Skip to main content

Monitoring & Audit

The Research Governance Framework (2000) and the Medicines for Human Use Regulations (2004) requires research sponsors to monitor and audit research projects and clinical trials of investigational medicinal products respectively.

To this end:

  • Organisations and researchers should ensure that research projects comply with any monitoring and audit requirements. They should make sure that researchers charged with carrying out such monitoring and audits have sufficient training, resources and support to fulfil the requirements of the role.
  • Organisations should monitor and audit research projects to ensure that they are being carried out in accordance with good practice, legal and ethical requirements, and any other guidelines, adopting a risk based and proportional approach.
  • Researchers should consider any requirements for monitoring and audit at an early stage in the design of a project.
  • Researchers should cooperate with the monitoring and audit of their research projects by applicable bodies and undertake such when required. They should cooperate with any outcomes of the monitoring and audit of their research projects. If they become aware of a need for monitoring and audit where it is not already scheduled, they should report that need to the appropriate person.

The University requires that we monitor and audit research projects to ensure that they are being carried out in accordance with good practice, legal and ethical requirements, and any other guidelines (e.g. financial) for the research. Increasingly funders are requiring consideration of monitoring and audit at application stage - winning of funding, continuation of existing funding and even prevention of financial clawback can depend on robust monitoring and audit of a project.

Funders will have specific requirements for their research projects. It is the responsibility of University staff to be aware of all the requirements of a funder for the monitoring and audit applicable to their project - including being aware of the specific terms and conditions of research projects they work on.

It is worth noting that Clinical Trials are particularly heavily regulated and it is advised staff are fully aware of guidelines for monitoring and audit for these projects. Advice and guidance can be obtained from the Clinical Trials Unit here:

Monitoring

Audit

Laboratory Notebooks

UKRIO Code of Practice for Research Includes section on Monitoring and Audit