Clinical Trials Toolkit news

The highly anticipated draft of the ICH E6 (R3) Guideline on good clinical practice (GCP) has been published. Here is a summary of the changes.

A video of the 'How to be a Good TSC Chair' workshop has been launched by the MRC-NIHR TMRP

Four training modules have been developed by the UKCRC Monitoring Training Group, to support the monitoring of clinical trials

HRA & MHRA Clinical Trials Consultation

New online course - Digital Tools for Efficient Clinical Trials

The combined review with the MHRA will be the only way to apply for new CTIMPs in the UK from January 2022.

“Building resilience into clinical trial design and conduct during the pandemic” has just been published on the MHRA Inspectorate blog.

NIHR Clinical Research Network - new guidance.

COVID and Me is a public engagement initiative which uses theatre to raise awareness of the importance that clinical trials play in the fight against Coronavirus.

Guidance has been issued by the DHSC on the impact of COVID-19 on NIHR research.

The HRA are holding a series of workshops to support the Pharmacy Assurance self-managed process from 1 April 2020.

The ICH E8(R1) draft Guideline on General Considerations for Clinical Trials has entered the public consultation period.

The HRA and MHRA have published plans for clinical trials in the event of a no-deal Brexit.

The HRA have launched new guidelines on how to involve patients and the public well in research.

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 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.

The HRA and MHRA are exploring ways to streamline approval and ongoing management of CTIMPs through a combined ways of working pilot.

A new survey is now open across the UK and Ireland about retention to randomised trials. The survey is aimed at people involved in running trials and anyone who has been invited to take part in one.

New guidance has just been published detailing an improved approach regarding training for Good Clinical Practice.

New UK Framework for Health and Social Care Research published, the policy sets out principles of good management and conduct of health and social care research in the UK.

The MRC has produced practical guidance on ‘Using information about people in health research’ as part of the MRC Ethics Series.

Your help is needed in prioritising areas for future research around recruitment to clinical trials.

The NIHR CRN Accelerating Digital Programme have partnered with NETSCC to develop a survey on the use of digital technologies in clinical research studies.

A workshop is being held later this year to encourage research into incontinence and will aim to provide advice and facilitate discussion for researchers who are considering, planning or seeking funding for incontinence research.

The Department of Health (DH) and the Health Research Authority (HRA) have been working together to review the standard DH contract for NIHR funded research.

The EQUATOR Network aims to increase the transparency and completeness of future published research and is currently working with the UK’s Health Research Authority to carry out a call for comments to inform their future policies on research reporting and dissemination.

A new survey has opened across Ireland and the UK, giving everyone involved in recruiting people to clinical trials the chance to submit their uncertainties about methods of recruitment and vote on the most important ideas for future research around recruitment challenges.

A single application for HRA Approval will replace separate applications for governance and legal compliance, for all study types in the NHS led from England from the end of March 2016.

The Clinical Trials Toolkit is continuing to attract a growing number of visitors. 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.

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.

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.