We are pleased to announce the release of a new tool to help trial teams manage protocol deviations.
Clinical trials follow a protocol that is often more than 100 pages long. The protocol describes all the trial processes including everything about how potential participants should be approached, how treatment should be delivered, and the follow-up regimen.
Whenever an action occurs (or does not occur) as described in the protocol, there is a risk for participants. These protocol deviations need to be logged and reviewed. Should there be an immediate change to the protocol? Is the deviation a serious breach which should be reported to the UK regulator (MHRA)? Are there changes to the protocol that would make the trial easier for patients or site staff or those at the Clinical Trials Unit?
To help navigate protocol deviation processes and increase trial participant safety, we have created a protocol deviation routemap to guide those running clinical trials through the protocol deviation process and provide a safer clinical trial for participants.
You can view or download a copy of the routemap here.
World Patient Safety Day was established by the World Health Organization (WHO) to promote global awareness and action on patient safety. It aims to bring together patients, families, healthcare workers, policymakers, and communities to improve safety in healthcare systems worldwide.
Patient and participant safety within Clinical Trials is at the forefront of clinical trial delivery. The UK has a very robust structure in place to ensure all clinical research is planned, delivered, and reported in line with legal requirements and guidance which ensures patient safety and data integrity (to ensure data generated within clinical trials is reliable) at all times*.
The UKCRC Registered CTU Network has a key role within the structure of clinical trial delivery in the UK as it has responsibility for managing a process which provides a registration status to UK Clinical Trial Units (CTUs)**.
This process ensures that each registered CTU has the required level of experience and expertise in place to see a research project from concept thought to reporting. In this way, registration acts as a hallmark of quality.
Potential investigators, research staff, funders of clinical trials and – importantly – participants and patients can therefore be confident of CTU expertise, quality assurance, and appropriate systems being in place throughout the trial lifecycle.
CTUs work across a wide variety of medical conditions, with some specialising in paediatric research and medicines for children – the theme for this year’s World Patient Safety Day. Units also lead the way in novel trial methodology such as the use of adaptive and platform trials
Further information on all registered CTUs can be found here.
*There are several regulations (legal requirements) in place for the conduct of clinical trials. CTUs have processes in place to ensure compliance with these, and there is oversight of activities to ensure adherence with patient safety being considered and reviewed at all times.
**CTUs are specialist non-commercial units with the expertise to design, conduct, analyse and publish clinical trials. Each unit has specialist staff across a number of roles including statistics, trial management, data management, and quality assurance. Patient safety is the priority at all times starting from the development of the initial research idea, throughout the conduct of each trial, right up until closure a. CTUs routinely ensure that patient and public involvement is embedded within every clinical trial, with Patient and Public members usually a member of Trial oversight groups.
Wednesday 17 September 2025 is World Patient Safety Day. On this day, healthcare professionals, researchers, and others work to increase global awareness and action on patient safety.
However, patient safety is a year-round commitment and is always at the forefront of the clinical trials that are managed across the UK and beyond by Clinical Trials Units (CTUs) registered by the UKCRC Registered CTU Network.
Registered CTUs devise and manage many clinical trials that collectively cover patients and participants with multiple diseases/conditions and/or injuries at all ages.
Find out more about the work of registered CTUs here.
In order to promote a greater understanding of patient safety amongst research participants, three of the CTUs in the Network – the Nottingham Clinical Trials Unit, the Centre for Clinical Trials Research, Cardiff University, and the Oxford Clinical Trials Research Unit – have, in collaboration with patients and their representative, produced a short animation explaining how safety is overseen in clinical trials.
Please visit the EXPLAIN project website https://explain.octru.ox.ac.uk to watch the animation. The page includes a link to request a copy of the animation for use in any research in any of six different language options. There are also explainer animations covering consent and randomisation.
Click here to find out more about the work of the Network.
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