Clinical research compliance

A row of folders and patient filesThe Clinical Research Compliance Team ensures clinical research projects and in particular clinical trials are conducted in line with any applicable regulations, international standards and University standards.

The Research Facilitators / Administrators will function as a first port of call; they will be able to sign post researchers to teams within the University with further detailed knowledge. 

General (password protected)

Clinical Trial Management (password protected)

Guidelines (password protected)

The University of Birmingham has been granted access to use the ICR guidelines for guidance and training purposes. Guidelines available are:

1.Study Start Up; 2. Clinical Trial Agreement; 3. Subject Recruitment; 4. Investigator Meetings; 5. Initiation Visits; 6. Monitoring Visits; 7. For local labs & other departments in clinical research; 8. Site Management; 9. Source Data Verification; 10. Reviewing & Collecting CRFs; 11. Site Closure Visits; 12. Pharmacy

For access please contact Leigh Challinor, Governance Support Officer l.challinor@bham.ac.uk

Trial Quality Management (password protected)

Trial Systems and Management (password protected)

IMP Management (password protected)

Data Management (password protected)

Randomisation and Binding (password protected)

Audits (password protected)

What we do

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

  • Developing University wide clinical trials policies and Standard Operating Procedures (SOPs). By adhering to these policies and SOPs any University staff involved in clinical trials and the University as an institution can be assured that the rights and wellbeing of the subjects participating in clinical trials are protected and trial data are accurate, complete and verifiable from source documents and the trial is in compliance with the approved protocol/amendment(s), Good Clinical Practice (GCP) and the applicable regulatory requirements
  • Performing quality checks and audits to assess adherence of researchers and/or CTUs to compliance to any international standards, guidelines, regulations, local policies or SOPs relating to clinical trials
  • Reviewing any Serious Breaches, audit reports and inspection reports for trials (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 trials focussing on problem resolution, training and signposting

The CRCT works closely together with the Research Governance Team to ensure new trials are set up as per University’s policies and Standard Operating Procedures and appropriate Sponsor oversight is maintained. It also works closely together with the three UKCRN fully registered Clinical Trials Units (CTUs), i.e. the Cancer Research UK Clinical Trials Unit, the Birmingham Clinical Trials Unitand the Primary Care Clinical Research and Trials Unit, to ensure best practices are shared across the University. The CRCT reports to the Clinical Trials Oversight Committee (CTOC), which is the main operational arm of the Birmingham Centre for Clinical Trials.

The CTRC has two responsibilities; firstly to advise the Research Governance Team whether or not a clinical trial using an Investigational Medicinal Product to be managed outside the CTU should receive University sponsorship and secondly for ensuring Sponsor oversight.

The CRCT also supports researchers involved in projects which use and store human tissue to ensure compliance with the Human Tissue Act (2004).

Find out more

Comprehensive information on all of the topics covered by the MDS Clinical Research Compliance Team is available to all our researchers via the Research Support Handbook  (adf login required).

There you will also find associated forms and guidelines available for download, plus contact details for specific members of staff.

For general enquiries to the MDS Clinical Research Compliance Team, please contact

E: rktoffice@contacts.bham.ac.uk T: +44 (0)121 414 9299

Or follow us on Twitter (@uob_mdsrkto)