CIOMS Form
The standardized international form used to report suspected serious adverse reactions to regulators.
What it means
The CIOMS I form is the industry-standard structured template for expedited safety reporting of SUSARs. LATAM regulators accept CIOMS submissions but require the narrative and reaction terms in the local official language, matching MedDRA LLTs.
Why it matters for LATAM submissions
Safety reports move on tight clocks. A translation delay on the narrative can push a submission past the 7- or 15-day deadline and become a GCP finding.
Relevant regulators
ANVISACOFEPRISANMATINVIMADIGEMIDARCSAISPMINSA
Related terms
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