Specialist Support for Trial Management Teams
A number of roles within the CTU directly support trial management teams in their delivery of trials, each making a vital contribution to the setting-up, running and delivery of results for a clinical trial.
We have two Portfolio Leads in OCTO who are each responsible for a group of trials. They are senior trial managers with several years’ experience across a range of trials. Portfolio leads:
- are responsible for working with investigators to define the trial design and delivery model
- calculate total cost of the trial and support grant or funding applications during trial set up
- contribute to the decision making process on which clinical trials the unit should take on
Portfolio Leads are also line management for Trial Managers working on their portfolio.
Quality Assurance Lead
The QA Lead is responsible for putting in place documentations and systems that promote compliance with applicable standards (Quality Management Systems). With our QA system held in OCTRU, OCTO has a Quality Assurance Lead who's role is to:
- Support trial teams in development of risk appropriate systems for each trial
- Ensure written procedures are in place and adhered to
- Often conduct internal audits to provide assurance that systems and facilities are fit for purpose and to identify opportunities for improvement .
- Ensure sure that relevant evidence is retained to show compliance for the purposes of audit and inspection (by sponsors, regulators, funders).
Pharmacovigilance Manager & Pharmacovigilance Administrator
Our PV Manager and PV Administrator are responsible for ensuring that appropriate safety systems are in place and adhered to for all trials. Their work includes:
- Assessment of reported safety events for expectedness and relatedness
- Ensuring that events which meet pre-defined criteria are reported to regulatory bodies within legally defined timeline
This may sound simple…but oncology patients are usually receiving multiple treatments and have many co-morbidities so the information we receive is often complex , it requires careful scrutiny and assessment.
Our Data Managers are responsible for design, programming and testing of data collection systems (usually eCRFs). They work with a trial team throughout a trial on all aspects of data management. Data Managers:
- Work with trial managers to ensure that reports and data extracts are available for trial monitoring and decision making.
- Ensure that database development, testing and record keeping is compliant with applicable standards.
The statistician works with the Chief Investigator and Trial Manager to develop the trial design and statistical model, ensuring that the data collection and management plan is appropriate, write the Statistical Analysis Plan (SAP) and lead on statistical analysis of results in line with GCP and other applicable guidance.
Statistics support for OCTO trials is provided by OCTRU.
Programmers, alongside the trial team, ensure that the systems in place for capturing and managing trial data are appropriately designed, tested, validated and maintained in line with applicable legislation and good practice. Often this can mean developing bespoke solutions to enable data from multiple sources to be combined within a single trial dataset.
Detailed process and recording keeping documentation to describe and evidence process compliance is essential.
The programming team are based in OCTRU .