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Oxford University Hospitals NHS Foundation Trust
Research and Development

Coronavirus / COVID-19

If you have a new continuous cough and/or high temperaturedo not come to our hospitals.

Follow the national advice and stay at home for seven days. For most people, coronavirus (COVID-19) will be a mild infection, but for some of our patients it is a higher risk. Please help us to help you.

Important information about non-urgent inpatient operations and outpatient appointments.

From Monday 23 March we will not allow any visitors to our hospitals – with a few exceptions.

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Serious breaches

Serious breaches of GCP or the Protocol

The MHRA have a definition of a serious breach of GCP: a 'serious breach' is a breach that is likely to affect to a significant degree:

  • the safety or physical or mental integrity of the participants; or
  • the scientific value of the trial.

In the event that a serious breach is suspected, the OUH R&D Department must be contacted so that an investigation of the concern can be undertaken as a matter of urgency.

The Clinical Trials regulations state that the Sponsor is required to report serious breaches to the REC, and MHRA (where applicable) within seven days of becoming aware of the breach.

OUH R&D can provide information on what should, or should not, be classified as a serious breach and on the practical arrangements for notifications.

The Regulations define 'serious breaches' as any serious breach of: