Definition

A subsequent submission that provides new, additional, or corrected information to a previously submitted ICSR.

Example

After submitting an initial report, the company obtains autopsy results that change the outcome from 'hospitalization' to 'death.' A follow-up report is submitted with this significant new information.

Regulatory source

ICH E2B(R3), ICH E2D

Common mistakes

Submitting follow-up reports for trivial changes. Follow-ups should contain meaningful new information affecting safety assessment.

Inspector question

What criteria do you use to determine if new information warrants a follow-up report submission?

Related terms