COVID-19 information for researchers and sponsors
Southampton is part of the national effort to prevent, diagnose and treat COVID-19. As we continue those efforts we are restarting other research studies.
This is in line with the National Institute of Health Research (NIHR) restart framework.
Restart and recover
We are now restarting research not related to COVID-19.
This is to ensure we continue to advance care and treatments for our patients across a range of conditions throughout the pandemic.
To keep patients and staff safe, this will involve strict infection prevention control measures, such as reducing site traffic, maintaining social distancing, facility decontamination and screening.
We aim to minimise footfall on the hospital site, ensure social distancing maintained and reduce demand on resources (facilities, staff).
The PI is responsible for ensuring participant and staff well-being and safety are protected, and that study procedures are conducted at the research sites in accordance with the protocol and GCP.
National study priority categories
NIHR has established three categories for prioritisation of study delivery:
LEVEL 1: COVID studies with Urgent Public Health (UPH) status
LEVEL 2: Non-COVID studies where patient safety may be compromised in not continuing or re-opening
LEVEL 3: All other studies (delivery to be determined through local priority setting)
The local priority setting criteria for Level 3 studies are UHS are:
- Study must be viable (sponsor, CI, PI and/or site decision)
- Clinical area that study depends on must be opening and agree
- Infection prevention policy must be in place for the care group
- Studies must be able to manage existing participants before recruiting more
Study opening is being phased. UHS R&D is working with studies in groups based on their EDGE returns. Recruitment targets will be limited initially.
Initial restart will include:
- Level 2 studies (risk of harm through delay) where resources available
- Other studies not requiring site access or clinical resources
- Studies where no additional visit duration or frequency is needed beyond standard of care
- Studies where patients not regarded as high risk if acquire COVID infection (unless specific reason)
- Studies where resource constraints and infection risk can be minimised
Study restart process
- Check if your study is viable – if not certain discuss with sponsor, CI and R&D
- Update study on EDGE – information on how to do this sent to all PIs and available here
- Daily review of returns and will either prioritise for opening, request more information, pause until conditions make possible to open
- A declaration form will be sent to PI for completion in EDGE
- A green light for restart will only be issued once the declaration is received, and there is confirmation from care group re clinical area and resource availability
Please contact email@example.com if you have any concerns or queries about individual studies or this R&D policy. We welcome suggestions as to how we can make the restart process as quick and effective as possible.