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The NIHR is keen to monitor the use of the Clinical Trials Toolkit, and use this information to help ensure that the resource remains useful and responsive to user needs. A recent review of the Clinical Trials Toolkit website analytics has shown that the …

The NIHR has produced a video highlighting the role that Clinical Trials Units (CTUs) play in developing an NIHR funding application, explaining both the role and benefits of working with CTUs. CTUs are specialist units which have been set up with a …

The application of the forthcoming EU Clinical Trials Regulation is linked to the full functionality of the EU portal and database under development by the European Medicines Agency (EMA). In the EMA meeting in December 2015 , the EMA Management Board …

The NIHR CRN Accelerating Digital Programme, partnering with the NIHR Evaluation Trials and Studies Coordinating Centre (NETSCC), has developed a  survey  to understand how digital technologies are currently being used to support clinical research studies …

Earlier this year, people across Ireland and the UK who are involved in the design or conduct of randomised controlled trials, or who have been invited to take part in one, were asked to respond to a survey giving their questions and comments about …

The MRC has produced practical guidance on ‘Using information about people in health research’ as part of the MRC Ethics Series.  This guidance reflects the current relevant legal framework when using information about people in health research.  It will …

The HRA has published a new UK Framework for Health and Social Care Research that replaces the Research Governance Framework. This policy framework sets out the principles of good practice in the management and conduct of health and social care research …

The HRA has published a joint statement with the MHRA on proportionate approaches to GCP training. The statement advocates that researchers should be appropriately trained by qualifications and experience for their role. Please see the HRA’s website for …

An important new survey is now open across the UK and Ireland giving everyone a chance to submit their questions and comments about retention to randomised trials.  The end result will be a ‘Top 10’ list of priorities for future research into the way …

The HRA and MHRA are exploring ways to streamline approval and ongoing management of CTIMPs through a combined ways of working pilot . The pilot  brings together the two organisations’ regulatory approvals, streamlining the process in a way that would fit …

The James Lind Alliance (JLA) would like to recruit JLA Advisers to join the team.  They are looking for independent consultants who will contract with the University of Southampton to support and facilitate JLA Priority Setting Partnerships.  A solid …

NIHR CTU Support Funding are seeking to appoint members to the Standing Advisory Committee.  This opportunity is for a  CTU Director or Professor of Trials  based in England with experience of NIHR research programmes. The role of the Standing Advisory …

The HRA  have launched new guidelines on how to involve patients and the public well in research . Four key principles are introduced for best practice in public involvement and link to a variety of sources.  … The HRA  have launched new guidelines on how …

Plans for clinical trials in the event of a no-deal Brexit have been published by both the Health Research Authority  and the Medicines and Healthcare products Regulatory Authority .  This advice includes: changes to sponsors/legal representatives, IMP …

The ICH E8(R1) draft Guideline on General Considerations for Clinical Trials has reached  Step 2b  of the ICH Process in May 2019 and has entered the public consultation period. The draft guidance can be accessed here . … The ICH E8(R1) draft Guideline on …

Pharmacy Assurance is going through a phased roll-out in England and Wales. From 1 April 2020, all NHS sponsors of Phase I-III oncology trials and Phase III non-oncology trials in England and Wales, are expected to submit their studies for review through …

Guidance has been issued by the DHSC on the impact of COVID-19 on research funded or supported by NIHR . A  Q&A on this topic is also available. Other useful guidance has also been provided by the HRA  and MHRA .  … Guidance has been issued by the DHSC on …

Prof Sue Pavitt ( NIHR CRN Nationall Specialty Lead for Oral and Dental Health Research) has been commissioned by William van't Hoff to lead a NIHR initiative aiming to highlight the importance of clinical trials particularly among underserved or seldom …

Following discussions with key stakeholders, ongoing research and hosting a series of events, the NIHR Clinical Research Network (CRN) INCLUDE steering group are delighted to have developed the following: NIHR CRN INCLUDE Guidance (General) NIHR CRN …

Updated guidance on “Building resilience into clinical trial design and conduct during the pandemic” has just been published on the  MHRA Inspectorate blog . This guidance is now available to assist trial sponsors in building resilience into new and …

From 01 January 2022, a single application process with the MHRA  will apply for new Clinical Trials of Investigational Medicinal Products (CTIMPs) in the UK. This combined review brings together Clinical Trial Authorisation and REC opinion, resulting in …

Southampton CTU has developed an online course that is freely available through FutureLearn. The course covers how digital tools can be used for the recruitment and retention of participants within clinical trials. More information can be found on the …

The HRA have been working with the Medicines and Healthcare products Regulatory Agency (MHRA) on a set of proposals which they hope will improve and strengthen the UK clinical trials legislation. They believe this will help to make the UK the best place …

  The UKCRC Registered CTU Network  Monitoring Training Group have developed four training modules for individuals, aimed to support those who are involved in clinical trial monitoring. The training modules complement the Monitoring Training  Handbook . …