Signal Validation Without EMA Form

Validate a signal using internal methodology equivalent to EMA expectations.

Role: PV Physician

Context: A disproportionality run flagged drug X and hepatic failure. You need to validate the signal. Your company does not use the formal EMA signal validation form.

Task: Produce a validation that would satisfy an inspector.

Step 1 of 2

Validation Content

case

You are writing the internal signal validation report. What must it include to be equivalent to EMA expectations?

Which set is essential?