What is considered to be a breach of protocol?

The following are examples of breaches that would be classed as serious:

• A breach of Good Clinical Practice (GCP) or protocol leading to the death, hospitalisation or disability of a trial subject in the UK. Not all Serious Adverse Events (SAEs) or SUSARS (Suspected Unexpected Serious Adverse Reactions) would routinely be regarded as serious breaches, but those that are a result of GCP or protocol non-compliance might. If a SUSAR is notified as a serious breach, it will still also need to be reported and submitted to the EudraVigilance database.
• Fraud relating to clinical trial records or data that impacts on the integrity of trial subjects or scientific value of the data.
• Persistent or systematic non-compliance with GCP. For example, the uncontrolled use of protocol waivers affecting eligibility criteria, particularly if this subsequently leads to harm to trial subjects in the UK.
• Failure to control investigational medicinal product (IMP) such that subjects or the public are put at risk or the scientific value of the trial is compromised. If a serious breach occurs due to an IMP defect, then a drug defect report may also be required in addition to the serious breach notification.
• Failure to report AEs, SAEs or SUSARs in accordance with UK legislation, such that subjects are put at risk.
• For trials being conducted in the UK and elsewhere, breaches from non-UK sites should also be reported.

What should I do if I suspect a breach of protocol?

Inform the Sponsor of the study. It is the Sponsor's responsibility to report a breach of Protocol to the Medicines and Healthcare products Regulatory Agency.