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, Vault generates reports using the Case Assessment Expectedness record with a Based On setting that matches the Agency’s setting. For more information, see Expectedness Evaluations for Clinical Trial Study Cases.
Supported ICSR Report Formats
Vault Safety supports generating the following ICSR formats:
- PDF Form:
- CIOMS I: Generates the CIOMS I form.
- FDA 3500A: Generates the FDA MedWatch 3500A form.
- PMDA MHLW Paper Form: Generates the standard PMDA MHLW Paper Form forms based on the PMDA Reporting Category on the Local Reporting Details record of the Japan Localized Case.
- E2B(R2) XML:
- 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.
- 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.
- ICH E2B(R2): Generates an E2B(R2) file compliant with the ICH common standard guidelines.
- E2B(R3) XML:
- 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 E2B(R3): Generates an E2B(R3) file for electronic submissions to the U.S. Food and Drug Administration (FDA) 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.
- ICH E2B(R3): Generates an E2B(R3) file compliant with the ICH common standard guidelines.
- 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.
- NMPA E2B(R3): Generates an E2B(R3) file for electronic submissions to the China National Medical Products Administration (NMPA) gateway.
- PMDA E2B(R3): Generates an E2B(R3) file for electronic submissions to the Japan Pharmaceuticals and Medical Devices Agency (PMDA) gateway.
The links in the above list provide information on how Vault 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
Vault 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.
PMDA MHLW Paper Form Requirements
To generate a Transmission using a PMDA MHLW Paper Form report type, a Localized Case must include:
- Japanese (Japan) in the Localization field
- A value in the PMDA Reporting Category field of the Local Reporting Details record
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. Vault 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 Document Attachments and Literature References
Learn now Vault attaches documents to E2B transmissions.
Case Access Groups
When Transmission documents, Case Attachments, and Literature References are generated, Vault 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.