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Research quality assurance

Your research study can proceed once the various approvals have been received and NHS R&D Local Confirmation has been granted.

It is very likely that your trial will be regularly monitored as part of the quality control procedure, to ensure the rights, safety and wellbeing of participants are being protected, and that the trial data is accurate, complete and verifiable. The monitor will also look to see if the trial is being conducted in compliance with the approved protocol, with Good Clinical Practice (see below) and the applicable regulatory requirements.

On the other hand, auditing is a quality assurance procedure undertaken by a representative of the Sponsor which is independent of and separate from routine monitoring. The purpose is to evaluate trial conduct and compliance with the protocol, Standard Operating Procedures (see below), Good Clinical Practice and applicable regulatory requirements.

Standard Operating Procedures (SOPs) represent an additional instrument for quality control. All clinical research staff observes a comprehensive list of SOPs which demonstrate transparency in approach, and compliance with the Research Governance framework, regulatory requirements and Good Clinical Practice. We will ensure you receive timely notifications of new SOPs or changes to existing SOPs. Please contact us to obtain login details for the document quality management system and to obtain access.

Training and events

Good Clinical Practice (GCP) training is a prerequisite for all staff in the hospital who are involved in research activities. GCP training safeguards the rights, safety, wellbeing and dignity of all research subjects, and provides a standard of validity for the research. GCP training can be taken online, or through a taught course. Please contact us to arrange your training.

Investigator workshops are offered by us to encourage and signpost medical professionals who wish to take on the role of investigator. Please email us to arrange your training.

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researchoffice@rbch.nhs.uk