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

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. 

Working with Human Biomaterial in a University of Birmingham Laboratory - 27th November, 1.00-2.00pm

This training session is applicable to staff involved in the handling, processing, receipt, storage or analysis of human biomaterial that is defined as ‘Relevant Material’ by the Human Tissue Act. The session will provide an introduction to the Human Tissue Act and an overview of the UoB Clinical Research in the Laboratory Standard Operating Procedures applicable to working with human biomaterial. Attendees will have the opportunity to participate in activities and discussion relating to the required laboratory standards and sample management processes.

Please note, due to overlap in content you do not need to attend this training session if you have already attended the Clinical Research in a University of Birmingham Laboratory training session.

To register for the Working with Human Biomaterials in a University of Birmingham training session please click here.

The range of courses on offer are always increasing so please visit regularly to find out about new and upcoming courses.  Please contact CRCT for details.

UoB Principles of GCP for Clinical Research

The set of principles of Good Clinical Practice (GCP) outlined in the document below need to be adhered to for any clinical research sponsored by the University of Birmingham (UoB):

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

Head of Clinical Research Compliance: Mrs Wilma Van Riel
E: w.c.vanriel@bham.ac.uk T: 0121 414 9050

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

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

Senior Compliance Facilitator (Laboratories) : Dr Leanne Stones
E: l.stones@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

 

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