Conduct

Once HRA NHS permission and Local Trust Management Approval has been granted, research teams can start the research project. However, there is an ongoing requirement to keep the R&D Department, the Ethics Committee and the MHRA (if the research is a clinical trial) updated with study progress.

It is a requirement of Local Trust Management Approval at Oxford University Hospitals that the date of the first participant recruited to all research studies should be reported to the R&D Department. This is a written condition of approval. Ongoing recruitment should also be reported.

Commercially sponsored research being hosted at Oxford University Hospitals has additional recruitment reporting requirements:

Research recruitment reporting

Consent is the first and critical step in involving a patient:

Consent

Safety reporting is an essential aspect of Clinical Research and applies to both Clinical Trials and Clinical Research.

Safety reporting

Serious breaches of GCP must be reported to appropriate regulatory and ethical bodies, and may be required to be reported on the Trust incident management system too.

Serious breaches

All research approved at an Ethics Committee is required to report annually, on the anniversary of that approval, the progress of that research.

• Ongoing reporting
• Research completion

Changes to a research study need to be reported to appropriate regulatory or ethical bodies, and any NHS trusts hosting the research.

Substantial and Non-substantial Amendments

Please use the links below for information about conduct.

• Consent
• Safety reporting
• Research recruitment reporting
• Good Clinical Practice (GCP) monitoring
• Amendments
• Serious breaches
• Ongoing reporting
• Research completion