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Send email on ICSR

In PV, you can send email notifications on various ICSR-related events directly from the system. This feature is useful for the staff of EDETEK or another external company that acts as a Contract Research Organization (CRO). The emailing functionality provides an opportunity to notify external parties or request them to perform some review and approval actions at different stages of case processing.

Since all the ICSRs in the system must follow a certain case-processing workflow, email templates are preconfigured for all its events (stages). The following schema depicts how certain events correlate with existing email templates.

­Email templates for ICSR events
Figure 1. ­Email templates for ICSR events

The workflow status of the ICSR is directly related to its respective template as shown in the following table.

ICSR workflow status

Template name

Draft

SAE Form for Signature

Data Entry

SAE Notification

Final Review

Draft CIOMS and MedWatch for Review and Approval

Case Submission

Final Submission Package

Important

The following preconditions must be met otherwise, the email templates are unavailable:

  • The ICSR type must be Report from study.

  • The case classification must be one of the following: Expedited/SUSAR or Non-Expedited/SAE.

To send an email on ICSR

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

    Accessing ICSR list
    Figure 2. Accessing ICSR list

  2. On the ICSR List page that opens, in the table, locate the ICSR record for which you need to send an email. 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 page that opens, from the toolbar, select More more_icon.png > Send Email send_email_icon.png.

    Accessing email option
    Figure 4. Accessing email option

  4. At the Select Template stage, choose the template that suits your business needs and the language in which you want to generate the email contents. Then select next_step_button_red_white.png.

    Selecting email template and language
    Figure 5. Selecting email template and language

    Important

    The templates available are preconfigured by the EDETEK administrator in the languages requested by the sponsor. Templates are designed to suit each stage of your ICSR workflow—data entry, case submission, and so on. You can only see the templates relevant to the current stage of ICSR processing.

  5. At the Review stage, you can review and amend the details and content of the email preconfigured according to the selected template. The details of editable elements are provided in the following table.

    Previewing and editing email content
    Figure 6. Previewing and editing email content

    Element

    Details

    Request Delivery Receipt

    Select this checkbox if you want to receive a confirmation letter once the email is delivered to its recipient(s).

    Request Read Receipt

    Select this checkbox if you want to receive a confirmation letter once the email is read by its recipient(s).

    Priority

    Select the option button to establish the level of your email importance—Low, Normal, or High.

    From

    Represents the system-configured email address from which your email is sent. This address cannot be manually edited.

    To

    Represents the email address of the recipient(s). These are system-filled based on the case reporter's details specified in the Reporter form of the ICSR.

    However, you can edit the recipient address, add more, or remove the redundant ones.

    CC

    Represents the additional address to which the email copy is forwarded. These are system-filled based on the logic configured by the EDETEK administrator.

    However, you can edit the copy recipient address, add more, or remove the redundant ones.

    Subject

    Represents the subject of the letter depending on the selected email template. The subject can be edited to suit your business needs.

    Attachments

    Represents the files pulled from the Source form if there are any.

    Select Upload File upload_icon.png to provide attached documents along with your email if needed.

    Content

    Represents the content of the letter depending on the selected email template. The details such as the name of the recipient, sponsor, study, arm, and so on are pulled from various case forms.

    The content can be edited to suit your business needs.

    SEND

    Select send_button_red.png to forward your email to the specified recipients.

    PREVIOUS

    Select previous_icon_.png to return to the template selection step if needed.

    Full Screen

    Select full_screen_icon.png to open the email editor in full-screen view.

    To collapse the full-screen view, select Full Screen Exit full_screen_exit_icon.png.

Once sent, the email is forwarded to its recipients.

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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.