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Research in Progress
Trial Management and Monitoring
For further guidance on trial management and monitoring , please see the relevant section of the Clinical Trials Toolkit
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R&D Audit & MHRA Inspections
In order to meet the requirements of the research governance framework, the Trust has an audit mechanism to ensure that informed consent and other procedures in the research protocol approved by the research ethics committee are being adhered to. All data and documentation associated with the study must be available for audit at the request of the appropriate auditing authority. Currently 10% of REC approved projects are randomly selected for audit inspection by the R&D Department each year. You will be informed by letter if your study is selected.
The Operational Policy on the Audit of Health Research was approved by the Board in October 2002) can be accessed below:
Operational
Policy on the Audit of Health Research 
The outcome of the audit and any recommendations will be fed back to you via letter or if necessary a meeting.
PLEASE NOTE: This policy is currently under review and will be expanded to incorporate the monitoring and auditing requirements of the Medicines for Human Use (Clinical Trials) Regulations 2004.
Where the Trust or University of Leeds is acting as Sponsor for a Clinical Trial of an Investigational Medicinal Product , there will be a greater level of monitoring required in order for the Trust/University to meet the responsibilities of the research Sponsor.
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MHRA Inspections
For further information on MHRA inspections, please see the relevant section of the Clinical Trials Toolkit by clicking here
MHRA Good Clinical Practice (GCP) inspectors assess compliance with the requirements of applicable GCP guidelines and regulations, by conducting inspections at the sites of pharmaceutical sponsor companies, contract research organisations, academic research organisations, investigational trial sites, clinical laboratories, GCP archives and other facilities involved in clinical trial research
For further information on MHRA GCP
inspections, please click
here
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