COVID-19 information for researchers

Guidance has been issued by the HRA and the Medicines and Healthcare Products Regulatory Agency (MHRA).  

Guidance for UCL and UCLH sponsored active, in-follow up and new studies.

We are here to support our investigators and would advise you or your study team liaise with your sponsor contact within the Joint Research Office if you have any concerns about how to implement this guidance. These guidance documents should be taken in relation to advice given by your host sites who will also be implementing policy surrounding research activity in their institutions. 

Please could you or your study team immediately inform your JRO Sponsor contact if you are advised of the following by a host organisation other than UCLH:

1. If your trial is halted or suspended by a host organisation
2. If you trial is unable to recruit new patients 
3. If you are deviating from the protocol in order to change visit schedules or alter methods of study drug delivery to patients (e.g. drugs being posted by pharmacy instead of pick up from the hospital). 

In some of our trials, there will be an ongoing need to ensure patient treatments continue e.g. patients enrolled in chemotherapy trials and there may be a risk of harm to patients if trial activities are suspended. If you are concerned, please contact us immediately so we can initiate the relevant discussions with our UCLH Research Directorate Covid-19 Response Group and the host organisation.

It is important that pharmacovigilance activities, including Urgent Safety Measures and Serious Adverse Event (SAE) reporting, continue where relevant, to ensure the safety of our trial participants.

The JRO will be continuing with its sponsor audit programme where possible, however will follow host site guidance. If you have any queries or concerns regarding JRO audit activity, please contact: research-incidents@ucl.ac.uk. 

For UCL sponsor monitoring activity, your Sponsor contact or CTU contact will liaise with you directly.

For new studies relating to COVID please contact the JRO on uclh.randd@nhs.net and ctimps@ucl.ac.uk marking your email as urgent with a subject header COVID 19 New Study Proposal.