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Clinical Trials

Clinical Trials Latest News:

Latest Guidance and Regulatory Updates:

updated 12th January 2021

 Latest guidance on changes to Clinical Trial processes post-Brexit

MHRA guidance on Regulation of Medical Devices in the UK from Jan 2021

MHRA guidance on changes to regulation of medical devices from 1st January 2021

 

Latest MHRA and HRA COVID-19 Updates:

updated 4th December 2020

MHRA Building resilience into clinical trial design and conduct during the pandemic

HRA COVID-19 guidance for Researchers 

MHRA COVID-19 guidance for Researchers

MHRA Managing clinical trials during Coronavirus

Process for developing new assays for COVID-19 and applying for funding

Regulatory status of equipment being used to help prevent coronavirus (COVID-19)  (this includes hand gels and PPE)

 

Re-starting clinical trials during the Coronavirus pandemic 

- updated 9th November 2020

Sponsor guidance for clinical trials resuming on-site monitoring:

  • All on-site monitoring must conform to the social distancing and quarantine rules in force at the locality at the time
  • The safety of research participants, site staff, researchers and monitorsshould be the paramount consideration in decisions about whether and how to start or re-start on-site monitoring
  • If on-site monitoring involves travel, the risk and (in)convenience of travel has to be considered
  • The monitor must be able to conform to site requirements for resuming on-site monitoring
  • Remote monitoring should continue until the minimum expectations can be met
  • The trial risk assessment should be updated to take the above points into account where relevant
  • Deviations from the monitoring plan will need documenting, and any gaps in monitoring should be addressed in the risk assessment with mitigations in place

The MHRA and HRA guidance on changes to monitoring as a result of COVID should also be taken into account:

https://www.gov.uk/guidance/managing-clinical-trials-during-coronavirus-covid-19#remote-monitoring-for-trials

https://www.hra.nhs.uk/covid-19-research/covid-19-guidance-sponsors-sites-and-researchers/#monitoring

 

Sponsor expectations for clinical trials resuming recruitment:

Please refer to the NIHR restart framework https://www.nihr.ac.uk/documents/restart-framework/24886 

The NIHR restart checklist (or adapted checklist) should be completed and for the trial to restart when ready, provided the trial risk assessment has been updated considering the risks and mitigation strategies around COVID-19 for trial staff and participants, and provided the site has given written confirmation of agreement to reopen.

Please also refer to the latest university guidance on re-starting research, at https://www.staffnet.manchester.ac.uk/rbe/ethics-integrity/ethics/

 

For more in-depth information regarding clinical trials, please see the relevant subsections.

Review timeframe

Please note the Sponsor requires 10 working days to review the following documentation. This timeframe covers our initial review only and there will be a further 10 working days for each subsequent review:

  • IRAS Documentation: REC/HRA
  • MHRA Documentation
  • Amendments
  • Greenlight Documentation 

Contact Details

Dr Mohammed Zubair - Research Governance, Ethics and Integrity Manager 
Directorate of Research and Business Engagement 
Christie Building
The University of Manchester
Manchester, M13 9PL

Email: clinicaltrials@manchester.ac.uk
Tel: 0161 275 2725 / 0161 275 2167

Lead time

The UoM require a 12 week lead time in order to consider sponsorship in principle.