Serious breaches

Article 52 of the CTR defines a serious breach as a

“breach likely to affect to a significant degree the safety and rights of a subject or the reliability and robustness of the data generated in the clinical trial.”

A serious breach should be reported by the sponsor (or delegated person) in CTIS without undue delay but not later than 7 days of becoming aware of that breach.

The GCP Inspector Working Group (ICH-IWG) from the European Medicines Agency has set up a guideline on the types of serious breaches and the reporting requirements.

In the Netherlands, CCMO will receive the serious breaches through CTIS and depending on the type of serious breach, the serious breach will be assessed by the Health and Youth Care Inspectorate, the MREC who has authorised the clinical trial or CCMO.