The Nottingham Clinical Trials Unit employs around 90 staff, across a range of disciplines. Although staff are organised by teams, staff frequently work with people within other teams in the Unit, representing the multidisciplinary nature of clinical trials. To find out more about the roles and responsibilities of each team, and the individual members of staff who are based in those teams, see below:
Academic staff are responsible for designing and conducting high quality, impactful research studies, with some teaching and student supervision responsibilities. Many of our academic staff also sit within other teams within NCTU.
The Data team are responsible for all aspects of data management throughout the life span of a trial. Our primary goal is to deliver good quality, robust data for statistical analysis. To achieve this, our highly experienced team work alongside our programmers to design and build data collection systems that enable us to receive, track and clean data from a variety of sources. We are an integral part of the multidisciplinary team needed to produce high quality research.
The University of Nottingham’s Health Economics group is based in the NCTU. The team primarily undertakes within-trial economic evaluations both internally within the NCTU and externally with trial units across the country. The group also undertakes a variety of research outside the trial setting, including literature reviews, decision analytic modelling, policy evaluations and the analysis of routine data sources. We have expertise in a broad range of health economic methodologies and engage with policy makers at local and national levels. We lead a portfolio of research collaborating with other teams in the school of medicine, industry, the NHS and external universities.
The Quality Assurance team work closely with all trial teams to ensure NCTU trials are safe in their conduct and produce high quality data. They are responsible for managing and maintaining a robust quality management system, which includes the review and revision of standard operating procedures (SOPs), delivery of training, auditing systems and trials, implementing and tracking corrective and preventative action plans, and overseeing breaches of the protocol and good clinical practice. The QA team contribute to the design of risk adapted processes within a trial, assisting in the development of documents such as the risk assessment and monitoring plan. The QA team are also the point of contact for advice around compliance issues and troubleshooting, ensuring deviations and non-compliance issues are logged and tracked centrally.
NCTU employs Research Fellows and Research Coordinatiors, who are responsible for conducting impactful research studies. Some of our researchers are involved in leading methodological studies, which aim to improve the way in which trials are designed and run.
NCTU statistics team work with clinical and trial management colleagues to ensure a good research question and robust trial design, minimising as much bias as possible. They calculate the sample size required for the trial, and prespecify the analyses planned. Statisticians lead on the development of the Statistical Analysis Plan (SAP), dummy tables, blind review and data analyses, and work with the trial team to contribute to the protocol and the many associated trial documents and systems including the Case Report Forms (CRFs), monitoring plan and risk assessment. Throughout the trial, they contribute to data monitoring and oversight committee reports. At the end of each trial, they analyse the data and contribute to the interpretation, reporting and dissemination of results. In addition they teach on the NCTU short course program, undertake methodological research and supervise post-graduate students. They may also act as statistical experts on external oversight committees, funding committees and as peer reviewers for journals.
The Trial Management (TM) team is comprised of Senior Trial Managers, Trial Managers, Trial Coordinators and Trial Administrators. They are the first point of contact for participating organisations delivering the trial on the ground and are responsible for the day-to-day management of our trials. The TM team are experts in project management and have detailed knowledge of ICH-GCP and ethical and regulatory guidelines. They are involved across the entire life-cycle of a trial, from design and set-up through to close-out, analysis and results dissemination. The key responsibility of the TM team is to monitor and report on the progress of the trial and to work in collaboration with the Chief Investigator, Sponsor and other experts within the CTU to ensure that the protocol is adhered to and that the trial is delivered to time and target.
The Unit Management team comprises of the Senior Unit Manager, Unit Manager, Research Coordinators, Executive Assistant and Unit Administrator. We have four core areas: Strategy and policy governance, financial management, operational management and HR management.
The team oversees and coordinates the general running of the Unit. We work with, advise, guide and support the Unit Director, Unit committees, team leads and all staff. Collaborating with colleagues to build grant application costings and ensures robust financial management of all budgets. We also coordinates the Unit’s short course and seminar programmes and supporting and develops processes and systems to add value to NCTU’s work.