Last updated on 23 October 2024
The CRCT report to two oversight committees (CTOC and HTOC) on their Sponsor/Institutional oversight activities. As sponsor for clinical research, the University is responsible for quality assurance through appropriate oversight as well as for supporting research. The structure for doing this is outlined in the UoB Clinical Research Quality Manual (UoB-CQM-POL-001)(Word - 558 KB). If you have any general enquires about the Oversight Committees, please send these to crct@contacts.bham.ac.uk.
Clinical Trials Oversight Committee (CTOC)
The CTOC is responsible for overseeing the activities undertaken by UoB in its role as a (co-)sponsor, host institution or partner with other organisations for clinical research. This includes Clinical Trials of Investigational Medicinal Products (CTIMPs), and trials conducted through the UoB’s UK Clinical Research Collaboration (UKCRC)-registered Clinical Trials Units (CTUs) and other interventional trials (e.g. surgical trials, medical device trials and non-CTIMP trials), and clinical studies outside of a UoB CTU. In addition, the CTOC provide oversight of any clinical research where UoB Research Ethics Committee has stipulated that the research must be conducted to the Principles of GCP. It provides advice on decisions concerning whether particular trials are appropriate for Sponsorship, and acts as the referral point for issues arising during clinical trials. The Research Ethics, Governance & Integrity Team (REGI) and the CRCT report to the CTOC on their Sponsor oversight activities. The CTOC meet approximately every 6-8 weeks.
If you wish to speak to the Commitee's Chair (e.g., to find out about the committee or to raise a matter to CTOC), please contact Professor Colin Watts.
Human Tissue Oversight Committee (HTOC)
The HTOC is responsible for overseeing all activities surrounding the use of human tissue at UoB. The HTOC provides support for quality assurance and risk management process in relation to activities carried out under the HTA licences held by UoB. The HTOC also provides support and oversight for the MHRA MIA(IMP) licence and the Human Fertilisation and Embryology licence (under the HFE Act) held by UoB. The HTOC is also responsible for overseeing GCP compliance in laboratories undertaking the analyses of clinical trial samples at UoB. The HTOC meet approximately every 3 months.
If you wish to speak to one of the academic represents on HTOC (e.g., to find out about the committee or to raise a matter to HTOC), please contact:
Reporting pathways for Oversight Committees
The CTOC and HTOC report to the UoB Research Governance, Ethics and Integrity Committee (RGEIC); a University level committee. Both committees has members representing from the College of Life and Environmental Sciences and issues may be escalated to the PVC and Head of College when they concern activity within their college. The CTOC and HTOC also provide meeting minutes to the Internal Audit Service (a unit within the University Finance Office) and the Research & Knowledge Transfer Executive Committee in the College of Medicine and Health.