolution, and so on.

To view the visit 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 Visit Status Details.

    Accessing visit status details report
    Figure 1. Accessing visit status details report

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

    Analyzing visit status details report
    Figure 2. Analyzing visit status details report

    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.

    Status

    Represents the current state of the visit in terms of its occurrence and data collection:

    • Initial: the data collection is not initiated for CRFs associated with this visit.

    • Incomplete: the data collection is initiated for CRFs associated with this visit but has not been completed yet.

    • Complete: the data collection is completed for all CRFs associated with this visit.

    Status Flow

    Represents one of the following:

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

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

    Answer Manual Queries

    Represents one of the following:

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

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

    Open System Queries

    Represents one of the following:

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

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

    Answer System Queries

    Represents one of the following:

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

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

    DM Review

    Represents one of the following:

    • Yes: the data review for all CRFs associated with this visit is done by the data manager (DM), which gives the DM Review status for the visit as a whole.

    • No: the data review for the CRFs associated with this visit is not completed by the DM.

    • N/A: the DM review does not apply to this visit and its CRFs.

    CRA Review

    Represents one of the following:

    • Yes: the data review for all CRFs associated with this visit is done by the clinical research associate (CRA), which gives the CRA Review status for the visit as a whole.

    • No: the data review for the CRFs associated with this visit is not completed by the CRA.

    • N/A: the CRA review does not apply to this visit and its CRFs.

    Safety Review

    Represents one of the following:

    • Yes: the data review for all CRFs associated with this visit is done by the safety team, which gives the Safety Review status for the visit as a whole.

    • No: the data review for the CRFs associated with this visit is not completed by the safety team.

    • N/A: the safety review does not apply to this visit and its CRFs.

    SDV

    Represents one of the following:

    • Yes: the source data verification (SDV) is completed for all CRFs associated with this visit that are intended for such verification, which gives the SDV status for the visit as a whole.

    • No: the SDV is not completed for all the CRFs associated with this visit and intended for such verification.

    • N/A: the SDV does not apply to this visit and its CRFs.

    Softlock

    Represents one of the following:

    • Yes: all the CRFs and the visit itself are soft-locked after the needed review stages are completed.

    • No: the visit is not soft-locked.

    • N/A: the soft-lock functionality does not apply to this visit and its CRFs.

    Sign

    Represents one of the following:

    • Yes: all the CRFs and the visit itself are signed by the principal investigator (PI).

    • No: the visit is not signed by the PI.

    • N/A: the PI signature functionality does not apply to this visit and its CRFs.

    Hardlock

    Represents one of the following:

    • Yes: all the CRFs and the visit itself are hard-locked after the needed review stages and PI signature are completed.

    • No: the visit is not hard-locked.

    • N/A: the hard-lock functionality does not apply to this visit and its CRFs.

    Next Level

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

    • Form: go to the form status details report and view in-depts data on this visit's CRFs and their progress.

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

    • Item: go to the item status details report and CRF items (fields) completion pertinent to this visit.

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

See also
In this section:

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.

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

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.

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 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.