Sections in This Article
About Reporting Rules in Vault Safety 20R3 and Earlier
The following sections list the reporting rules included in version 1 of the FDA and EMA rule sets. These rules are deprecated and no longer in use. The new rule set versions, introduced in 21R1, include support for more submission scenarios and many other improvements.
FDA ICSR Reporting Rule Set (20R3 and Earlier)
The following sections describe the preconfigured FDA reporting rule set.
FDA Study
When a Study Case that meets the following criteria enters the Approved state, Vault Safety generates a Submission record with the FDA Study Transmission Profile:
- Serious and unexpected primary adverse event
- Suspect or interacting Study Product registered to a country within the FDA’s jurisdiction
- Adverse event relatedness (causality) attributed to the suspect or interacting product
Note An administrator can override reporting rules at the Study-level using the Submission Rule section.
Due dates for FDA study Submissions adhere to the following rules, by default:
Report Format: FDA MedWatch 3500A
| Seriousness | Seriousness Criteria | Expectedness | Relatedness | Case Event Country | Initial Case Due Date | Follow-Up Case Due Date |
|---|---|---|---|---|---|---|
| Serious | Fatal or life-threatening | Unexpected | Causality established by the Company or Reporter's Case Assessment Result | Any | 7 days | 15 days |
| Serious | Non-fatal and non-life-threatening | Unexpected | Causality established by the Company or Reporter's Case Assessment Result | Any | 15 days | 15 days |
Note You may see additional inactive FDA study rule sets in your vault, which are not in use.
FDA Post-Market
When a post-market Case with a suspect or interacting product registered within the FDA’s jurisdiction enters the Approved state, Vault Safety generates a Submission record with the appropriate FDA ESG Transmission Profile, whether CBER or CDER.
Due dates for FDA post-market Submissions adhere to the following rules:
Report Format: FDA E2B (R2)
| Seriousness | Seriousness Criteria | Expectedness | Case Event Country | Initial Case Due Date | Follow-Up Case Due Date |
|---|---|---|---|---|---|
| Serious | Any | Unexpected | Any | 15 days | 15 days |
| Serious | Any | Expected | A country within FDA jurisdiction | 15 days | 15 days |
| Non-serious | N/A | Any | A country within FDA jurisdiction | 30 days | 15 days |
FDA Post-Market Medical Device Reporting
When post-market Cases with a suspect or interacting combination product registered within the FDA’s jurisdiction enters the Approved state, Vault Safety automatically generates Submission records to meet the PSMR regulatory reporting requirements.
For each product constituent, Vault Safety generates a Submission record with the appropriate FDA ESG Transmission Profile, whether CBER or CDER.
Due dates for FDA post-market combination product Submissions adhere to the following rules:
Report Format: FDA E2B (R2)
| Device Report Type | Seriousness | Seriousness Criteria | Expectedness | Initial Case Due Date | Follow-Up Case Due Date |
|---|---|---|---|---|---|
| Public Health Risk | Any | Any | Any | 5 days | 5 days |
| Malfunction-only or Unspecified | Serious | Any | No (Unexpected) | 15 days | 15 days |
| Malfunction-only or Unspecified | Serious | Any | Yes (Expected) | 15 days | 15 days |
| Malfunction-only or Unspecified | Non-Serious | N/A | No (Unexpected) | 30 days | 30 days |
EMA ICSR Reporting Rule Set (20R3 and Earlier)
The following sections describe the preconfigured EMA reporting rule set.
EMA Study
When a Study Case that meets the following criteria enters the Approved state, Vault Safety generates a Submission record with the EVCTM Transmission Profile:
- Serious and unexpected primary adverse event
- Suspect or interacting Study Product registered to a country in the European Union
- Adverse event relatedness (causality) attributed to the suspect or interacting EU product
Note An administrator can override reporting rules at the Study-level using the Submission Rule section.
Due dates for EMA study Submissions adhere to the following rules, by default:
Report Format: EMA E2B (R3)
| Seriousness | Seriousness Criteria | Expectedness | Relatedness | Case Event Country | Initial Case Due Date | Follow-Up Case Due Date |
|---|---|---|---|---|---|---|
| Serious | Fatal or life-threatening | Unexpected | Causality established by the Company or Reporter's Case Assessment Result | Any | 7 days | 15 days |
| Serious | Non-fatal and non-life-threatening | Unexpected | Causality established by the Company or Reporter's Case Assessment Result | Any | 15 days | 15 days |
Note You may see additional inactive EMA study rule sets in your vault, which are not in use.
EMA Post-Market
When a post-market Case with a suspect or interacting Product registered to a country in the European Union enters the Approved state, Vault Safety generates a Submission record with the EVHUMAN Transmission Profile.
Due dates for EMA post-market Submissions adhere to the following rules:
Report Format: EMA E2B (R3)
| Seriousness | Seriousness Criteria | Expectedness | Case Event Country | Initial Case Due Date | Follow-Up Case Due Date |
|---|---|---|---|---|---|
| Serious | Any | Any | Any | 15 days | 15 days |
| Non-serious | N/A | Any | Any country within EMA jurisdiction | 90 days | 15 days* |
Note Usually, both Initial and Follow-Up Submissions for a Non-serious Case can be sent to the EMA within 90 days. The only exception is when a Serious Case becomes a Non-serious Case: the first Follow-Up Case after this change must be sent within 15 days and all subsequent Follow-Up Cases can be sent within 90 days. The Follow-Up Submission rule for non-serious cases in Vault Safety adheres to this exception and sets the Follow-Up Case Submission due date to 15 days.
