Who Works on Trials

Data management (DM) staff are responsible for making sure the data that is collected for the trial is useful and accurate. This includes data entry clerks, who enter the data, data management assistants, who check that the data is correct, and trial coordinators and data managers who design the databases and forms that are used.

DM staff work with the statisticians and researchers at the start of the trial to decide what data should be collected in order to answer the research questions. They then figure out the best ways to collect that data, and how it can be checked for accuracy. Once that’s been decided they design forms and databases to collect the data, and write instructions on how to use them. Researchers and participants then start to send data in using those forms, and DM staff check it to make sure it all makes sense and is answering the questions we’re interested in. At the end of the trial, DM staff will do a final check of the data, find any missing pieces of data, and work with the statisticians to make sure the data is ready to be analysed.

Trial management staff are responsible for the running of the trial. They make sure that all of the correct approvals are in place, that any drugs or devices that are being used are given to the people working on the trial, and that all the trial staff understand the trial and have everything they need. They’re also responsible for getting in touch with the sites that patients are recruited from- this might be hospitals, care homes, GP surgeries or specialist centres. They will identify which sites are suitable to take part and get all of the contracts and approvals in place for them to join the trial. They stay in contact with the sites during the trial and answer any questions they may have.

Statisticians are involved from the very start of a trial. We help to decide how many people are needed on the trial (called the sample size) and how the trial will answer it’s research question by deciding what information we want to collect on the trial. At the end of the trial, we look at all the information collected on the trial and summarise it to find the answer to the research question. We also input into feeding back the results of the trial to the trial participants, funders and the research community by drafting information for newsletters, journal articles and abstracts for conferences.

To support CTRU Leeds’ extensive clinical trials work, we have a dedicated Information Systems (IS) team who provide a wide variety of services and in-house software solutions.

These include:

• Desktop support
• Registration and Randomisation systems
• Trial management systems
• Developing and maintaining trial databases in MACRO and REDCap
• Trial website development and maintenance
• Graphic design
• Developing participant contact systems
• Integrating trial databases with in-house systems

As with all aspects of handling trial data, data protections, privacy and Good Clinical Practice is at the forefront of everything IS does.

The Business Management team has a variety of roles which support processes and track data managed at the portfolio (groups of similar trials, e.g. all trials studying myeloma), division (cancer, complex interventions, or surgical interventions diagnostics and devices) or whole institute level. The wider team includes sub-teams which focus on finance, operations and portfolio coordination.

Team activity and roles include:

• Contracts and insurance
• Financial reporting and management
• Personal assistants
• Workforce planning and recruitment
• Day to day admin support
• Purchasing and travel
• Data management and reporting on research progress and outputs
• Meeting support
• Internal Communications
• Publicity
• Strategic planning – resource management and priority setting
• Other additional activities relating to particular tasks or objectives