Definition

The process of voiding a previously submitted ICSR, typically when it is determined to be a duplicate or invalid.

Example

After submission, it's discovered that Case A and Case B are duplicates of the same event. Case B is nullified with reference to Case A as the master record.

Regulatory source

ICH E2B(R3), EU GVP Module VI

Common mistakes

Using nullification to correct data errors instead of submitting follow-up reports. Nullification should only be used for truly invalid or duplicate cases.

Inspector question

What criteria must be met to nullify a case? Show me your nullification SOP and recent examples.

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