What is the Trust plan with respect to Research where the Trust is Sponsor?

Information below explains the requirements for Newcastle Sponsored trials and studies. Please note that Sponsor green light does not mean the trial/study can open at all participating sites. Investigators need to work with their Principal Investigators (PIs) across the UK to ensure all areas involved can restart. Chief Investigators (CIs) must have an awareness of other Trusts policies and opening of all sites will, in most cases, be staggered.

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What about HRA Approvals under this process?

With regard to HRA approvals, researchers should first make an application through the national prioritisation process. They will be signposted for expedited regulatory approvals so that approval review can progress in parallel to the system of assessment leading to a view from CMO/DCMO on prioritisation.

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If we have the capacity to deliver COVID-19 studies that are not a national priority, can we do so?

Yes, only when this does not impact on the system’s ability to recruit participants and/or provide the resources (including staff, samples and data) needed to support nationally prioritised research.  A group, chaired by the Clinical Director for R&D, reviews all COVID-19 pipeline studies and decisions are taken as to whether to proceed or not. The final decision rests with the Clinical Director for R&D.

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