The QMN Weekly Bulletin
Pharmaceuticals / Regulatory Affairs

EMA Issues Guideline for Reporting Clinical Trial Protocol Breaches

June 2, 2017
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The European Medicines Agency has issued a new draft guideline on reporting breaches of clinical trial protocols.

The guideline calls for sponsors or anyone in a contractual research agreement to notify European Union officials within seven calendar days of a potential protocol breach.

If a breach occurs outside the EU but could impact the integrity of a trial already authorized or being conducted within the EU, sponsors should notify the relevant EU member state.

A breach is considered serious if it is likely to affect a trial subject’s safety and rights, or the reliability of the data generated in the trial. Examples of serious breaches include dosing errors, emergency unblinding, incorrect sample processing and other failures in protocol compliance.

In assessing breaches, investigators and sponsors must consider: whether subjects whose safety may have been compromised have been informed; if the root cause has been identified as human error, lack of training or failure to follow procedures; whether the issue is systematic and could affect other trials; and whether the affected data is salvageable or it must be removed entirely from the trial.

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