COVID-19

  • by Katie Neville
  • 27-Apr-2020 09:30

LCTC are following guidance released by HRA, MHRA and UKCRC registered CTU network.

LCTC are following guidance released by HRA, MHRA and UKCRC registered CTU network. All trials have been assessed regarding participant safety, trial integrity and their continuation. We are centrally co-ordinating information received from participating trusts and sites. We will continue to monitor this situation and any changes at a trial level will be communicated to sponsors and sites as necessary.

HRA https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/covid-19-guidance-sponsors-sites-and-researchers/
MHRA Blog https://mhrainspectorate.blog.gov.uk/2020/03/12/advice-for-management-of-clinical-trials-in-relation-to-coronavirus/
MHRA Website https://www.gov.uk/guidance/managing-clinical-trials-during-coronavirus-covid-19#submitting-paperwork-for-trials-which-have-been-halted
ICO https://ico.org.uk/global/data-protection-and-coronavirus-information-hub/data-protection-and-coronavirus/
FDA: "FDA Guidance on Conduct of Clinical Trials of Medicinal Products during COVID-19 Public Health Emergency" https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-public-health-emergency
EMA - COVID clinical trial general guidance (published): "Guidance on the Management of Clinical Trials during the COVID-19 Coronavirus) pandemic" https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/guidanceclinicaltrials_covid19_en.pdf
EMA COVID clinical trial methodological guidance (public consultation) - "Implications of coronavirus disease (COVID-19) on methodological aspects of ongoing clinical trials" https://www.ema.europa.eu/en/implications-coronavirus-disease-covid-19-methodological-aspects-ongoing-clinical-trials

 

COVID - 19 Other Guidance Links

NIHR Statement https://www.nihr.ac.uk/news/dhsc-issues-guidance-on-the-impact-on-covid-19-on-research-funded-or-supported-by-nihr/24469
NIHR Q&A https://www.nihr.ac.uk/documents/qanda-on-the-impact-of-covid-19-on-research-funded-or-supported-by-nihr/24467
Author: Katie Neville
Categories: Trial Related
Tags: Important
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