Managing clinical trials during Coronavirus (COVID-19)
On 8th September 2021, MHRA updated the guidance on How investigators and sponsors should manage clinical trials during COVID-19.
This guidance has been developed to assist those involved in clinical trials disrupted as a result of COVID-19.
It is relevant to those involved with ongoing studies, those wishing to restart trials that have been paused or temporarily halted, and those wishing to start new studies.
This guidance will be updated as the situation changes over time.
Access to Electronic Health Records by Sponsor representatives in clinical trials
Also On 8th September 2021, MHRA updated the guidance on Access to Electronic Health Records by Sponsor representatives in clinical trials, which was jointly developed by the Health Research Authority (HRA) and MHRA, in consultation with the Information Commissioners Office (ICO), on behalf of the UK.
This guidance is for Sponsors, Contract Research Organisations (CROs), and investigator sites when considering management of personal data processed in relation to research.
The data collected and analysed during clinical trials are verified and overseen by clinical trial Sponsors via representatives such as Clinical Research Associates (CRAs) or monitors. The trial participants consent to this access of their medical records in writing, as part of the consent to take part in the clinical trial.
Refer to Electronic health records - MHRA Inspectorate for further information.