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View audit trail for safety data extracted from PDF

With the PDF Import functionality, you can import safety data from the unstructured source documents, such as scanned SAE forms in the PDF format. The files can be uploaded manually or you can configure the email intake to pull the files automatically from the predefined mailbox and land them to PV for further processing. Based on the preconfigured template, the system is able to analyze and transcribe the file to retrieve the data and create an ICSR in PV.

Once the data is reviewed and the ICSR is successfully imported into PV, or at any time during these processes, you can view the audit trail—a log of all performed operations from the moment of the file upload and up to date. This functionality might be of help if you need to reconstruct the course of the events with the imported data for a specific case.

To view the audit trail for the safety data extracted from PDF

  1. In the PV application header, select the INTAKE tab.

  2. From the left pane that appears, select PDF Import.

    Accessing PDF import
    Figure 1. Accessing PDF import

  3. On the PDF Import page that opens, locate the record for which you want to review the audit trail. Then from the Actions column next to the record, select More more_icon.png > Audit Trail list_icon_gray.png.

    Tip

    You can see the cases based on the study access permission granted via ADMIN.

    Accessing audit trail for extracted safety data
    Figure 2. Accessing audit trail for extracted safety data

  4. In the dialog that appears, review the audit trail for your extracted safety data—which operations were performed on it, when, and by whom.

    Viewing audit trail for extracted safety data
    Figure 3. Viewing audit trail for extracted safety data

  5. Select ok_button_red_white.png to close the dialog.

Once selected, you are returned to the PDF Import page. You have viewed the audit trail for the safety data imported from PDF.

In this section:

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.

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 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.