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Review imported follow-up data for manually created ICSR

In PV, the AE and SAE data used to create Individual Case Safety Reports (ICSR) is pulled from EDC via managing respective tasks for data extraction. As soon as the data is sent from EDC to PV, it lands under the INTAKE > EDC Import tab, and the system alerts you via email that there is new safety data to review. Data review at this point is intended to validate the data as ready for ICSR management.

The incoming data from EDC can be new (an initial case report) or follow-up (include more information on the already existing report in PV).

If the initial report is imported to PV from EDC, all the follow-up data on it can be detected by the system and marked as Follow Up automatically. However, if the initial report was created manually in PV and more data on this case is then imported from EDC, then the system cannot autodetect it as a follow-up. The user in charge must review the imported data and associate it with the respective initial case.

For instance, the initial SAE case is entered in PV manually from the site-provided paper form.

Then, according to the obligatory protocol, the respective SAE case record is made in EDC, and more details on the case progress are recorded. Then this data is pushed to PV.

Once the case lands in PV's intake, it must be reviewed and recognized as a follow-up to be associated with the respective initial case to align the two entries as one progressing SAE.

To review imported follow-up data for manually created ICSR

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

    Accessing intake management
    Figure 1. Accessing intake management

  2. On the page that opens, in the left pane, select the EDC Import subtab.

  3. In the EDC Import List that appears, locate the unprocessed safety data that you need to review, and in the Actions column next to it, select Review review_icon.png.

    Accessing imported case review
    Figure 2. Accessing imported case review

    Tip

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

    To locate the needed safety data faster, filter the table by study name, site code, subject ID, or other parameters.

  4. On the page that opens, select duplicate_search_button.png.

    Accessing duplicate search
    Figure 3. Accessing duplicate search

  5. On the Duplicate Search page that appears, select the checkboxes next to the data elements by which you want to retrieve similar cases. This helps you find the initial manually-created report in PV for which you are reviewing the follow-up version. Then select search_magnifying_glass_button_red.png.

    Searching for duplicate cases
    Figure 4. Searching for duplicate cases

  6. In the search result table, locate the case that is the initial ICSR for which the reviewed data serves as a follow-up. Then next to it, select Compare compare_icon.png.

    Selecting to compare initial case with follow-up
    Figure 5. Selecting to compare initial case with follow-up

  7. On the resulting page, compare the new—follow-up—details imported from EDC and the initial report data already available in PV and select with which data elements you want to proceed. From the tree on the left, switch between forms and review all data entries.

    Tip

    If the differences from the previous ICSR version are in the fields intended for review according to your study configurations, once the new version is created in PV, you need to translate such fields individually or using translation review.

    Comparing and updating initial data with follow-up
    Figure 6. Comparing and updating initial data with follow-up

  8. While reviewing, if detecting the records that you want to merge or split, right-click such a record, select Reassociate reassociate_icon.png, and do one of the following:

    • To merge the records that were created separately by the system but are supposed to be combined into one, in the resulting dialog, select the record with which you want to merge. Then click confirm_button_red_white.png.

      For instance, the system records “Lung effusion” and “Large pleural effusion” separately. These are verbatim used to record the same event in different reports. To avoid treating them as distinct occurrences, combine them into a single record.

      Reassociating similar records
      Figure 7. Reassociating similar records

    • To split the records that were automatically merged by the system but must be separated, in the resulting dialog, select the –– option. Then click confirm_button_red_white.png.

      Disassociating merged records
      Figure 8. Disassociating merged records

  9. Once the review and comparison process is completed, proceed with one of the available options as explained in the following table.

    Finalizing imported follow-up data review
    Figure 9. Finalizing imported follow-up data review

    Action

    Details

    save_button_red_white.png

    Select this button to save the implemented changes.

    update_button.png

    Select this button to update the initial ICSR existing in PV with new follow-up data imported from EDC without creating additional follow-up versions.

    This button is available if the initial case is in any status except for Case Submission or Case Archived.

    follow-up_button.png

    Select this button to create a follow-up ICSR version from the imported data.

    This button is available if the initial case is one of the following statuses: Case Submission or Case Archived status.

    reject_button.png

    Select this button to reject the imported case details.

    cancel_button.png

    Select this button to cancel the comparison and return to the case import page.

You have successfully reviewed imported follow-up data for manually created ICSR.

In this section:

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.

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 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.

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.