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.

• CTIMPs, Devices and ATIMPs

Trials that require Competent Authority approval must complete a risk assessment. CIs are requested to work with your Senior Trial Manager from Newcastle Clinical Trials Unit to complete and return to Sponsor. For trials managed by other CTUs please contact tnu-tr.sponsormanagement@nhs.net to gain a copy of the approved risk assessment.

• Randomised Control Trials (RCT)

For trials classified as RCT or ‘Trial’ on ReDA a risk assessment is available on the NJRO website. CIs should work with their Team Leads to complete and return to nuth.nuthsponsorship@nhs.net

A Sponsor representative will review and respond with an e-mail confirming green light if appropriate at this time. For trials that require this risk assessment a NuTH capacity and capability form is not required as local governance will be completed at the same time.

• All Other Studies

Sponsor is not requiring the completion of a separate risk assessment for all other trials. The capacity and capability form should still be completed as per section 1 of this document. A Sponsor representative will review both site and Sponsor restart using this document.