Vault Safety can export Cases to fully compliant and submittable regulatory reports.
Note: Depending on your Admin’s configuration, object, field, and section labels, lifecycle states, and workflows may differ from the general information on this page. Refer to your organization’s business processes for guidance.
Report Generation Overview
Vault Safety maps Case data to generate Individual Case Safety Reports (ICSRs) that are 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. For E2B reports in XML format, you can generate readable renditions for document review.
Transmissions for Clinical Trial Study Cases
When generating Transmissions, if your Admin has enabled Agency-Based Auto-Expectedness for Clinical Trial Study Cases, Vault generates the report using the Expectedness record with a Based On setting that matches the Agency’s setting. For example, if an Agency record is set to base expectedness evaluations on the New Info Date on Cases, Vault generates the report using the Expectedness records where the Based On field is set to “New Info Date”.
If an Agency record does not specify an evaluation basis or is set to “Onset Date”, Vault generates the report using Expectedness records where the Based On field value is “Onset Date”.
If your Admin has not enabled Agency-Based Auto-Expectedness for Clinical Trial Studies, Vault calculates all Expectedness records based on Onset date and generates reports accordingly.
For more information on how Vault evaluates expectedness for Clinical Trial Study Cases, see How Case Assessment Expectedness is Generated.
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. | |
| EU Convention E2B(R2) | Generates an E2B(R2) file compliant with EU convention regional guidelines required for agencies such as Swissmedic and the Therapeutic Goods Administration (TGA) of Australia. | |
| 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. | |
| FDA E2B(R3) | Generates an E2B(R3) file for electronic submissions to the U.S. Food and Drug Administration (FDA) gateway. | |
| PMDA E2B(R3) | Generates an E2B(R3) file for electronic submissions to the Japan Pharmaceuticals and Medical Devices Agency (PMDA) gateway. | |
| MFDS E2B(R3) | Generates an E2B(R3) file for electronic submissions to the Republic of Korea's Ministry of Food and Drug Safety (MFDS) 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 generates a regulatory report in the appropriate format, determined by the associated Transmission Profile.
When a Distribution record for a Partner Distribution Family or Reporting Obligation is created, Vault Safety 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 in 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 Admin may have configured your Vault differently.
Note: Reports generated from the Case page are intended to be used as previews and are 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 you want to generate. The options available depend on your Admin’s configuration. The following options are available by default in most Vaults:
- Generate Preview: CIOMS I: Generates a CIOMS I Suspect Adverse Reaction Report.
- Generate Preview: E2B(R3): Generates an ICH E2B(R3) file.
- Generate Preview: MedWatch (3500A): Generates an FDA MedWatch 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.
Note: Your Admin can configure actions to generate forms in other E2B formats.
Blind-Protection on Report Previews
For blinded Study Cases, people without 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 your Admin. Dosage Masking for Study Products provides more information.
See the following table for details on which regulatory report previews are generated based on blinding setup on Studies, Cases, and Study Arms:
| Study Blinding Setup | Case Blind Protection Setup | Study Arm Setup | Regulatory Report Previews Generated |
|---|---|---|---|
| Blinded | Not blinded | Blinded | Masked only |
| Blinded | Not blinded | Unarmed | Masked only |
| Blinded | Not blinded | Open | Unmasked only |
| Blinded | Blinded | N/A | Masked and unmasked |
| Not blinded | N/A | N/A | Unmasked only |
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.
Note: Vault Safety does not support the .wpd file format for E2B(R3) export.
For Cases and Localized Cases linked to Literature Articles in your SafetyDocs Vault, Vault populates records for the related literature documents in the Documents section.
Vault handles attachment transmissions differently for E2B(R2) and (R3). The following list provides more information:
- E2B(R2) Transmissions: For E2B(R2) formats, attachments and literature documents are encoded directly in the E2B file if the Literature Documents field value on the Transmission is Include. Vault adds all literature references to a single A.2.2 Literature Reference(s) block on the submission.
- E2B(R3) Transmissions: For E2B(R3) formats, attachments and literature documents are encoded directly in the E2B file if the Literature Documents field value on the Transmission is Include. Vault adds each literature reference to a separate C.4.r.1 Literature Reference(s) block on the submission.
- FDA E2B(R2) Transmissions: For FDA E2B(R2) gateway transmissions, Vault 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 works with FDA gateway transmissions, but not with configurable (custom) synchronous gateways.
You must verify that E2B transmission 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 Case field must link to the Case for which the E2B is being generated.
- The Organization field must link to the same Organization as the Case.
- The document must be classified with the Case > Source > Attachment document type.
- The Retransmit field must be set to Yes.
- To populate the E2B Documents Held by Sender (A.1.8.2/C.1.6.1.r.1) data element, complete the Description and Description(continue) fields. In E2B(R3), attachment descriptions are always exported regardless of the Retransmit field value.
- For Cases with over-the-counter (OTC) drugs, to attach OTC carton images to FDA E2B(R2) Transmissions being sent through an AS2 Connection, you must also set the Attachment Type field to FDA Carton Attachment.
Literature Attachments
To retransmit literature attachments populated on Cases linked to Literature Articles, your Admin must enable Literature E2B Retransmission. To attach a literature reference document (A.2.2/C.4.r.1-2), the Vault document fields must be completed as follows:
- The Case field must link to the Case for which the E2B is being generated.
- The Organization field must link to the same Organization as the Case.
- The document must be classified with any of the following document types:
- Case > Source > Literature
- Literature > Literature Article > Full-Text
- Literature > Literature Article > Summary
- To populate the E2B Literature Reference(s) (A.2.2/C.4.r.1) data element, complete the Reference field. References are always exported regardless of the Retransmit field value.
- To export the document content to the Included Documents (C.4.r.2) data element, you must set the Retransmit field to Yes.
Exclude Attachments and Literature Documents
You can choose whether E2B(R3) files will include or exclude attachments and literature documents. To use this feature, your Admin must first enable Excluding Attachments and Literature Documents.
To exclude attachments during Transmission creation, set the Attachments Documents and Literature Documents fields to Exclude as needed. Vault excludes all documents with Retransmit field values of No.
Note: When the Transmission Document Type field is set to E2B(R2), the picklist options are available only when the Destination field is set to FDA.
Case Access Groups
When Transmission documents, Case Attachments, and Literature References are generated, the system populates the Case Access Group field on the document. The Case Access Group is inherited from the associated Case and is read-only.
To view the Case Access Group for a document, go to the Document Information pane, expand the Case Information section, and check the Case Access Group field.
Note: For the Case Access Group field to appear, your Admin must enable Case Access Group Security.