Clinical research compliance team (CRCT)

The Clinical Research Compliance Team (CRCT) helps to ensure clinical research projects and in particular clinical trials are conducted in line with any applicable regulations, international standards and University standards.

Our main focus is on clinical research projects using human tissue and clinical trials conducted under the UK Policy Framework for Health and Social Care Research. The team has expertise in Good Clinical Practice (GCP), GCP in the laboratory, the Human Tissue Act (HTA) and Good Manufacturing Practice (GMP). We develop and maintain Quality Management Systems that assist researchers in the conduct of their research projects. In addition, we perform quality checks, monitoring visits and audits across the portfolio of clinical research projects. We provide training to our researchers and can direct researchers to external training as appropriate.

 If you have any queries or require further information, please contact us at crct@contacts.bham.ac.uk.

  • Due to the Coronavirus (COVID-19) outbreak, the CRCT will be working remotely. Please continue to direct all queries to us using the team mailbox at crct@contacts.bham.ac.uk.
  • For the University Research Ethics and Governance position on Coronavirus (COVID-19) impact on research and potential adjustments to projects that may be needed, please see the Research Governance Team

Training

The Clinical Research Compliance Team provides a variety of training courses and workshops to support staff and PhD students involved in research with participants at the University of Birmingham. 

Please note that you can still register on upcoming events. However, due to the Coronavirus (COVID-19) outbreak events may be postponed. If this happens, all attendees will be notified. You can also check each event for specific updates. 

Other upcoming training

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See also our new Training and Workshop page where you will find all the upcoming events.

UoB Principles of GCP for Clinical Research

This policy describes the set of principles of Good Clinical Practice (GCP) for the design, conduct, record and report of research that involves human participants:

Clinical Research Definitions

Statement on use of University of Birmingham as a site in regulated clinical trials

Please note that the University of Birmingham would not normally act as a ‘site’ for regulated clinical trials or surgery trials (i.e. Clinical Trials of Investigational Medicinal Products (CTIMPs) or of medical devices). 

While exceptions to this may occasionally be made, where an exception is made this will be documented in writing in a letter from the University’s Research Governance and Ethics Manager. 

This means that no patients on CTIMPs, regulated device trials or surgery trials may be recruited, receive treatment or other interventions on University premises without the express written permission of the Research Governance Manager.

What we do

The team has a number of key responsibilities relating to clinical research:

  • Developing University wide clinical research policies and Standard Operating Procedures (SOPs). By adhering to these policies and SOPs any University staff involved in clinical research and the University as an institution can be assured that the research project is conducted in compliance with the applicable regulations and international standards. Click here to access the University of Birmingham Quality Management Systems for clinical research, which contains these policies and SOPs.

  • Performing quality checks, monitoring visits and audits to assess adherence of researchers and/or Clinical Trials Units (CTUs) to compliance to any international standards, guidelines, regulations, local policies or SOPs relating to clinical research. The CRCT feeds back to relevant University oversight committees, such as the Clinical Trials Oversight Committee for clinical trials and the Human Tissue Oversight Committee for any research projects involving human tissue.

  • Reviewing any Serious Breaches, audit reports and inspection reports for clinical research (co-) sponsored by the University of Birmingham to ensure appropriate action has been taken and identify any areas for further improvement on a University wide level

  • Supporting University staff involved in clinical research focussing on problem resolution, training and signposting 

The CRCT works closely together with Research Facilitators and the Research Governance Team to ensure new research projects are set up as per University’s policies and SOPs and appropriate Sponsor oversight is maintained. It also works closely together with the two UKCRC fully registered CTUs, i.e. the Cancer Research UK Clinical Trials Unit and the Birmingham Clinical Trials Unit to ensure best practices relating to clinical trials are shared across the University. The CRCT has links with their counterparts in local trusts, again to ensure best practices are shared in the region and acts as the University representative on the Birmingham region Research and Training Collaborative

Clinical Research Compliance Team

The Clinical Research Compliance Team is responsible for developing an infrastructure for researchers involved in clinical research.  The team also takes on responsibilities relating to sponsor oversight such as audits and quality checks.

Please send all queries to crct@contacts.bham.ac.uk

Interim Deputy Director of Operations (Research & KT, MDS): Mrs Wilma van Riel
E: W.C.vanRiel@bham.ac.uk T: 0121 414 3115

Clinical Research Compliance Manager: Mr Jamil Mahmood
E: j.mahmood@bham.ac.uk T: 0121 414 6894

Clinical Research Compliance Manager (Laboratories): Dr Leanne Stones
E: l.stones@bham.ac.uk T: 0121 414 7756

Senior Compliance Facilitator:  Mrs Katie Stant
E: k.e.stant@bham.ac.uk T: 0121 414 7756

Compliance Officer (LES):  Dr Jamie Pugh
E: j.pugh@bham.ac.uk T: 0121 414 4103 

Compliance Facilitator: Miss Emma Keen
E: e.keen@bham.ac.uk T: 0121 414 9223

Compliance Facilitator: Mrs Sarah Campbell
E: s.l.campbell.1@bham.ac.uk T: 0121 414 9223

Compliance Support Officer: Mrs Leanne Beckett
E: l.beckett@bham.ac.uk T: 0121 414 4103

Serious Breach Reporting Contact Details

Serious Breach reporting contact details:

Research Governance and Ethics Team
Telephone: +44 (0)121 415 8011 (Ext. 58011)
Email: researchgovernance@contacts.bham.ac.uk