Useful Resources
Sign-posting to useful resources for the management of trials and trial methodology
WORKING TOGETHER: expertise in clinical trial design and conduct
This infographic explains the collaborative relationship between the UKTMN, UKCRC CTU Network and the TMRP. The infographic explains the remit of each group and how the collaborative relationship we have adds value to the trial community.
The Clinical Trials Toolkit provides practical advice to researchers in designing and conducting publicly funded clinical trials in the UK. Through the use of an interactive route map, this site provides information on best practice and outlines the current legal and practical requirements for conducting clinical trials.
The Toolkit is primarily focused on Clinical Trials of Investigational Medicinal Products (CTIMPs) and the regulatory environment and requirements associated with these. However researchers and R&D staff working on trials in other areas will also find useful information and guidance of relevance to the wider trials environment.
Other Trial Toolkits:
The International Surgery Trials Toolkit: developed by Leeds CTRU, for use by UK researchers to guide the efficient set-up and conduct of international surgical trials.
Experimental Medicine Toolkit: aims to support investigators, research managers and ethics committees in assessing the risks involved and devising risk proportionate management and monitoring strategies in experimental medicine studies
UK Stem Cell Toolkit: A regulatory tool for those conducting human stem cell research in the UK.
The NHS Health Research Authority protects and promotes the interests of patients and the public in health and social care research. HRA Approval applies to all project-based research taking place in the NHS in England and Wales.
The Medicines and Healthcare products Regulatory Agency regulates medicines, medical devices and blood components for transfusion in the UK.
MHRA is an executive agency, sponsored by the Department of Health and Social Care.
INVOLVE was established in 1996 and is part of, and funded by, the National Institute for Health Research, to support active public involvement in NHS, public health and social care research.
The INCLUDE guidance has been designed to be used in conjunction with research, particularly in the early stages of setting-up. The guidance aims to get research teams thinking about ways of making health research more inclusive and to ensure under-served cohorts are more fairly represented in health research.
Click HERE to access INCLUDE guidance specific to COVID-19 research.
For more information and about the INCLUDE project and to access further resources, please CLICK HERE.
The UKCRC Registered CTU Network is a network of Clinical Trials Units that have been assessed against key criteria by an independent international panel of experts in clinical trials research. The Network consists of CTU members from across the UK. The CTU Network has several operational and task and finish groups which produce useful resources for the conduct of clinical trials.
NHS R&D Forum Resource Exchange
The NHS R&D Forum is a UK–wide community of practice and professional network for the health and care research management, support and leadership workforce. By working together we represent those who lead, promote, manage and support quality health research with and for NHS providers and commissioners of care; creating standards, supporting peers, and influencing UK–wide bodies as a critical friend to improve practice.
Large, single improvements are nice to have but rather rare. Marginal gains – small improvements to processes – start to add up if look across a whole system. Trial Forge aims to look across all trial processes with the intention of trying to improve them all, even if it’s just by a tiny amount, because these gains will start to add up when done across the whole trial system.
The UKCRC Registered CTU Network is a network of Clinical Trials Units that have been assessed against key criteria by an independent international panel of experts in clinical trials research. The Network consists of CTU members from across the UK. The CTU Network has several operational and task and finish groups which produce useful resources for the conduct of clinical trials.
Clinical Trials Registry
All research in the UK should be registered to a publicly accessible database and it is expected that all researchers and research sponsors meet this fundamental element of best practice. The Declaration of Helsinki states that "Every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject", and clinical trials will only be considered for publication if registered to an appropriate registry.
ISRCTN Registry: The ISRCTN (International Standard Randomised Controlled Trial Number) registry is a primary clinical trial registry recognised by WHO and ICMJE that accepts all clinical research studies (whether proposed, ongoing or completed), providing content validation and curation and the unique identification number necessary for publication. All study records in the database are freely accessible and searchable.
European Clinical Trials Register: The EU Clinical Trials Register contains information on interventional clinical trials on medicines conducted in the European Union (EU), or the European Economic Area (EEA) which started after 1 May 2004.