About us

The Clinical Research Compliance Team (CRCT) 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.

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What do we do?

The CRCT works closely with teams across Research Support Services (in particular in Research Governance and Research Ethics) 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 (CRCTU) and the Birmingham Clinical Trials Unit (BCTU) 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 are part of the West Midlands Research Training Collaborative (WMRTC).

Our main focus is on clinical research projects using human tissue and clinical research 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 and Good Manufacturing Practice (GMP). The team has a number of key responsibilities relating to clinical research:

Development and maintaining the QMS

  • Developing and maintaining the UoB Clinical Research QMS that assist researchers in the conduct of their research projects. By adhering to this QMS, staff and the University as an institution can be assured that the clinical research is conducted in compliance with the applicable regulations and international standards.

Conducting compliance reviews

  • Performing quality checks, monitoring visits and audits to assess compliance of researchers and/or Clinical Trials Units (CTUs) to any international standards, guidelines, regulations, local policies or SOPs relating to clinical research.
  • The CRCT conduct Sponsor Support Visits (SSVs), which are visit to the investigators and their teams  where UoB is the Sponsor or provides Institutional oversight for the clinical research project. The SSV involves discussions with the research team and a review of the project, including key processes and documents such as the participant consent and enrolment, the collection and processing of study data and tissue sample management, as applicable. The SSV allows best practices to be shared between research teams, as well as providing feedback in areas of work that need further attention to ensure full adherence to applicable regulations and standards.
  • The CRCT feeds back the information obtained from these compliance reviews 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.
  • The CRCT also review any Serious Breaches, audit reports and inspection reports for clinical research (co-) sponsored by the UoB to ensure appropriate action has been taken and identify any areas for further improvement on a University wide level.

Providing training and support

  • The CRCT offer project set up support to staff who are in the process of setting up a clinical research project, which is particularly useful to those setting up a project for the first time. We can provide you with tools and templates to help you develop your protocol, Participant Information Sheet and Informed Consent Form ready for submission to the relevant Research Ethics Committee. If a researcher would like further support in the development of these documents, we are happy to review the draft documentation and provide feedback to ensure the documents will satisfy the requirements of the Research Ethics Committee and/or Sponsor.
  • The CRCT also offer a number of training opportunities. See Training and Workshops. 

Meet the team

The CRCT are based located in the Medical School room WG37A and B (see UoB Campus Map: Blue zone, B1). To ensure your queries are assigned to the correct person and answered as quickly and efficiently as possible, please send all queries to the team's mailbox (crct@contacts.bham.ac.uk) or alternatively call us on +44 (0)121 414 4103. Also follow us @UoB_CRCT on X (Twitter.com).

Team Organogram  (PDF - 177 KB)

Team Members

Clinical Research Compliance Manager 

Jamie Douglas-Pugh | j.k.douglas-pugh@bham.ac.uk 

Clinical Research Compliance Manager (Laboratories)

Leanne Stones | l.stones@bham.ac.uk 

Senior Compliance Facilitator

Sarah Campbell | s.l.campbell.1@bham.ac.uk 

Senior Compliance Facilitator

Alison Leese | a.m.leese@bham.ac.uk

Senior Compliance Facilitator

Emma Taylor | e.taylor.7@bham.ac.uk

Senior Laboratory Compliance Facilitator

Carole Evans | c.evans1@bham.ac.uk 

LES College Compliance Officer

Kari Bottolfsen | k.bottolfsen@bham.ac.uk

QA trainee

Helen Wright | h.j.wright@bham.ac.uk

Senior Administrator

Raj Kaur | r.kaur.14@bham.ac.uk

All team members can be contacted via Microsoft Teams.