Project Design and Funding Support
EKCTU’s experienced staff can provide insight and contribute to the study design and protocol development for a trial, as well as support with applying for funding.
Trial management
Our trial management team can support you in the effective delivery of your trial, ensuring optimal recruitment and conduct of the study by:
- providing registration of the study on the appropriate publicly accessible database
- coordinating Integrated Research Application System (IRAS) submissions to obtain the appropriate approvals (for example: Research Ethics Committee (REC), Health Research Authority (HRA) and Medicines and Healthcare products Regulatory Agency)
- site selection, set-up and ongoing management
- monitoring trials to ensure conduct according to protocol and key legislation
- overseeing and escalating safety reporting for the trial
- maintaining study documentation and filing
- providing a central point of contact for queries and general facilitation of the trial
- support for the reporting requirements of the trial, i.e. preparation of Annual Progress Reports to REC and HRA
- close out of the trial and preparation for archiving
Delivery
Please see our CTU Facility page
Data management
Our experienced data management staff can assist you in advising on or providing the following for your study:
Data management plan
This plan outlines the way in which all data will be handled and processed throughout the life of the clinical trial.
Case report form and worksheet design
Case report form (CRF) and worksheets are designed to collect all relevant participant data which is then entered into the study database.
Database design, validation and testing
The database specification and data validation plan specify the structure and validation checks to be built. User acceptance testing ensures the database is fit for purpose prior to database release.
Depending on whether the study is paper-based or electronic, data can either be transcribed from CRFs/worksheets (paper-based) or entered in real-time into the database (electronic).
Database lock procedures
The activities which take place as part of database lock include: coding, serious adverse event (SAE) reconciliation (ensuring that SAEs in the database match site/investigator-held logs), and electronic investigator’s sign-off.
Data quality assessment
A series of quality control checks which verify that the data is of sufficient quality for analysis.
Data reports
Customisable reports including any data recorded in the EDC system and outstanding queries can be created regularly or ad-hoc.
Randomisation
Our CTU team can provide advice in the methodology for randomisation and unblinding, and set-up of the clinical trial randomisation system. We can provide an online randomisation using our EDC software for any study design.
Statistical support/analysis
Our qualified statistician can contribute to the conduct and analysis, supporting investigators with developing statistical analysis methods/plan, providing statistical analyses and reporting, interim analysis and contribution to final report and/or publications.
Health Economist
The CTU team can assist in designing and conducting high quality economic evaluations of healthcare interventions, modelling studies and cost analyses.
