Clinical Trials Toolkit news
ICH E6 R3 Guideline on GCP - Summary of Proposed Changes
01 August 2023
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.How to be a good TSC Chair workshop
31 May 2022
A video of the 'How to be a Good TSC Chair' workshop has been launched by the MRC-NIHR TMRPUKCRC Introduction to Monitoring Training - launches 05 April 2022
04 April 2022
Four training modules have been developed by the UKCRC Monitoring Training Group, to support the monitoring of clinical trialsHealth Research Authority - Consultation on clinical trials
27 January 2022
HRA & MHRA Clinical Trials ConsultationDigital Tools for Efficient Clinical Trials - Online Course
11 October 2021
New online course - Digital Tools for Efficient Clinical TrialsCombined Review with the MHRA for CTIMPs
03 August 2021
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
09 November 2020
“Building resilience into clinical trial design and conduct during the pandemic” has just been published on the MHRA Inspectorate blog.NIHR CRN INCLUDE Guidance - Making health research more inclusive
01 August 2020
NIHR Clinical Research Network - new guidance.COVID & Me Public Engagement Initiative
20 July 2020
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.DHSC guidance on the impact of COVID-19 on NIHR research
17 March 2020
Guidance has been issued by the DHSC on the impact of COVID-19 on NIHR research.HRA Pharmacy Assurance workshops
30 January 2020
The HRA are holding a series of workshops to support the Pharmacy Assurance self-managed process from 1 April 2020.Draft ICH E8 (R1) Guidance Released
11 November 2019
The ICH E8(R1) draft Guideline on General Considerations for Clinical Trials has entered the public consultation period.Plans for Clinical Trials Post Brexit
01 November 2019
The HRA and MHRA have published plans for clinical trials in the event of a no-deal Brexit.New Best Practice Principles for Public Involvement
18 July 2019
The HRA have launched new guidelines on how to involve patients and the public well in research.Opportunity for CTU Director or Professor of Trials to join the CTU Standing Advisory Committee
07 February 2019
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 is recruiting advisers to join the team
20 December 2018
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.Pilot to test a combined MHRA-REC approval process
20 November 2018
The HRA and MHRA are exploring ways to streamline approval and ongoing management of CTIMPs through a combined ways of working pilot.Questions about retaining people in clinical trials?
13 April 2018
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.Updated guidance on Good Clinical Practice (GCP) training
07 November 2017
New guidance has just been published detailing an improved approach regarding training for Good Clinical Practice.UK Policy Framework - Health and Social Care
03 November 2017
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.New Guidance: Using personal information in health research
02 October 2017
The MRC has produced practical guidance on ‘Using information about people in health research’ as part of the MRC Ethics Series.Recruitment to RCTs
17 November 2016
Your help is needed in prioritising areas for future research around recruitment to clinical trials.How digital/technology is enabling the delivery of clinical research studies - the eStudy project
04 November 2016
The NIHR CRN Accelerating Digital Programme have partnered with NETSCC to develop a survey on the use of digital technologies in clinical research studies.PSP Shared Learning Group encourages research into incontinence
09 August 2016
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.Revised Department of Health contract will benefit researchers and patients
05 August 2016
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.Invitation to take part in HRA stakeholders survey
03 August 2016
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.Questions about recruitment to clinical trials?
05 July 2016
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.HRA Approval completes implementation on 31 March 2016
05 April 2016
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.Clinical Trials Toolkit attracting new visitors
17 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 importance of Clinical Trials Units in developing an NIHR funding application
17 March 2016
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.Update on the EU Clinical Trials Regulation (EU) No 536/2014
25 January 2016
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.