**Source URL:** https://safety.veevavault.help/en/lr/1022564/index.md # Create an ICSR Transmission While Vault creates ICSR _Transmissions_ based on configured reporting rules, you can manually create a _Transmission_ for ad-hoc reporting, such as amendments or nullifications. ## Prerequisite You must have permissions to manage _Transmission_ object records. Typically, these permissions are reserved for _Distribution Manager_ users. ## Create an ICSR Transmission To create an ICSR _Transmission_ for a _Case_: 1. Navigate to the _Case_, expand the **Transmissions** section, and then select **Create**. 2. In the **Create Transmission** window, select the required ICSR _Transmission_ type, and then select **Continue**. 3. Complete the applicable [fields][1]. 4. Select **Save**. ## Transmission Fields {#fields} In addition to the standard _Transmission_ fields, Vault includes fields for review of [late transmissions][2]. The following _Transmission_ fields may be available:
Field Description Transmission Types
Case Vault populates a link to the Case. Submissions, Distributions, Early Notifications
Transmission Profile Select the Transmission Profile configured for sending ICSRs to the destination agency. Depending on your Admin's configuration, selecting the Transmission Profile populates the following fields:
  • Origin
  • Destination
  • Outbound Format
  • Additional Output Formats
  • Sender User
  • Message Subject (including tokens)
  • Message Body (including tokens)
  • Cover Letter Template
  • Vault Clinical (Distributions only)
 Submissions, Distributions, Early Notifications
Origin Select the organization that your Admin has set up as Vault Customer for your Vault. Submissions, Distributions, Early Notifications
Destination Select the destination for the ICSR. Submissions, Distributions, Early Notifications
Transmission Document Type

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.

 Submissions, Distributions, Early Notifications
Additional Transmission Document Type(s) If required, select additional ICSR document formats to generate for the Transmission. Submissions, Distributions, Early Notifications
Sender (User)

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.

 Submissions, Distributions, Early Notifications
File Vault populates a link to the generated transmission document. Submissions, Distributions, Early Notifications
Due Date

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.

 Submissions, Distributions, Early Notifications
Transmission Date

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.

 Submissions, Distributions, Early Notifications
Reason

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
 Submissions, Distributions, Early Notifications
E2B Message ID When the transmission is created (either manually or by the Submit to Gateway action) Vault populates this field with a message ID to use in the E2B message header. Submissions, Distributions, Early Notifications
Organization Vault populates this field when you create a Transmission from a Case. Submissions, Distributions, Early Notifications
Destination Case ID Vault populates this field upon receipt of the final acknowledgment (ACK) when you export E2B transmissions. Submissions, Distributions, Early Notifications
FDA Report Type

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.

 Submissions, Distributions, Early Notifications
Local Expedited Criteria

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.

 Submissions, Distributions, Early Notifications
Validation Status

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 & Submission Validation.

 Submissions, Distributions, Early Notifications
Patient Content Protection

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

 Submissions, Distributions, Early Notifications
Exceptions to Patient Content Protection

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

 Submissions, Distributions, Early Notifications
Study Content Protection To protect unblinded study data in Transmissions, select Mask Unblinded Content. Submissions, Distributions, Early Notifications
Report Type Override

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.

 Submissions, Distributions, Early Notifications
ACK Accepted / Email Date Vault populates the date the transmission enters the Sent or ACK Accepted state. If blank, Vault populates the date the transmission enters the Completed state. Submissions, Distributions
Late Transmission If the ACK Accepted / Email Date is later than the Due Date, Vault populates Yes. If earlier than or equal to the Due Date, Vault populates No. Submissions, Distributions
Case Product Select the Case Product. You must populate a value to generate the following report formats: Submissions, Distributions
Transmission Completed Date

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.

 Submissions, Distributions, Early Notifications
Transmission Sent Date

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.

 Submissions, Distributions, Early Notifications
Auto-Submit

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

 Submissions, Distributions, Early Notifications
Transmission Document Status During document generation, Vault populates Generating. Upon completion, Vault clears this field. Submissions, Distributions, Early Notifications
Reason Text For nullification and amendments only, enter more information about the submission reason. Vault may populate the Transmission Reason Text value from the Case.
Submissions, Distributions, Early Notifications
Downgraded

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
 Submissions, Distributions, Early Notifications
Follow-up Number

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.

 Submissions, Distributions, Early Notifications
Safety Report Version

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.

 Submissions, Distributions, Early Notifications
Message Type (HC)

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.
 Submissions, Early Notifications
Transmission Output Template For rule-engine-created Transmissions created from Transmission Output Templates, Vault populates Yes. Submissions, Distributions, Early Notifications
Approval Due in Days

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.

Submissions, Distributions, Early Notifications
## Late Transmission Review {#late-review} To support investigations into late transmissions, use the _Late Transmission Review_ page together with _Late Case Investigations_. If the equivalent fields on the _Investigation_ page of the _Late Case Investigation_ include values, Vault maps the values to these fields. The following fields may be available on _Submissions_ and _Distributions_: * **Late Assessment**: Select an assessment of whether the _Transmission_ was late. * **Late Assessment Details**: Enter details to describe the _Late Assessment_. * **Late Reason**: Select the reason the _Transmission_ was late. * **Late Status**: Select the status of the _Transmission_. ## Destination-Specific Document Inclusions {#dest-specific-doc-inclusions} When you create an ICSR _Transmission_, Vault attaches documents and literature articles specific to the reporting destination based on your Admin's configuration of the applicable _Transmission Profile_. You can view the list of attachments in the _Destination Specific Document Inclusions_ section of the _Transmission_. ## Next Steps to Complete the Transmission Once you have created the ICSR _Transmission_, you can proceed with one of the following transmission methods, depending on the type of _Transmission Profile_ being used: * Send a Gateway Transmission * Send an Email Transmission * Send to your Clinical Operations Vault (_Distributions_ only) * Track a Manual Transmission ## Withdraw an ICSR Transmission In Safety's out-of-box configuration, all ICSR _Transmissions_ linked to a _Case_ must be in the _Completed_ state before you can close the associated _Case_. If an ICSR _Transmission_ was created in error or must be removed for another reason, you can select **Withdraw Record** from the **All Actions** menu of the _Transmission_. A _Distribution Manager_ can then close the Case. [1]: #fields [2]: #late-review