**Regulatory talk on rapid adaptation allowed during pandemic** Hayley Dixey, MHRA [Watch the talk here][1] Throughout the Covid-19 pandemic, Medicines and Healthcare products Regulatory Agency (MHRA), a department of Health and Social Care in the UK responsible for ensuring safe medicines and functional medical devices, have been extremely busy. Hayley Dixie, a Good Clinical Practice (GCP) inspector for MHRA, examines systems used by organisations to conduct clinical trials. In this talk, Hayley discusses how GCPs are working towards building resilience and flexibility within existing regulatory frameworks, and how there will be additional guidance for clinical trials going forwards, based around a cycle of assessing, adapting, amending and reviewing (AAAR) protocols. Early stage and continuous risk assessments are key to enabling flexible protocols for setting up and managing clinical trials. In this talk, Hayley outlines these Covid specific risks, for which additional risk assessments are needed. Hayley discusses the three main steps of risk-based monitoring of clinical trials and how this has changed rapidly during Covid-19: 1) Trial-specific risk assessments allow GCPs to prioritise what data is most important to monitor and discuss how this will be done remotely, ensuring high quality data and patient safety. 2) Oversight and monitoring strategies take place in many forms, including traditional on-site monitoring, central and statistical monitoring, trial steering and data monitoring committees and other remote activities, such as telephone calls and self-assessments. These are moving towards more remote methods during Covid-19. 3) Ongoing reviews include feedback from the oversight and monitoring activities; which allows updating and amending risk assessments, further driving risk-based approaches. Feedback should include triggers for escalation, triggers to update risk assessment, oversight and monitoring, and evidence that monitoring strategy is followed. Appropriate documentation of the ongoing review is essential for driving risk-based approaches. One area that MHRA have received many queries about during Covid-19 is electronic health records (EHRs) and source data verification (SDV). Hayley discusses how monitors can be allowed access to EHRs and how SDVs can be conducted remotely. **Key points:** • Building flexibilities and resilience into existing protocols that comply with GCP allows GCP inspectors and Investigational Medicinal Product Dossiers (IMPDs) to move more easily through the AAAR cycle, without the need for time consuming applications to the MHRA. • Guidelines aim to highlight which areas are more easily adaptable, such as clinical trial monitoring and patient visits to sites. • Taking advantage of data enabled approaches to patient recruitment, management and monitoring allows remote access requirements to be already built into new clinical trial systems, whilst protecting patient safety and data integrity. [1]: https://osf.io/aqb8c/