Vault Safety 19R3 introduced the first version of the FDA and EMA reporting rule sets.

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

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

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

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

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*