Reporting Rule Sets (20R3 and Earlier)

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

Note: An Admin 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 Admin 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.