Sections in This Article
- Report Generation Overview
- Supported ICSR Report Formats
- Automatic Generation of Reports for Transmissions
- Manually Generate a Submittable Report
- Generate a Report Preview from the Case
- E2B Export Size Limits
- E2B Document Attachments and Literature References
Report Generation Overview
Vault Safety maps Case data to generate Individual Case Safety Reports (ICSRs) that are fully compliant, maintain case versions, and support multiple Submission and Distribution destinations.
You can generate regulatory reports automatically as part of the Transmission workflow or manually. You can also preview the Case in a regulatory report format to assist with reviewing and assessing the Case. Generated files appear in the Vault Library and are versioned during regeneration.
Supported ICSR Report Formats
Vault Safety supports generating the following ICSR formats:
| File Type | Format | Description |
|---|---|---|
| PDF Form | FDA 3500A | Generates the FDA MedWatch 3500A form. |
| CIOMS I | Generates the CIOMS I form. | |
| E2B (R2) XML | ICH E2B (R2) | Generates an E2B (R2) file compliant with the ICH common standard guidelines. |
| FDA E2B (R2) | Generates an E2B (R2) file for electronic submissions to the U.S. Food and Drug Administration (FDA) gateway. | |
| HC E2B (R2) | Generates an E2B (R2) file for electronic submissions to Health Canada (HC) gateway. | |
| E2B (R3) XML | ICH E2B (R3) | Generates an E2B (R3) file compliant with the ICH common standard guidelines. |
| EMA E2B (R3) | Generates an E2B (R3) file for electronic submissions to the European Medicines Agency (EMA) and the UK Medicines & Healthcare products Regulatory Agency (MHRA) gateway. | |
| FDA VAERS E2B (R3) | Generates an E2B (R3) file for vaccine-related electronic submissions to the U.S. Food and Drug Administration (FDA) VAERS gateway. |
The links in the above table provide information on how Vault Safety maps case data to generate reports in each of these formats. For more information on which report formats to generate for different regulatory agencies, see the report formats detailed on Standard Agency ICSR Submissions.
Automatic Generation of Reports for Transmissions
When a Submission record to a regulatory agency is created, Vault Safety automatically generates a regulatory report in the appropriate submission format, determined by the associated Transmission Profile.
When a Distribution record for a Partner Distribution Family or Reporting Obligation is created, Vault Safety automatically generates a regulatory report in the format specified on the Distribution record or associated Transmission Profile.
Manually Generate a Submittable Report
You can generate any supported report format from a Submission or Distribution record using the Generate Transmission Document(s) user action.
Note You cannot generate transmission documents for Imported Cases. The Generate Transmission Document(s) user action is visible for these Case types but the action does not generate a document. If you must generate a report, you can convert the Imported Case to a Case or Follow-Up Case.
- Go to the Submission or Distribution record.
- Check that the report type in the Transmission Document Type field is the report that you want to generate.
- To change the report type, select Edit, and then choose a different report in the Transmission Document Type field.
- Expand the All Actions (
) menu, and then select Generate Transmission Document(s).
Result
The system generates the case report document and adds a link to the document to the File field. If you do not see the file, refresh the page.
Note If the transmission document name exceeds 100 characters (the maximum length), the system automatically truncates it to 100 characters so that the transmission document can generate successfully.
Generate a Report Preview from the Case
By default, users assigned the Data Entry, Reviewer, or Medical Reviewer role can generate reports from the Case page. However, your vault may be configured differently.
Note Reports generated from the Case page are intended to be used as previews and not intended for submissions. Generate reports from the Submission or Distribution record for a final version.
- Go to the Case for which you want to generate a regulatory report preview.
- Expand the All Actions () menu, and then select the format for which you want to generate.
The options available depend on your system configuration. The following options are available by default in most vaults:- Generate CIOMS I: Generates a CIOMS I Suspect Adverse Reaction Report.
- Generate E2B R3: Generates a FDA E2B R3 file.
- Generate FDA3500A: Generates a MedWatch FDA 3500A form.
The system generates the report and attaches it to the Case under Documents.
- To view the report, expand Documents, and then select the name of the report.
The Classification column identifies the report type.
Tip Your administrator can configure actions to generate forms in other E2B formats.
Blind-Protection on Report Previews
For blinded Study Cases, users that do not have privileges to view unblinded data can generate regulatory report previews with all unblinded data masked or removed from the generated file.
Note Study Product dosage is unblinded on report previews if dosage blinding has not been enabled by Veeva Support in your Vault. Dosage Masking for Study Products provides more information.
When you generate a regulatory report preview on a blinded Case, Vault Safety generates two separate documents. One document contains the unblinded data and is only visible to users authorized to access unblinded data. The second document masks all unblinded data and is prefixed with Blinded in the filename.
Note To generate blinded regulatory report previews, the Case Product selected must be a blinded Study Product.
E2B Export Size Limits
For EMA E2B submissions, attachment file size cannot exceed 15 MB. All Vault Safety E2B transmissions have a maximum total size limit of 100 MB.
E2B Document Attachments and Literature References
Case documents that meet the appropriate criteria are included with E2B transmissions. Add a Case Attachment or Literature Document provides more information on adding these documents to a Case.
The system handles attachment transmissions differently for E2B R2 and R3. The following list provides more information:
- E2B R3 Transmissions: For E2B (R3) formats, attachments and literature documents are encoded directly in the E2B file.
- FDA E2B R2 Transmissions: For FDA E2B (R2) gateway transmissions, the system sends attachments separately after receiving an acknowledgment (ACK) acceptance from the health authority for the ICSR E2B transmission. Once sent, each attachment receives its own ACK.
Note The E2B R2 attachment feature only works with FDA gateway transmissions, not with configurable (custom) synchronous gateways.
You must verify that E2B transmision attachments are supported by the destination gateway. The following list provides links with more information on verification with various destination gateways:
- International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
- European Medicines Agency (EMA)
- Food and Drug Administration Vaccine Adverse Event Reporting System (FDA VAERS)
- Medicines and Healthcare Products Regulatory Agency (MHRA)
Document Attachments
To attach a document (A.1.8.1/C.1.6.1.r.2), the vault document fields must be completed as follows:
- The document's Case field must link to the Case for which the E2B is being generated.
- The Organization field must link to the same Organization with which the Case is linked.
- The document must be classified with the Case > Source > Attachment document type.
- The Retransmit field set to Yes.
- To populate E2B Documents Held by Sender (A.1.8.2/C.1.6.1.r.1), complete the Attachment Description and Attachment Description Continued fields. In E2B(R3), attachment descriptions are always exported regardless of the Retransmit field value.
Literature Attachments
To attach a literature reference document (A.2.2/C.4.r.1-2), the vault document fields must be completed as follows:
- The document's Case field must link to the Case for which the E2B is being generated.
- The Organization field must link to the same Organization with which the Case is linked.
- The document must be classified with the Case > Source > Literature document type.
- To populate E2B Literature Reference(s) (A.2.2/C.4.r.1), complete the Reference field. References are always exported regardless of the Retransmit field value.
- To export the document content (C.4.r.2), you must set the Retransmit field to Yes.
Exclude Attachments and Literature Documents
An administrator can configure attachments and literature references to exclude them from E2B(R3) files by performing the steps in Enable Excluding Attachments and Literature Documents.
After this feature has been configured, you can then choose to exclude or include these documents in the E2B(R3) file, while considering the destination of the Transmission.
- For Literature Documents, go to the respective Transmission and select the Exclude picklist option for Literature Documents.
- After an administrator performs the enablement, Attachment Documents are excluded by default. To include attachments, you must:
- Set the Retransmit field to Yes on the document.
- Select the Include picklist option for the Attachment Documents field on the Transmission.
Note that for E2B(R2) Transmissions, the picklist option is only available when the destination is FDA.
