Compare extracted ICSR data to existing cases
In PV, you can create ICSRs using the E2B R3 import by uploading an XML file with your case data or receiving such a file via a gateway. Once the file is imported and processed, the resulting ICSR data must be reviewed to enable further ICSR management.
While reviewing the data, if the system detects any similar cases in the file being imported to the cases existing in the system, it provides you with the option to compare data and decide on further actions with it.
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In the PV application header, select the INTAKE tab.
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On the page that opens, from the left pane, select E2B R3 Import.
Figure 1. Accessing E2B R3 import
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Based on where your imported file resides, select the Manual Upload or Gateway Received tab.
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In the table that appears, locate the record of your interest and from the Actions column next to it, select Edit
.
Figure 2. Selecting to edit import record
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On the page that opens, go to the ICSR table and locate the report for which you want to perform a comparison. Then from the Actions column next to it, select Review
.Tip
You can see the uploaded files with cases based on the study access permission granted via ADMIN.
Figure 3. Selecting to review ICSR
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On the resulting page, you can review your data beforehand, or go directly to comparison by selecting
.Tip
You can see the duplicate cases based on the study access permission granted via ADMIN.
Figure 4. Selecting to compare data
Important
If the uploaded XML file is a follow-up on the existing case, and there are duplicated records within the same form, the system prompts you with a dialog detecting the duplicated records. Fix the records to make them unique or delete unnecessary duplicates, otherwise, you cannot proceed with this follow-up creation.
Figure 5. Detecting duplicated records
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On the data comparison page that opens, see the duplicated data elements in various forms and select the checkboxes next to the data with which you want to proceed in your data import—the value from the imported file or the one that currently exists in the system.
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.
Figure 6. Searching for duplicates
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While reviewing, if detecting the records that you want to merge or split, right-click such a record, select Reassociate
, 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
.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.
Figure 7. Reassociating similar records
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To split the records that were automatically merged by the system but must be separated, in the resulting dialog, select the –– option. Then click
.
Figure 8. Disassociating merged records
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Once the selection is made, proceed with one of the available options as explained in the following table.
Action
Details
Select this button to save the implemented changes.
Select this button to update the ICSR existing in PV with new data without creating additional follow-up versions. Then proceed to the next step.
Select this button to import the report as follow-up data on the case that exists in the PV system. Then proceed to the next step.
Select this button to reject the imported ICSR. Then proceed to the next step.
Select this button to cancel the duplicate search and return to the case import page.
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If you are updating, following up, or rejecting the imported ICSR, then in the confirmation dialog that opens, fill in the requested details as explained in the following table.
Figure 9. Confirming your action
Tip
In the following table, mandatory elements are marked with an asterisk (*).
Element
Details
User Name
Automatically populates with the user name of the current user and cannot be manually changed.
Password*
Enter the password that you use to log in to the eClinical system.
Assigned PV User*
Select the user to be assigned for the ICSR processing in PV. Upon confirmation, this user gets an email notification to process the new data in PV.
This field is only available for importing data as a follow-up report.The list of assignees is based on their study access permission granted via ADMIN.Significant*
Select one of the following options:
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Yes: select this option if the follow-up report contains new information that needs to be submitted to regulatory authorities.
The definition of clinical significance varies per sponsor, but mostly it requires new information or changes in the previous reports concerning one of the four validity criteria—identifiable reporter, identifiable patient, adverse event, or suspect medicinal product. Other information that may impact the overall clinical significance of the case is any change in causality assessment, study information, concomitant medications, medical history, and so on.
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No: select this option if the follow-up report does not need to be submitted to regulatory authorities.
For instance, a change of the status of a MedDRA code or term from current to noncurrent due to a MedDRA version change can be considered non-significant as long as it has no impact in the medical context of the case.
This field is only available for importing data as a follow-up report.Comment
Enter a comment to follow your data if needed. This comment is included in the notification email for the assigned user, so you can use it to communicate any specific details to them.
This field is mandatory for the rejection operation.CONFIRM
Select
to proceed with the intended action.CANCEL
Select
to discard the implemented changes. -
Once confirmed, the selected operation is performed. If the data is imported, the resulting ICSR can be further managed according to the purpose of the import and the standard operation procedures (SOP) or work instructions (WI) of the company.