Definition

An electronic message from a regulatory authority confirming receipt of an E2B submission and indicating whether it passed validation.

Example

After E2B submission, the company receives ACK1 (receipt confirmation) and ACK2 (validation result). A negative ACK2 indicates errors requiring correction and resubmission.

Regulatory source

ICH E2B(R3), Gateway Standards

Common mistakes

Not monitoring for ACKs or ignoring negative acknowledgments, leading to cases not being properly received by regulators.

Inspector question

How do you track E2B acknowledgments? What is your process when you receive a negative ACK?

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