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Create initial 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.

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.

To create an initial task for data extraction from EDC 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. On the Task Management page that opens, from the workspace toolbar, select New Initial Report add_new_icon.png.

  4. On the page that opens, complete the task setup process as follows:

    1. At the Select Site and Subject and your qualification step, select the respective values as explained in the following table.

      Selecting site, subject, and qualification
      Figure 1. Selecting site, subject, and qualification

      Tip

      Use search to locate the needed values faster.

      Element

      Details

      Site Code

      Select the site code at which the subject for whom you want to extract the data is registered.

      Subject ID

      Select the ID of the subject for whom you want to extract the data.

      Your Qualification

      Select your qualification, such as Physician, Pharmacist, or else. This data is required by the ICSR according to the ICH E2B (R3) standard.

      NEXT STEP

      Select next_step_button_red_white.png to proceed to the Select AE Record step.

      CANCEL

      Select cancel_button.png to discard changes and return to the Task List table.

    2. At the Select AE Record step, in the AE List table, select the adverse event(s) recorded for the previously selected subject the data for which you want to extract to PV, and select next_step_button_red_white.png to proceed to the Select Lab Test step.

      Selecting AE(s) to extract data
      Figure 2. Selecting AE(s) to extract data

      You can also select previous_button_red_white.png to return to the Select Site and Subject and your qualification step and change the selection if needed.

    3. At the Select Lab Test step, perform one of the following:

      Selecting lab tests to extract data
      Figure 3. Selecting lab tests to extract data

      Important

      To be able to extract the selected lab data records, make sure that the Extract Lab Test Records checkbox is selected. If this checkbox is cleared, the system does not extract any lab records.

      • To choose the specific data records for extraction, in the left pane, select the visit and laboratory test, and from the contents panel that appears, select the data records of your interest. Then select save_button_red_white.png to create the initial task for the selected data extraction in the EDC system.

      • To extract all the data for the selected AE(s), ensure the Extract Lab Test Records checkbox is selected and from the content panel, no specific lab test record is selected. Then select save_button_red_white.png to create the initial task for extraction to the PV system.

      • To return to the Select AE Record step and adjust the selection of AE(s), if needed, select previous_button_red_white.png.

Upon saving, the initial task for the extraction of the selected data records is added to Task List. You can now send the extracted data to PV.

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.

A safety service document that includes information required for reporting the adverse events and problems related to products and complaints filed by consumers with respect to any product.

An ICH standard of electronic transmission of individual case safety reports (ICSRs) data elements and message specification that must be incorporated according to ICH's Implementation Guide.

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.