Where a government requirement will apply because of a study-specific activity e.g. For studies taking place in the NHS, there will often be local organisational information relating to COVID-19 that will also be relevant to research participants. Wherever possible, we recommend that information about requirements or consequences of new evidence, government guidance or legislation relating to COVID-19 are provided to participants or potential participants as generic, rather than study-specific information. This should then be provided to sites as described in the tool.ĭuring the pandemic changes to legislation and government guidance are likely to be made frequently and may be introduced at short notice. Any non-substantial amendments that also do not require assessment based on the guidance below will receive an automated confirmation of receipt on submission. Guidance is given for each scenario below.Īll amendments need to be submitted in the usual way using the amendment tool and online submission. There are a number of scenarios where an existing study may need to be rapidly amended due to the wider impact of COVID-19 on NHS staffing, restrictions on movement of people or in response to Government advice. General considerations for all studies due to physical distancing.Changes instigated by individual sites due to clinical requirements.Implementing a temporary halt to all or some of the study.Changes to how treatment or an investigational medicinal product is provided to participants.Changes to how or when patients are seen to avoid exposing them to COVID-19 or to reduce the burden on clinical services.Changes to site monitoring arrangements or changes to administrative arrangements to reduce burden or physical contact with sites.Reversing arrangements put in place during COVID-19.Re-opening studies or sites that have been paused.

Arrangements for handling all amendments.Once the amendment has been submitted on-line, please email with IRAS number, study title, and amendment reference number. The Human Tissue Authority has published information regarding COVID-19 for HTA Licenced establishments.Ī fast track review process for significant substantial amendments is available, for example adding an additional arm to a national study. MHRA has published information for CTIMPs and for Medical Devices. The arrangements described are designed to ensure that changes (known as amendments) can be made quickly whilst subject to the appropriate oversight to protect the interests of participants. This guidance is for sponsors, sites and researchers who need to make changes to an existing study to manage the impact of COVID-19.

Covid 19 on existing loan arrangements