The Clinical Research Compliance Team 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 Research Governance Framework. 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.
For definitions of terms used in clinical research compliance, please click here.
Click here to access the University of Birmingham Quality Management Systems for clinical research.
External Workshop - How to be a good CI
Workshop – How to be a good CI- 18 September- London
Free one day workshop in London for new CIs on funded trials. To apply for this event, please email a 2-page CV showing career to date and a cover letter containing the title and funder of the trial, together with the trial abstract to email@example.com by 4pm Wed 24 June. Reference: “CI workshop 2”
Delegates must pay their own travel and expenses. See attached flyer for details.
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 Investigatory 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 three UKCRN fully registered CTUs, i.e. the Cancer Research UK Clinical Trials Unit, the Birmingham Clinical Trials Unit and the Primary Care Clinical Research and 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