The Council for International Organizations of Medical Sciences (CIOMS) form is a format for viewing the adverse event information. CIOMS form is used to report the suspected unexpected serious adverse reactions (SUSARs) to the regulatory authorities.
In ESM, you can view, save and print the safety reports in CIOMS format on the Import Section page, Export Section page and Reports: Transaction page.
Note: CIOMS Form view is not applicable for the Medical Device Reports (MDRs) displayed on the eMDR(R2) tab.
A sample of the ICSR file in the CIOMS Report view:
CIOMS Report View