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Edit visit window dates and reason in data entry

In a clinical trial, a visit window defines the allowable time span for a subject visit in case it is impossible to conduct that visit on the exact scheduled visit date.

Tip

Data managers (DM) define visit windows and their anchors in the Study Designer (SD) app. Then these settings are automatically populated in the EDC application in the corresponding visit.

Once the window settings are populated from SD, from the DATA ENTRY module of EDC, the clinical research coordinator (CRC), clinical research associate (CRA), and other site personnel can utilize it for operational aspects to enter and manage data of each visit. It also reminds the subject about the next visit occurrence in advance. Also, the experts may need to check the visit windows for mistakes and whether the visit windows are in the permitted window ranges.

In this section, you can learn how to edit the dates and reason for a visit window of a particular site.

Important

You cannot edit the visit window dates and reason for such visit(s) that are not initiated and are currently in Not Reached status.

To edit visit window dates and reason

  1. In the EDC application header, select the DATA ENTRY tab.

  2. In the open site list, select the needed site.

  3. In the open subject list, select Switch to Visit Window switch_icon.png.

    Switching to visit window page
    Figure 1. Switching to visit window page

  4. On the Visit Window List page, apply the needed filters to narrow down the list of visit windows.

    Filtering visit window list
    Figure 2. Filtering visit window list

  5. In the table with a list of visit windows, next to the needed visit window, select Edit Visit Window edit_pen_01.jpg.

    Edit Visit Window option
    Figure 3. Edit Visit Window option

  6. In the open Edit Visit Window dialog, all the fields are populated from SD. Update the required settings as explained in the following table.

    Editing visit window details
    Figure 4. Editing visit window details

    Tip

    In the following table, mandatory elements are marked with an asterisk (*).

    Element

    Details

    Subject ID

    A read-only unique value that identifies the subject against the protocol of a clinical trial.

    Visit Name

    A read-only unique value that identifies the visit against the protocol of a clinical trial.

    Window Type*

    Select the type of the visit window:

    Scheduled Visit Date

    A date that is the most preferable for the visit to occur.

    Earliest Visit Date

    A date when the visit interacts first with the clinical trial.

    Latest Visit Date

    A date when the most recent interaction occurred in the visit.

    For instance, if a patient had a scheduled visit planned on date A, once the patient completes the visit, date A remains the latest visit date until the next visit.

    Change Reason*

    The reason for the visit window changes introduced. If applicable, select one of the predefined reasons or enter your own:

    • Medical decision approved by sponsor

    • Patient's requests or medical reasons (which also include their inability to attend)

    • Sponsor's requirement

    • Rescheduling due to holidays or weekend

    • Rescheduling due to AE or SAE

    • Others, specify: select this option to enter your custom reason.

      Once selected, the input field opens in which you can introduce the reason for the visit window changes.

    SAVE

    Select save_button_white_red.png to save the changes introduced.

    CANCEL

    Select cancel_button_white_blue.png to discard any changes and close the dialog.

After the changes are saved, the visit window is updated.

See also
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.

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 person responsible for the successful planning, execution, and management of clinical trials. The CRC’s scope of work might include study preparation, site setup, patient recruitment, regulatory compliance control, data collection, and more.

In the eClinical system, the Clinical Research Coordinator (CRC) user role is granted to a person who works on a site with subjects and is responsible for entering data to EDC, ensuring the data is entered correctly according to all requirements, and answering queries from data managers on any questionable data pieces.

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.

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.

Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

An adverse event that results in death, is life-threatening, requires subject hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.