The Southampton Clinical Trials Unit (SCTU) is a UKCRC registered CTU with expertise in the design, conduct and analysis of multicentre interventional clinical trials. We work in partnership with investigators to deliver high quality trials that will directly influence routine clinical practice.
The SCTU receives core funding from Cancer Research UK and CTU support funding from NIHR.
Our staff have expertise in developing research questions, funding proposals, trial costing and site set up. We work with our partners to ensure smooth running, timely recruiting and high quality data acquisition and analysis.
We review all applications for support against our strategic priorities which are reviewed regularly with a view to achieving a balanced portfolio.
SCTU is committed to the responsible sharing of clinical trial data and trial samples with the wider research community. Data access is administered through the SCTU Data Release Committee. Requests for data access and sharing for SCTU trials should be completed onto the Request for Data Sharing Form and emailed to the SCTU Data Release Committee Coordinator at ctu@soton.ac.uk.
As a university we use personally-identifiable information to conduct research to improve health, care and services. As a publicly-funded organisation, we have to ensure that it is in the public interest when we use personally-identifiable information from people who have agreed to take part in research. This means that when you agree to take part in a research study, we will use your data in the ways needed to conduct and analyse the research study or trial. Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally-identifiable information possible.
Health and care research should serve the public interest, which means that we have to demonstrate that our research serves the interests of society as a whole. We do this by following the UK Policy Framework for Health and Social Care Research.
All trials managed by the university require ethically approved voluntary explicit written consent to participate. Information given to the participants, family member or carer in the trials or studies is included within the relevant participant information sheets, consent forms, and other project-specific documentation created and supplied by those running the trials. Processing your information for trials is necessary for the performance of a task carried out in the public interest (GDPR Article 6(1)(e)) and under Article 9(2)(j) necessary for archiving purposes in the public interest, scientific or historical research purposes in accordance with Article 89 (1).
Of course, all of the data submitted to us is treated confidentially. Any identifiable information will strictly not be shared with anyone outside the trial team, aside from the Health & Social Care Information Centre (HSCIC). When you kindly consented to being involved in this research, this organisation was called the NHS Information Centre, they have since changed their name to NHS Digital. This enables us to share your NHS number with this organisation and they use it to link to health and mortality datasets that they hold in order to provide us with information about your current health status.
NHS Digital receive data from the Office of National Statistics (ONS), (Note: for patients from Scotland this is collected from the National Records of Scotland), regarding any patients who have sadly died. Our trial team will then be informed, and the cause of that death. Linking with the HSCIC enables us to get information about participants, even if your treating hospital has lost contact with you.
Your participation is voluntary and we very much hope that you will continue to participate in our research and let us use your data. However, you are free to withdraw at any time and without giving a reason. A decision to withdraw at any time will not affect the standard of care you receive.
There are two options if you choose to withdraw:
Your participation is voluntary and we very much hope that you will continue to participate in our research and let us use your data. However, you are free to withdraw at any time and without giving a reason. A decision to withdraw at any time will not affect the standard of care you receive. There are two options if you choose to withdraw:
• Complete withdrawal: We will attempt no further contact. No further trial visits will be scheduled and no additional data will be collected about you from the point of your withdrawal. Note, it will not be possible to remove data that we have previously collected and processed from our analyses.
• Partial withdrawal: The information you have given us up to today will be used in our analysis but there will be no more trial visits and only information from your patient notes in hospital will be collected going forward.
For any trial which already has had substantial results and publications, we won’t be able to destroy any data we hold about you up until your withdrawal. However, your data has been de-identified so you can be assured that you will not be personally identified in any reports, presentations or publications. If you would like to obtain a copy of published results, please ask your doctor.
If you wish to withdraw either completely or partially, or have any other enquiries relating to participation, please contact Southampton Clinical Trials Unit on ctu@soton.ac.uk or 023 8120 5154.
We will hold your data for a period of time after the end of trial notification, in line with national legislation and depending on the type of trial, for a maximum of 30 years.
If you wish to raise a complaint on how we have handled your personal data, you can contact our Data Protection Officer who will investigate the matter. If you are not satisfied with our response or believe we are processing your personal data in a way that is not lawful you can complain to the Information Commissioner’s Office (ICO).
Southampton CTU have an authorised and up to date NHS digital toolkit ref EE1333879-CTU. For a copy of this toolkit please contact legalservices@soton.ac.uk quoting the toolkit reference number.
Our Data Protection Officer is a member of legal services and you can contact them at data-protection@soton.ac.uk.
POWERPOINT PRESENTATION: Partnering with a Clinical Trials Unit
PDF: Partnering with a Clinical Trials Unit
The role of Clinical Trials Units in developing an NIHR funding application: