Create an ICSR Transmission

• Origin
• Destination
• Outbound Format
• Additional Output Formats
• Sender User
• Message Subject (including tokens)
• Message Body (including tokens)
• Cover Letter Template
• Vault Clinical (Distributions only)

Select the ICSR document format to generate for the Transmission.

For gateway transmissions, select an E2B format. For Submissions, select a report format appropriate for the relevant regulatory agency.

If your Admin has configured the Transmission Profile to populate this field with a default Sender User, Vault populates this field on the Transmission.

If this field is left blank on the Transmission Profile, Vault populates the person assigned the Head of Safety sharing role.

For Submissions, Vault populates this field based on the Case attributes and reporting rule for the jurisdiction.

For Distributions and Early Notifications, if the Transmission is created by a passing reporting rule, Vault populates this field.

The date of transmission. Vault populates the date and time when the Submit to Gateway action is triggered.

This field is required for Submissions to the EMA.

The reason for submitting this ICSR to the destination. Vault may populate this field based on a reporting rule or Case-level value.

If configured by your Admin, if a Case does not have a previous Transmission to a destination, including for follow-ups to imported Cases, Vault populates Initial in this field. Otherwise, when processing a follow-up to an imported Case with no Transmissions, Vault populates Follow-Up.

If Vault does not populate this field, you can select from the following options:

• Initial: For the first submission for the Case
• Amendment: For an amendment to a prior submission for the Case
• Follow-Up: For a follow-up Case
• Nullification: To report a Case as nullified

For manual Submissions using the FDA 3500A form, you can optionally use this field to specify the report type. The value in this field populates the appropriate checkbox in box G.7 Type of Report.

If you don't specify this field, Vault calculates G.7 Type of Report. For more information, see the description on the applicable FDA MedWatch 3500A format.

Whether the Case requires expedited reporting, according to agency-specific criteria. For example, the FDA's local expedited criteria for post-market cases is serious and unexpected.

Vault sets this field after matching the Case to the appropriate reporting rule. You can manually edit this field to override the Vault-set local expedited value.

The calculated Validation Result for the Submission.

The following list describes the Validation Status field values:

• Pass: No validation rule failures were found.
• Warning: At least one validation rule has failed to pass with a Warning status.
• Fail: At least one validation rule has failed to pass with a Fail status.
• Hard Fail: At least one validation rule has failed to pass with a Hard Fail status.

To learn more, see Case and Submission Validation.

To mask patient data in the generated safety report, select a masking option.

To leave certain information unmasked when using Patient Content Protection, select one or more fields to unmask.

When reporting to the EMA, you can override the Report Type. This is useful, for example, when a Clinical Trial Case involves adverse events related solely to non-investigational medicinal products available in the EU.

Select a Report Type from the picklist.

When generating EMA E2B(R3) reports, the C.1.3 Type of Report data element is populated with the corresponding code. This overrides the value in the Report Type field on the Case. Additionally, if Report Type Override is set to Spontaneous, the C.5 Study Identification block is not generated.

• EU MIR
• FDA eMDR
• MHRA MIR XML
• PMDA Form 8
• PMDA Form 10
• PMDA Form 13
• PMDA Form 14

The confirmed date and time the transmission was completed.

For transmissions sent by gateway, enter the date and time that Vault received the final ACK signal.

For manual transmissions, enter the confirmed date and time the transmission was completed.

The confirmed date and time the transmission was sent to the destination.

For transmissions sent by gateway, enter the date and time that Vault received the MDN signal.

For manual transmissions, enter the confirmed date and time the transmission was sent to the destination.

Select Yes to enable automatic transmissions directly from the Case.

Leave this field blank to require users to trigger the submission manually from the ICSR Transmission

Marks Cases that match a downgrade scenario. Vault populates this field after matching the Case to the appropriate reporting rule.

A downgraded Case is a Follow-Up Case that has a preceeding Case version with a Transmission that meets the following conditions:

• The Case is no longer Serious
• The Case Assessments changed to Expected
• The Case Assessment Results changed to Unrelated

For Submissions, Vault populates this field based on the number of previously completed Submissions to the same reporting destination for the Case, including previous Case versions. Prior Submissions must be in the ACK Accepted or Completed state to be counted.

You can manually override the value, however, this field is hidden by default. Your Admin can add this field to the layout, or you can add the field to the grid view on the Submissions tab.

Note the following considerations about the Submission Follow-up Number:

• Vault generates an initial Submission with a Follow-up Number when the initial Case is not a SUSAR or SAE but has a completed Submission, and the Follow-Up Case is upgraded to a SUSAR or SAE.
• Vault generates a follow-up Submission without a Follow-up Number when the initial SUSAR or SAE Case does not have a completed Submission. For example, E2B imported Cases. As a workaround, you can manually change the Reason to Follow-up and set the Follow-up Number to 1.

For Distributions and Early Notifications, enter the follow-up number for follow-ups only.

The version of the safety report. This field populates the <safetyreportversion> tag in E2B(R2) exports. By default, Vault populates this field with the Version from the Case. Your Admin can edit the default value in the field settings. This field has a two-character limit.

For transmissions to Health Canada, you can use this field to select the Message Type (M.1.1) to populate when generating a transmission document in the HC E2B(R2) format.

This picklist contains the following standard options:

• ichicsr: Message type for post-market submissions to the Marketed Health Products Directorate (MHPD)
• cticsr: Message type for clinical trial submissions the Therapeutic Products Directorate (TPD)
• camricsr: Message type for the Canada's Access to Medicines Regime (CAMR)
• sapicsr: Message type for the Special Access Programme (SAP)

This field is set to the following default values when using the standard Health Canada Transmission Profile:

• For the HC MHPD Transmission Profile, this field is set to ichicsr.
• For the HC TPD Transmission Profile, this field is set to cticsr.

When the Safety Rules Engine creates a non-OLT Submission, Vault sets this field of the Submission to the value in the Approval Due in Days rule parameter if one exists, otherwise Vault leaves this field blank. For an OLT Submission, Vault sets this field to the same Approval Due in Days value as the Submission being copied.

If required for manually created Submissions, enter the whole number of days by which the Case must be approved. Otherwise this field is optional for manually created Submissions.