The MHRA is ready to prioritise and provide any assistance for clinical trials applications submitted for COVID-19
Prioritising COVID-19 assessments
We have procedures for rapid scientific advice, reviews and approvals and are ready to support manufactures, researchers and other regulators. We have dedicated resources to ensure this happens, as we did during the Ebola crisis when we authorised clinical trial applications within a week.
Submitting COVID-19 applications
Please submit any applications directly to the Clinical Trial Helpline by emailing email@example.com, as well as through the normal CESP route so we can begin work as soon as possible. We will then liaise closely with any applicants to ensure it’s managed as efficiently as possible.
If you want advice of any aspect of a clinical trial, call or email our Clinical Trials Unit on firstname.lastname@example.org or 020 3080 6456.
You can also contact the HRA who can advise on expedited Ethics Committee opinion.
Naming your study
As requested by the WHO, please ensure that the WHO official acronym for the coronavirus disease (COVID-19) is entered in the title field of the trial registration data set (Annex 1 XML). This will facilitate finding and extracting clinical trials related to COVID-19 from public databases.
We have separate guidance on Managing clinical trials during Coronavirus (COVID-19).