Module232025

07/05/2025

Compliance check

In the request for compliance check template : List the key elements one by one For each key element, justify that it has been done as agreed in PIP, and detail where in the study report it is found Use a new row for each key element Further compliance check information here: Compliance check Q&A document

The Organisation for Professionals in Regulatory Affairs

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Compliance check

All key-binding elements must be fulfilled, otherwise it is noncompliant!!!

Example: Number of study participants: “At least 30” If in this case only 29 patients complete the trial, it will be deemed not compliant by the time of the compliance check

Check your compliance in due time before MAA - in time to do a PIP modification!

The Organisation for Professionals in Regulatory Affairs

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