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Nullify data extraction task

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.

When the initial task has been created and sent to PV, and in EDC, you have some new data to follow the sent one, you can add a follow-up task for the previous data. However, if the task has been erroneously added to EDC, you can nullify it if needed.

To nullify a data extraction task

  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. On the Task Management page that opens, select Follow-up follow-up_icon.png next to the task that needs to be nullified.

    Important

    The Follow-up option is available only if the transmission status of the task is Successful.

  4. In the Create Follow-up Task dialog that appears, select the Nullification task type and enter the reason for nullifying a task.

    Creating follow-up task
    Figure 1. Creating follow-up task

    Important

    Bear in mind, that after nullifying a follow-up task, you can no longer create other follow-ups for this task afterward.

  5. Select confirm_button.png.

Once confirmed, the task is nullified and a corresponding record is added to the Task Management grid.

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.