Skip to main content

Case note for ICSR

A case note is a comment added by the PV user to a specific data element of an ICSR for another user's attention. The case notes functionality eliminates back-and-forth communication between different specialists working on the same report version and provides a controlled and traceable interaction tool.

For instance, by adding a case note, you can rationalize and explain some data provided by you in the report and save time for the subsequent users and reviewers on investigating the reasoning behind that data piece.

In PV, you can add a case note at any point during the case processing—data entry, quality and medical reviews, submission, or else.

Important

You can create and manage case notes for the cases based on the study access permissions granted to you via ADMIN.

View ICSR case notes

A case note is a comment added by the PV user to a specific data element of an ICSR for another user's attention. The case notes functionality eliminates back-and-forth communication between different specialists working on the same report version and provides a controlled and traceable interaction tool.

In PV, you can add a case note at any point during the case processing—data entry, quality and medical reviews, submission, or else. There are two ways to view the previously added case notes of the same ICSR version:

To view the ICSR case notes under the ICSR processing page

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

  2. On the ICSR List page that opens, in the table, locate the ICSR record of your interest. Then select its case number to open the details page in the new browser tab.

    Alternatively, from the Actions column next to your ICSR, select Edit pencil_icon.png to open the ICSR details in the same browser tab.

    Selecting to edit ICSR
    Figure 1. Selecting to edit ICSR

  3. On the ICSR processing page, from the toolbar, select Case Notes case_notes_icon.png and in the panel that expands, view the list of all the case notes created for this report version. You can expand any case note for more details.

    Viewing case notes list for ICSR
    Figure 2. Viewing case notes list for ICSR

You have viewed the previously added case notes for an ICSR.

To view the ICSR case notes in the contact log

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

  2. On the ICSR List page that opens, in the table, locate the ICSR record of your interest. Then select its case number to open the details page in the new browser tab.

    Alternatively, from the Actions column next to your ICSR, select Edit pencil_icon.png to open the ICSR details in the same browser tab.

    Selecting to edit ICSR
    Figure 3. Selecting to edit ICSR

  3. On the ICSR report page, from the toolbar, select Contact Log contact_log_icon.png.

    Opening contact log
    Figure 4. Opening contact log

  4. On the Contact Log page, view the case notes created for your ICSR case version.

    Viewing case notes in contact log
    Figure 5. Viewing case notes in contact log

You have viewed the previously added case notes for an ICSR via the contact log.

Add new case note

A case note is a comment added by the PV user to a specific data element of an ICSR for another user's attention. The case notes functionality eliminates back-and-forth communication between different specialists working on the same report version and provides a controlled and traceable interaction tool.

In PV, you can add a case note at any point during the case processing—data entry, quality and medical reviews, submission, or else.

Important

The case notes added for a specific ICSR version are available only for this version. If there is a follow-up version, the case notes added for the previous one are not available when processing the follow-up.

There are two ways to add a case note to an ICSR:

To add a case note directly from the ICSR processing page

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

  2. On the ICSR List page that opens, in the table, locate the ICSR for which you need to add a case note. Then select its case number to open the details page in the new browser tab.

    Alternatively, from the Actions column next to your ICSR, select Edit pencil_icon.png to open the ICSR details in the same browser tab.

    Selecting to edit ICSR
    Figure 1. Selecting to edit ICSR

  3. On the ICSR processing page, from the toolbar, select Case Notes case_notes_icon.png and in the panel that expands, select New add_new_icon.png.

    Adding new case note in ICSR
    Figure 2. Adding new case note in ICSR

  4. In the New form that appears, complete the details as explained in the following table.

    Completing case note details
    Figure 3. Completing case note details

    Tip

    In the following table, mandatory elements are marked with an asterisk (*).

    Element

    Details

    Type*

    Select the current status of the case for which you are adding a case note, for instance, Draft, Data Entry, Medical Review, or else.

    Description*

    Enter the description of your case note providing all the relevant details to make it clear for the subsequent user.

    SAVE

    Select save_button_red_white.png to save the implemented changes.

    CANCEL

    Select cancel_button.png to discard the changes without saving.

    Tip

    To facilitate the entering of longer text, expand the Description dialog by selecting Maximize max_icon.png.

    Maximizing description text field
    Figure 4. Maximizing description text field

Upon saving, the case note is added to the ICSR version and can be viewed by other users.

To add a case note from the contact log

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

  2. On the ICSR List page that opens, in the table, locate the ICSR for which you need to add a case note. Then select its case number to open the details page in the new browser tab.

    Alternatively, from the Actions column next to your ICSR, select Edit pencil_icon.png to open the ICSR details in the same browser tab.

    Selecting to edit ICSR
    Figure 5. Selecting to edit ICSR

  3. On the ICSR report page, from the toolbar, select Contact Log contact_log_icon.png.

    Opening contact log
    Figure 6. Opening contact log

  4. On the Contact Log page, from the workspace toolbar, select New Case Note case_notes_icon_2.png, and in the dialog that opens, complete the details as explained in the respective table.

    Adding case note
    Figure 7. Adding case note

  5. Select save_button_red_white.png to save the implemented changes.

Upon saving, the case note is added to the ICSR version and can be viewed by other users.

Edit case note

A case note is a comment added by the PV user to a specific data element of an ICSR for another user's attention. The case notes functionality eliminates back-and-forth communication between different specialists working on the same report version and provides a controlled and traceable interaction tool.

In PV, you can add a case note at any point during the case processing—data entry, quality and medical reviews, submission, or else. Sometimes, you might need to edit your case note description or change its type.

There are two ways to edit a case note:

To edit a case note directly from the ICSR processing page

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

  2. On the ICSR List page that opens, in the table, locate the ICSR for which you need to edit a case note. Then select its case number to open the details page in the new browser tab.

    Alternatively, from the Actions column next to your ICSR, select Edit pencil_icon.png to open the ICSR details in the same browser tab.

    Selecting to edit ICSR
    Figure 1. Selecting to edit ICSR

  3. On the ICSR processing page, from the workspace toolbar, select Case Notes case_notes_icon.png and in the panel that expands, select the case note that you need to edit.

  4. In the form that expands, edit the case note details as explained in the respective table and select save_button_red_white.png.

    Editing case note
    Figure 2. Editing case note

Upon saving, the case note is updated.

To edit a case note from the contact log

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

  2. On the ICSR List page that opens, in the table, locate the ICSR for which you need to edit a case note. Then select its case number to open the details page in the new browser tab.

    Alternatively, from the Actions column next to your ICSR, select Edit pencil_icon.png to open the ICSR details in the same browser tab.

    Selecting to edit ICSR
    Figure 3. Selecting to edit ICSR

  3. On the ICSR report page, from the toolbar, select Contact Log contact_log_icon.png.

    Opening contact log
    Figure 4. Opening contact log

  4. On the Contact Log page, go to the case note you need to edit and from the Actions column, select Edit pencil_icon.png.

    Selecting case note to edit
    Figure 5. Selecting case note to edit

  5. In the Edit Case Note dialog that opens, edit the details as explained in the respective table.

    Editing case note details
    Figure 6. Editing case note details

  6. Select save_button_red_white.png to save the implemented changes.

Upon saving, the case note is updated.

Delete case note

A case note is a comment added by the PV user to a specific data element of an ICSR for another user's attention. The case notes functionality eliminates back-and-forth communication between different specialists working on the same report version and provides a controlled and traceable interaction tool.

In PV, you can add a case note at any point during the case processing—data entry, quality and medical reviews, submission, or else. You can also delete a case note if it is, for instance, irrelevant.

There are two ways to delete a case note from an ICSR:

To delete a case note via the ICSR processing page

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

  2. On the ICSR List page that opens, in the table, locate the ICSR for which you need to delete a case note. Then select its case number to open the details page in the new browser tab.

    Alternatively, from the Actions column next to your ICSR, select Edit pencil_icon.png to open the ICSR details in the same browser tab.

    Selecting to edit ICSR
    Figure 1. Selecting to edit ICSR

  3. On the ICSR processing page, from the workspace toolbar, select Case Notes case_notes_icon.png and in the panel that expands, view all the case notes created for this report version.

  4. Hover over the case note that you want to remove and select Delete trash_can_icon.png that appears.

    Selecting to delete case note
    Figure 2. Selecting to delete case note

  5. In the confirmation dialog that opens, select delete_button_white_red.png to proceed with deletion.

    Confirming case note deletion
    Figure 3. Confirming case note deletion

Upon confirmation, the case note is removed from your ICSR.

To delete a case note via the contact log

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

  2. On the ICSR List page that opens, in the table, locate the ICSR for which you need to delete a case note. Then select its case number to open the details page in the new browser tab.

    Alternatively, from the Actions column next to your ICSR, select Edit pencil_icon.png to open the ICSR details in the same browser tab.

    Selecting to edit ICSR
    Figure 4. Selecting to edit ICSR

  3. On the ICSR report page, from the toolbar, select Contact Log contact_log_icon.png.

    Opening contact log
    Figure 5. Opening contact log

  4. On the Contact Log page, go to the case note you want to remove and from the Actions column next to it, select Delete trash_can_icon.png.

    Selecting to delete case note
    Figure 6. Selecting to delete case note

  5. In the confirmation dialog that opens, select delete_button_white_red.png to proceed with deletion.

    Confirming case note deletion
    Figure 7. Confirming case note deletion

Upon confirmation, the case note is removed from your ICSR.

View case note change history

A case note is a comment added by the PV user to a specific data element of an ICSR for another user's attention. The case notes functionality eliminates back-and-forth communication between different specialists working on the same report version and provides a controlled and traceable interaction tool.

Every time you introduce any changes to case notes, these changes are recorded by the system. Then you can view the list of all actions done with any case note in a separate dialog.

To view the case note change history

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

  2. On the ICSR List page that opens, in the table, locate the ICSR of your interest. Then select its case number to open the details page in the new browser tab.

    Alternatively, from the Actions column next to your ICSR, select Edit pencil_icon.png to open the ICSR details in the same browser tab.

    Selecting to edit ICSR
    Figure 1. Selecting to edit ICSR

  3. On the ICSR report page, from the workspace toolbar, select Contact Log contact_log_icon.png.

    Opening contact log
    Figure 2. Opening contact log

  4. In the Contact Log table that appears, next to the needed case note, select More more_icon.png > Change History history_icon.png.

    Selecting option to view case note change history
    Figure 3. Selecting option to view case note change history

  5. In the Change History dialog that opens, view the complete history of changes made to the selected case note.

    Viewing change history
    Figure 4. Viewing change history

After viewing the history of changes for a case note, select ok_button_red_white.png to close the Change History dialog.

View case note audit trail

A case note is a comment added by the PV user to a specific data element of an ICSR for another user's attention. The case notes functionality eliminates back-and-forth communication between different specialists working on the same report version and provides a controlled and traceable interaction tool.

Every time you introduce any changes to case notes, these changes are recorded by the system. Then you can track the list of all actions done with any case note in a descriptive format in a separate dialog.

To view the case note audit trail

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

  2. On the ICSR List page that opens, in the table, locate the ICSR of your interest. Then select its case number to open the details page in the new browser tab.

    Alternatively, from the Actions column next to your ICSR, select Edit pencil_icon.png to open the ICSR details in the same browser tab.

    Selecting to edit ICSR
    Figure 1. Selecting to edit ICSR

  3. On the ICSR report page, from the workspace toolbar, select Contact Log contact_log_icon.png.

    Opening contact log
    Figure 2. Opening contact log

  4. In the Contact Log table that appears, next to the needed case note, select More more_icon.png > Audit Trail list_icon_gray.png.

    Selecting option to view case note audit trail
    Figure 3. Selecting option to view case note audit trail

  5. In the Audit Trail dialog that opens, view the complete descriptive history of operations performed on a case note.

    Viewing audit trail
    Figure 4. Viewing audit trail

After viewing the audit trail for a case note, select ok_button_red_white.png to close the Audit Trail dialog.

In this section:

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.