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Edit visit window dates and reason in subject management

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, in EDC, from the STUDY INFO tab, the study designers and protocol managers can use the data for administrative purposes to plan and set up the clinical trial. It 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 explore how to edit the dates and the reason for changing the date of a particular visit window.

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 STUDY INFO tab.

  2. On the page that opens, in the left pane, expand the Subject option.

  3. In the menu that appears, select the Subject Information subtab.

  4. 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

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

    Filtering visit window list
    Figure 2. Filtering visit window list

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

  7. In the Edit Window Date dailog that opens, all the fields are populated from SD. Update the required settings as explained in the following table.

    Editing visit window
    Figure 3. Editing visit window

    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 when the visit is most preferable 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 completed the visit date A will remain 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 made, the visit window is updated.

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.

Study Designer (SD)

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.