E2B R3 import

Import Status

Select the status of the file import, such as Not Processed, Processed Success, Processed Failed, Complete Import, or Partial Import to search for files in a certain state of importing to the system.

E2B File

Enter the file name or part of it to search for files containing the entered element in their title.

N.1.2 Batch Number

Enter the unique tracking number assigned by the sender to each file to retrieve a file containing a specific case.

N.1.3 Batch Sender Identifier

Enter the identifier of the origin of the ICSR reports, such as, company name or regulatory authority to retrieve a file containing a specific case.

Case Number

Enter the unique ID that the ICSR obtains once the file is successfully reviewed and the new or follow-up case report is created based on it. This is helpful to find files based on which the ICSR is already created.

N.2.r.1 Message Identifier

Enter a unique tracking identifier assigned to a specific ICSR message transmitted by the sender to search for the file containing a specific case.

Process Status

Select the processing status of the report, such as Unprocessed, Initial Report, Update Report, Follow-up Report, and Reject Import to search for files in a certain state of validation.

Case Receipt Date

Select the date when the safety department received the most recent case data to search for the file containing a specific case.

Worldwide Unique Case ID

Enter the unique international identifier assigned to the case to search for the file containing a specific case.

Event Verbatim

Enter the original reporter's words or short phrases used to describe the first reported event to search for the files containing specific cases.

Sponsor Study Number

Enter the study number assigned by the sponsor to search for the files containing cases reported for a certain study.

Subject ID

Enter the unique identifier of a patient (subject) assigned to them by the sponsor in the course of a clinical trial to search for the files containing cases reported for a certain subject.

Reporter's Last Name

Enter the last name of the primary reporter of the case to search for the files with cases reported by the same person.

Reporter's First Name

Enter the first name of the primary reporter of the case to search for the files with cases reported by the same person.

Reporter's Qualification

Select one of the available qualifications of the primary reporter of the case to search for the files with cases reported by the same professional, for instance, risk manager, physician, and so on.

Reporter's Country

Select one of the available countries of the primary reporter's location to search for the files with cases reported in the same region.

Null flavor

Select next to the field to activate the options No Information, Masked, Unknown, and so on. In the case reports, this is used to provide the reason for missing data. Thus, use this in search to find cases with missing data for certain fields and a specific reason.

You can find the details of the available null flavor options and their codes in Appendix A. Null flavor specification.

SEARCH

Select to retrieve the list of files satisfying the applied filters.

RESET

Select to clear all the entered filter values and start fresh.

SAVE

Select to save and use the saved filter set when needed.

CANCEL

Select to discard the search and return to the E2B R3 import list.