Capturing Local Data Entry

Application supports Local Data Entry (LDE) for updating the LDE tags, before submitting the case to the authorities or partners.

Note: Application support LDE for only the AER cases (ICSRs) distributed in E2B (R2) and E2B (R3) formats.

The local affiliate has an option to edit a case for narrative include clinical, sender comments, and causality LDE tags, before submitting the case to the authority. After approving the case for submission, the application regenerates the ICSR file for the latest changes that is reflected on the Approved LDE page.

Note: On the Local Data Entry page, you can enter or modify the sender comment and event description only if you have access privilege for local data entry. The access privilege for the local data entry is set in the ARISg Admin (ARISg Admin > Security menu > Roles & Privileges > ESM tab > Operation Privileges section). For more information on setting the ESM roles and privileges, refer the ARISg Administrator's guide.

To view the Local Data Entry:

  1. From the Export listing page > E2B (R2) or E2B (R3) tab, click .
    The local Data Entry page appears.

Note: On the Local Data Entry page, you can enter or modify the sender comment and event description for a case only if you have access privilege for local data entry and Narrativeincludeclinical and Sendercomment tags are assigned to the receiver of the case.
The access privilege for the local data entry is set in the ARISg Admin (ARISg Admin > Security menu > Roles & Privileges > ESM tab > Operation Privileges section).
The local data entry tags are assigned to the receiver on the ARISg admin Local Data Entry page (ARISg Admin > ESM menu > Local Data Entry). For more information on setting the ESM roles and privileges, refer the ARISg Administrator's guide.

  1. Refer the following field description table to perform various tasks related to local data entry on the local Data Entry page:

Local Data Entry Field Description Table

Field

Description

Local Data Entry

Message Number

The message number associated to the case.

The message number is a reference for the corresponding AER number and the Safety report.

AER Number

The unique AER number that the ARISg generates automatically or user enters manually.

Distribution Language

The language specified for a partner who has the LDE privilege.

Note: You cannot change the language in this field, as the language is specific to a partner and configured at ARISg distribution level.

Sender's Comments (B.5.4)

View the detailed assessment information that the sender has entered for the current case. You also can add more details to the existing information or overwrite the existing information.

In the corresponding Language filed, you can view the language specific to the sender comments.

Event description (B.5.1)

The detailed description for the adverse event of the case. You can append or overwrite the existing description.

In the corresponding Language filed, you can view the language specific to event description.

  1. Click Save.
    The data is modified in the database without regeneration of the ICSR file.

  2. Click Approve to approve the local data entry Tags and regenerate the ICSR file.

To view the Local Data Entry (LDE) for E2B (R3):

  1. From the Export listing page > E2B (R3), click  for the case for which you want view the LDE.
    The Local Data Entry page appears.

    Note: On the Local Data Entry page, you can enter or modify only the case summary and reporter comments.

  2. Refer the following field description table to perform various tasks related to local data entry on the Local Data Entry page:

    Local Data Entry Field Description Table

    Field

    Description

    Local Data Entry

    Message Number

    The message number associated to the case. The message number is a reference for the corresponding AER number and the Safety report.

    Recipient language

    The language specified for a recipient having the LDE privilege.

    Note: You cannot change the language in this field, as the language is specific to a recipient and is configured at ARISg distribution level.

    AER Number

    The unique AER number that the ARISg generates automatically or the user should enter manually.

    H.1 Case Narrative

    View the case narrative for the H.1 tag.

    H.2 Reporter’s  Comments

    View the reporter’s comments for the H.2 tag.

    H.4 Sender Comments

    View the sender’s comments for the H.4 tag.

    Note: You cannot modify the data in H.1, H.2 and H.4 fields, since they are display fields.

    H.5.r Case Summary and Reporter Comments

    View the Case Summary and Reporter Comments for the case in recipient language. You can add or modify the details by referring the read only details displayed in recipient language in H.1, H.2 and H.4 sections. The details cannot exceed 1,00,000 AN characters.

    Note: You cannot enter the details in H.5 block in English or any other language other than recipient’s language.

  3. Click  to open Expand view of the Case Summary and Reporter Comments. In the expanded view window click  to get back to the LDE window.

  4. Click to delete the data in H.5.r Case Summary and Reporter Comments section.

  5. Use  to navigate across all the listing pages.

  6. Click Save.
    The data is modified in the database without regeneration of the ICSR file.

  7. Click Approve to approve the local data entry Tags and regenerate the ICSR file.