We are based within the Clinical Directorate in the Faculty of Health and Life Sciences at the University of Liverpool. With over 150 staff we work with our Chief Investigators to deliver clinical research excellence contributing expertise across all required areas: trial management, data management, statistics, information systems, monitoring and quality assurance.
Our leadership coming from the Director of the LCTC with strategy and governance provided by the Clinical Trials Oversight Committee which ensures strong clinical engagement and leadership across our portfolio areas.
The LCTC has highly skilled and experienced trial management staff with extensive expertise in managing and supporting trials from inception to closure. This includes working in close collaboration with Chief Investigators (CIs) and sponsors to facilitate the preparation of funding applications, including costings, and contributing to trial design and methodology, coordinating protocol development and providing trial management and monitoring oversight throughout a study’s duration.
Each trial will have a designated lead for trial management and an appointed trial manager who acts as the central hub for trial communication and coordination in close liaison with the CI. The trial manager, on behalf of sponsor/s, will usually coordinate the completion and submission of applications to obtain regulatory approvals and ensures that all appropriate arrangements are in place in compliance with the regulatory green light process for trial opening.
The trial manager works closely with Research and Development (R & D) departments and research teams in recruiting sites to facilitate their progress through site opening procedures, assisting with any issues during setup, recruitment and through to closure and archiving, building rapport through effective communication so that site engagement is optimised.
The main function of the LCTC Data Management team is to ensure the data integrity of all data collected throughout the life of a clinical trial. Adherence to the LCTC Data Management Standard Operating Procedures ensure that data is collected and handled appropriately in line with the Data Protection Act 2018, General Data Protection Regulation (GDPR), Good Clinical Practice (GCP) and other relevant legislation.
Data Management activities include:
- Creating a Data Management Plan to outline the way in which data will be handled, processed and stored throughout the trial.
- Designing Case Report Forms in collaboration with the Chief Investigator and Statistician in order to collect the data required for the analysis as outlined in the protocol.
- Specification of database validations to be applied to the Clinical Data Management System (CMDS).
- Specifying and performing systematic data cleaning checks on the CDMS to ensure that the data captured is accurate.
Statisticians within the LCTC play a key role in the design and planning of phase I - IV randomised controlled trials and other well-designed studies. We ensure that the most efficient and appropriate designs are used in compliance with necessary legislative frameworks. We also have input into all types of studies including feasibility studies, pilot studies, core outcome sets and other research. Statisticians will contribute to ensuring that study objectives are met, defining study outcomes, mitigating for any potential sources of bias, performing power calculations to determine the sample size and ensuring appropriate methods of randomisation, blinding, data capture and analysis are applied.
Throughout the course of the trial the statistics team will produce regular trial reports to both trial management groups and independent oversight committees and contribute to the data cleaning and monitoring activities with other members of the trial team.
The final analysis of the trial will be conducted following the pre-defined statistical analysis plan developed by the statistical team and will use methodological research relevant to the design of the trial. Statisticians contribute to the final study publication and report and are key collaborators during the course of the trial.
The LCTC Information Systems (IS) Team consists of a number of technical experts in application development, website development, database development (MACRO and REDCap), systems testing/validation and server infrastructure. The IS team provide technical expertise across the full LCTC trial portfolio, providing support for trial management systems and where appropriate, the development and enhancement of systems to facilitate effective trial management processes.
As well as providing support for systems that enable data capture, the team also provide bespoke systems development specific to trials. The IS team manage effective working relationships between external software suppliers and the University's central Computer Services Department (CSD) in order to plan, manage and build technical solutions to enable effective trial technical solutions.
LCTC Monitoring allows us to oversee the progress of a clinical trial and ensure that it is conducted, recorded and reported in accordance with the trial protocol, Standard Operating Procedures (SOPs), GCP and the applicable regulatory requirements. The determination of the extent and nature of onsite and central monitoring conducted is based on a number of considerations such as the objective, purpose, design, complexity, blinding, size, endpoints and risks of the trial.
The purpose of our monitoring is to:
- Ensure protection of the safety, rights and well-being of the subjects participating in the LCTC studies.
- Improve the quality of data captured and promoting high standards to enhance data integrity.
- Verify that a trial is being conducted in compliance with the currently approved protocol/amendments(s), GCP principles and the applicable regulatory requirements.
- Build confidence and cultivate trust while working with the sponsor and site staff.
- Think critically to resolve issues and achieve the monitoring goals which aim to verify the ongoing quality of a trial.
The LCTC’s Quality Management System (QMS) is based on regulatory requirements and the principles of GCP. The QMS is a formalised system that encompasses the responsibilities, processes and procedures of LCTC in order to achieve the quality policies and objectives. The QMS enables the organisation to identify, measure, control and enhance core research and business processes in order to maintain compliance and improve quality output.
The purpose of our QMS is to:
- Ensure that LCTC systems and processes adhere to the principles of GCP and other relevant legal, regulatory and ethical requirements which have their origin in the Declaration of Helsinki.
- Provide reassurance to regulators, collaborators, wider research community and the general public that research quality and the safe-guarding of participants are at the heart of LCTC research.
- Support continuous improvement and ensure processes are consistently applied across all LCTC managed projects thereby adding value to the reputation of LCTC as a provider of high quality clinical research.
- Respond effectively to changing requirements of funders, sponsors and regulators.