COVID-19 procedures are in place for researchers at UCLH. All researchers should read the Read the full statement from UCLH R&D, the BRC update for researchers plus the guidance from the HRA and MHRA.
Summary
All studies, unless they fall in priority 1 studies – studies we must maintain – or
studies were there is no requirement for patient attendance at UCLH are now paused. Priority 1 studies are studies:
- of Covid-19
- where treatment is essential for serious, or life-threatening conditions
Two elements to existing studies
- whether new screening and recruitment should take place
New screening and recruitment should not take place – effective immediately, unless; - the treatment is essential for serious, or life-threatening conditions or for Studies of Covid-19 or for studies where there is no requirement for patient attendance at UCLH
- what to do with patients who are already actively involved in studies
review and/or treatment of Patients in existing studies should continue for open studies in which recruited patients would be at risk of harm if the study is paused, or studies of Covid-19. These studies should continue for patients who have already been recruited. - For all other studies, the Principal Investigator should consider very carefully whether they should be continued at this time. The portfolio will continue to be reviewed on an on-going basis.
Initiating new studies
New research studies should not be initiated until further notice – effective immediately, unless;
- The treatment is essential for serious, or life-threatening conditions
- Studies of Covid-19
- Studies where there is no requirement for patient attendance at UCLH
The UCLH Research Directorate Covid-19 Response Group, is meeting on a weekly basis, to consider the initiation of new clinical trials at UCLH on a case-by-case basis, during this period.
The NIHR has established a single, national prioritisation process for COVID-19 research to prevent duplication of effort and ensure that the resources and capacity of the health care system are not exceeded. The NIHR is maintaining a live list of COVID-19 studies that have been given urgent public health research status by the Chief Medical Officer/ Deputy Chief Medical Officer for Englan
Remote monitoring
Where sponsors and Principal Investigators determine a need to request remote access for monitors (in line with the guidance from the HRA, MHRA and UCLH), they should firstly consult the COVID-19 – UCLH Remote Monitoring Arrangements guidance document. Any questions regarding monitoring should be directed to research-incidents@ucl.ac.uk (EpicCare Link specific queries can be directed to uclh.ehrs.researchstudies@nhs.net).
UCL and UCLH sponsored studies
If your study is sponsored by UCL or UCLH please also review the guidance we issued on Friday 13 March.
