The UKCRC Registered Clinical Trials Unit (CTU) Network is seeking highly experienced people with expertise in specific aspects of clinical trials to join its International Registration Review Committee.

The committee is responsible for reviewing all applications for new and ongoing membership and, as such, plays a pivotal role in ensuring that the Network continues to promote excellence and integrity in non-commercial research.

The successful candidates will have a wealth of experience, knowledge, and acumen within the field of non-commercial/academic clinical trials research, demonstrate an excellent understanding of best practice as well as current drivers for change.  They will also be able to provide specialist input in relation to either Quality Assurance or Information Systems/Information Technology and Data Management.

More detailed role descriptions, and information on how to apply, can be found below in the applicant information pack below.

• Applicant information pack

As the collective voice of non-commercial and academic clinical trials units, the Network plays an important role in engaging with Government, funders, regulators, and patients to improve and strengthen clinical research in the UK. The Network is seen internationally as an exemplar for the development of national clinical trials support. It was established in 2007, and its members are committed to setting and sharing good practice and improving standards in clinical trials.

The UKCRC CTU Network is funded by its members, and major funders have representation on the Network’s Executive Group, this includes Cancer Research UK, NIHR, Versus Arthritis, Chief Scientist Office Scotland, and Health and Social Care Research Wales.

The deadline for applications is 6pm on 31 March 2026.

The “Smarter Ways of Working” Task and Finish Group was formed to address the need to develop and share best practice across the UKCRC Network in relation to electronic serious adverse event (SAE) reporting systems.

One of the key objectives of this group was to understand current practice and share these findings with the wider UKCRC Registered CTU Network community.

The group has now a published a report which summarises the key findings of a survey they conducted in late 2022 into the different approaches taken by Registered CTUs to the use of electronic reporting systems. This work will form the basis for future discussions on opportunities for development and collaborative activities in this area.

You can download a copy of the report here.

Following a detailed review by a team of specialists from across the Network, the QA Operations Group has published updated guidance on QA oversight of laboratories.

This revised suite of materials provides guidance to CTUs assessing the suitability of laboratories processing and/or analysing samples used in clinical trials. It includes:

• Guidance for CTUs assessing the suitability of Labs processing research samples
• Guidance on training requirements for labs processing research samples
• A flowchart for oversight of laboratories by CTUs
• A Self-Assessment Questionnaire

We are very grateful for the assistance provided the MHRA in reviewing and updating this guidance, as well as the helpful feedback given by those who used the original versions.

Clinical trials units (CTUs) are involved in the running and oversight of clinical trials and other research studies. Documentation and data are produced for each study, and it is important to retain this for a period after the study ends to demonstrate good clinical practice. Wherever possible these documents and data should be stored in a format to facilitate more efficient reproduction of results.

This new guidance, published by the Data & IS Operations Group, outlines important points for CTUs to consider when creating an electronic archive for study-related data, metadata and associated documentation and may help units assess the ongoing suitability of their archiving policies and procedures.

You can download your copy of the guidance here.

What better way to mark World Environment Day 2024 than by becoming a supporter of the Concordat for the Environmental Sustainability of Research and Innovation Practice?

The UKCRC Registered CTU Network is pleased to announce that it has become an official supporter of the UK research and innovation (R&I) sector’s voluntary environmental sustainability concordat.

Ways to get involved

There are two ways to sign up to the Concordat – as a Signatory or as a Supporter. The Network has chosen to become a Supporter. This means we agree with the aims of the Concordat, but are unable to actively implement some of its priorities due to our role.

What does this mean for the Network?

In becoming a Supporter of the Concordat, we have stated our commitment to the following priority areas: Leadership, Emissions from Travel, and Collaborations & Partnership. We will report annually on our progress here on our website, as well as reporting to the UKCRC Board.

Whilst we do not have direct responsibility for issues such as procurement and estate policies, we will provide our members with tools to help support them when engaging in discussion with their host organisations on these matters.

We will also continue to continue to support the development of the Carbon Foot Printing tool for trials and champion it’s use.

Find out more

• To learn more about the aims and ambitions of the Concordat click here.

• To download the Network’s official letter of support please click here.

• You can find out more about World Environment Day, and this year’s theme of restoration, desertification, and drought resilience, here.

The UKCRC Registered Clinical Trials Unit (CTU) Network is seeking a highly experienced person with expertise in clinical trials to Chair its International Registration Review Committee. The committee is responsible for reviewing all applications for new and ongoing membership and, as such, plays a pivotal role in ensuring that the Network continues to promote excellence and integrity in non-commercial research.

The successful candidate will have a wealth of experience, knowledge, and acumen within the field of non-commercial/academic clinical trials research, demonstrate an excellent understanding of best practice as well as current drivers for change.

For a detailed role description, and information on how to apply, please visit https://ukcrc-ctu.org.uk/international-registration-review-committee-chair-role-information-for-applicants/

As the collective voice of non-commercial and academic clinical trials units, the Network plays an important role in engaging with Government, funders, regulators, and patients to improve and strengthen clinical research in the UK. The Network is seen internationally as an exemplar for the development of national clinical trials support. It was established in 2007 and its members are committed to setting and sharing good practice and improving standards in clinical trials.

The UKCRC CTU Network is funded by its members, and major funders have representation on the Network’s Executive Group, this includes: Cancer Research UK, NIHR, Versus Arthritis, Chief Scientist Office Scotland and Health and Social Care Research Wales.

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Nurses are the backbone of patient care around the world, and the importance of their role cannot be overstated.

In 1974, the International Council of Nurses (ICN) designated 12 May, the anniversary of Florence Nightingale’s birth, as International Nurses Day.  The aim was to showcase the work undertaken by nurses in the interests of patient care as well as raise awareness of some of the issues within the nursing profession itself.

Over the years, these themes have included improving the resilience of health systems, better health through nursing research, and increasing access and equity.  In 2024, they are focusing on how strategic investment in nursing can bring about both economic and societal benefits.

Thank you to nurses everywhere for everything you do!

You can find out more about the ICN and this year’s campaign here: www.icn.ch/.

2023 was an exciting time for the UKCRC Registered CTU Network with changes in the research environment and opportunities to build on learning from the pandemic and transform the design and delivery of trials.  There were also changes within the Network Secretariat.

During the year, over 750 delegates from across the Network took part in face-to-face or online events.  These included webinars on subjects as diverse as the Better Methods, Better Research funding programme and different approaches to data management.  There were also quarterly ‘monitoring clinics’ which provided an opportunity for staff with a responsibility for trial monitoring to share experiences, solutions, and best practice.

There were more than 2000 views and downloads of our guidance and training materials.  These include the training for staff undertaking clinical trial monitoring, as well as information to support units preparing to undergo MHRA inspection.  All outputs can be viewed here.

The UKCRC Registered CTU Network’s PeRSEVERE Project team has launched a dedicated website bringing together all its guidance on managing participation changes in clinical trials.

PeRSEVERE focused on participants in clinical trials stopping, reducing or changing their level of involvement.

The project aimed to address the question: how should we design and carry out clinical trials and other research, given that we know some participants will stop participating early?

PeRSEVERE was a collaborative effort, involving representatives of many different clinical trials units and different areas of expertise from across the CTU Network, as well as a patient group.

The team developed high-level principles to guide management of early end of participation in clinical trials and other research studies. Between May and August 2021, they ran a public consultation on the draft principles. The responses to the consultation were used to agree the final principles and associated explanatory guidance.

The PeRSEVERE principles, explanatory guidance, and related resources are all available at https://persevereprinciples.org.

Good Statistical Practice – Tailored GCP Training for Statisticians

This Good Statistical Practice training has been developed by the UKCRC CTU Statisticians Operations Group and was funded by the NIHR Clinical Trials Unit Efficient Trial Conduct Funding scheme.

It is a suite of 5 training modules which has been developed as stand-alone GCP training tailored to statisticians, incorporating relevant regulatory aspects in the first module. It is primarily intended as a resource for statistics teams to access for group training where discussion can pull in local practice, but has also been formatted to enable self-led training through the inclusion of additional notes.

An associated publication of the training overview and development process is under review and will be circulated across the Network once in press.

The modules are:

Module 1 – Core Good Clinical Practice training
Module 2 – Record keeping and documentation
Module 3 – Trial design, randomisation and blinding
Module 4 – Data Management
Module 5 – Statistical analysis and reporting

The project lead, Prof Deborah Stocken of the Leeds Clinical Trial Research Unit, said:

“I would like to thank my co-authors for their commitment in bringing these resources together, the statisticians from across the Network and NIHR who took part in piloting and providing feedback on the individual modules, and specifically the Network’s Statistics Operations Group who instigated the project. We are also grateful to NIHR Learn and the MHRA for their engagement and support. We hope all statisticians involved in clinical trials and medical research will find these resources helpful”.

A webinar providing the background to the project, the process that was taken in developing and piloting the resources, and the training modules themselves can be accessed via NIHR Learn.