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Internal monitoring of research projects

The focus of the internal monitoring system will be clinical trials of medicinal products and trials of medical devices which are sponsored by either QMUL or the Trust.

Due to limited resources, monitoring will be limited to the local site for multi-centre studies sponsored by the Trust or QMUL.

Main aim of internal monitoring system

The Trust and QMUL monitor sponsored trials to ensure the following:-

• Essential Documents are in place in a trial file prior to patient recruitment
• Trial participants are protected by verifying that consent forms have been correctly completed
• Trial data are accurate, complete and verifiable from source documents
• The conduct of the trial is compliant with the protocol, Good Clinical Practice (GCP) and other applicable research regulations
• Adverse events and serious adverse events are recorded and reporting appropriately
• Pharmacy files contain all necessary documentation relating to the trial and that trial medication is appropriately stored and dispensed
• Any samples taken during the trial are stored, managed and transported appropriately with the correct documentation in place
• Research staff are prepared for external inspection by the MHRA

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Further information

Projects suitable for monitoring will be selected by the JRMO. The Principal Investigator will be contacted after final R&D approval is granted to arrange the first monitoring visit. Alternatively you can volunteer your project for monitoring.

For any GCP related queries, please contact Research Governance & GCP Managers