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September 2024 - The Clinical Trials Toolkit has now been refreshed. June 2023 - Content updates to the Informed Consent and Dissemination of Results stations. … Through the use of an interactive routemap, this site provides information on best practice …

The Clinical Trials Toolkit was initially developed and launched in 2004 by the MRC and the Department of Health and Social Care to help clinical trialists and R&D managers understand the regulations and requirements for conducting trials. As the lead …

Feedback If you have any queries or feedback relating the Clinical Trials Toolkit, please contact: National Institute for Health and Care Research University of Southampton Alpha House, Enterprise Road Southampton SO16 7NS Email:  ct-toolkit@nihr.ac.uk   …

Introduction We always want to ensure that you have a positive experience when you contact us, and try to resolve your queries promptly, informatively and courteously. However, we acknowledge that sometimes problems can occur and are committed to …

… Unless otherwise indicated, the advice in the Clinical Trials Toolkit does not … and Healthcare products Regulatory Agency (MHRA), the Department of Health and Social Care (DHSC), the Medical … result of the use of the Clinical Trials Toolkit. There may be websites linked to and from this site that are operated …

What are the UK regulations? The Medicines and Healthcare Regulatory Agency (MHRA) is the competent authority that regulates CTIMPs in the UK. Before a trial can begin, it is important to confirm whether it falls within the scope of  the Medicines for …

… The National Institute for Health and Care Research … and universities, including the NIHR. The Act places a number of obligations on public authorities, and sets out … of research programmes on behalf of the NIHR, which is part of the Department of Health and Social Care. As such …

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The health research sector can sometimes use jargon. We have developed this glossary to explain these terms in more detail. You'll also find the glossary items throughout the site where they have been used. The explanation will appear by hovering above …

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Routemap The Clinical Trials Toolkit is an interactive colour-coded routemap* to help navigate through the legal and good practice arrangements surrounding setting up and managing a Clinical Trial of an Investigational Medicinal Product (CTIMP). The …

Trial Planning Phase Trial planning and design is the first station on this routemap and precedes confirming whether a trial falls within the scope of the Clinical Trial Regulations, and the Risk Assessment station. Trial Planning & Design is good …

Trial Planning Phase Confirming whether a trial falls within the scope of the Clinical Trial Regulations sits between the Trial Planning and Design station and the Risk Assessment station. This is a standard process and this station is part of the 'trial …

Trial Planning Phase The Risk Assessment station follows the Trial Planning and Design station, and confirming whether a trial falls within the scope of the Clinical Trial Regulations. Risk Assessment is good practice and is relevant to all trials. This …

Trial Planning Phase The Sponsorship station follows the Risk Assessment station and precedes a parallel process in which the Protocol is developed and R&D Consultation takes place. Sponsorship is a legal requirement which is relevant to all trials. This …

… Trial Planning Phase The Protocol Development station follows … which is relevant to all trials. This station is part of the 'trial planning phase' group of stations. … A … Trials) Regulations 2004 as: "A document that describes the objectives, design, methodology, statistical …

… Recruitment Phase The GCP & Serious Breach Reporting station follows the … which is relevant to all trials. This station is part of the 'recruitment phase' group of stations. … The … trials of investigational medicinal products (CTIMPs) to be run to the conditions and principles of Good Clinical …

Trial Planning Phase Trial Management & Monitoring follows the Protocol Development station and precedes the Trial Documentation station. Trial Management & Monitoring is a legal requirement which is relevant to all trials. This station is part of the …

Trial Planning Phase The Trial Documentation station follows the Trial Management & Monitoring station and precedes the Trial Supplies station. Trial Documentation is a legal requirement which is relevant to all trials. This station is part of the 'trial …

… 'in house', the sponsor must ensure that an IB is produced. Pharmacy Assurance Pharmacy Assurance process a single technical review for … webpages . The process involves the completion of a single pharmacy technical review per study, which can be used to …

Trial Planning Phase The Pharmacovigilance station follows the Trial Supplies station and precedes the R&D Consultation station. Pharmacovigilance is a legal requirement and is specific for trials within the Clinical Trial Regulations scope. This station …