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Send data to PV

PV uses the data of a specific subject collected and captured in CRFs via EDC. For PV to get the data extracted from EDC, the principal investigator (PI) of a site or a designee has to create a task via the EDC > Safety Gateway functionality.

Important

To access the Safety Gateway functionality in EDC, make sure you have all the required permissions granted via the ADMIN application. For more details, contact the EDETEK administrator.

Once the task has been created, you can review all the data records extracted within the task and send them to the PV application.

To send the extracted data to PV

  1. In the EDC application header, select the SAFETY GATEWAY tab.

  2. On the page that opens, in the left pane, select the Task Management subtab.

  3. In the Task List table that appears, go to the task the records of which you want to send to PV. In the Actions column next to the task, select Review review_icon.png.

    Selecting to review task
    Figure 1. Selecting to review task

  4. On the page that opens, in the left pane, review the data under all the subtabs as explained in the following table.

    Selecting subtabs to review and manage extraction task details and data
    Figure 2. Selecting subtabs to review and manage extraction task details and data

    Element

    Details

    General

    Represents general information about the extracted data within the task, such as case country and language, adverse event (AE) category, report type, and more.

    Study

    Represents general study data, such as registration number and country.

    Reporter

    Represents information about the user who has created the task, such as user name, organization, and other contact information.

    Patient

    Represents the patient's demographic data, medical history, and death (if it occurred).

    Patient Drug History

    Represents information on relevant drugs previously administered to the patient and that has been stopped before the AE onset.

    Lab Test

    Represents the details of all the laboratory tests taken for the subject during the clinical trial.

    Product

    Represents the investigational products and the concomitant medication taken/used by the subject during the clinical trial, their dosage, substance, and indication.

    Event

    Represents all the events (AE/SAE) that occurred with the subject during the clinical trial and their details.

    Assessment

    Represents the subject's AE/SAE causality assessments.

    Narrative

    Represents a focused, factual, and clear description of the case, including the words or short phrases used by the reporter.

    Source

    Represents an option to upload the source document to follow the AE/SAE data.

    Re-Create

    Select re-create-button.png to create the task over if the current version is not satisfactory for some reason.

    When deciding to recreate the initial task, the system takes you to the page for creating the initial task, rather than the follow-up task page.

    When deciding to recreate the follow-up task, the system takes you to the page for creating the follow-up task, rather than the initial page.

    Save

    Select save_button_red_white.png to save the implemented changes at any of the subtabs.

    SEND TO PV

    Select send_to_pv_button.png to send the data to the PV application.

    Once selected, in the Confirm dialog that opens, enter your credentials and select the PV user to handle the data on the PV side, then select confirm_button_red_white.png.

    The list of assignees is based on their study access permission granted via ADMIN.

    Confirming sending data to PV
    Figure 3. Confirming sending data to PV

    CANCEL

    Select cancel_button.png to discard the implemented changes at any of the subtabs.

Upon confirmation, the data is sent to the PV application. The assigned PV user receives an email notification including the link to easily access the system and the specific page that requires attention. To open the needed page, the user must log in to the system upon clicking the link.

See also
In this section:

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

See also eCRF.

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.

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.

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 eClinical application that represents an administrative system used to manage users, authorities, and sponsors at the company level. It provides studies, sites, and sponsors with high-granularity role-based access management across all eClinical applications.

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.