Definition

A standardized one-page form developed by the Council for International Organizations of Medical Sciences for reporting individual adverse reactions.

Example

Before electronic E2B submissions became standard, the CIOMS I form was the international standard for paper-based expedited adverse reaction reporting.

Regulatory source

CIOMS, Historical Standard

Common mistakes

Using CIOMS forms when E2B electronic submission is required. Most major regulators now require electronic submission.

Inspector question

When, if ever, do you still use CIOMS forms? What is your backup procedure if electronic submission fails?

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