(COVID-19) On March 23, 2020, new recommendations were issued by Health Canada to the attention of sponsors regarding changes that could be made to study activities (e.g. monitoring, recruitment, investigational product shipment to participants) to ensure participant safety.
Health Canada reiterates that clinical trial sites should have a system in place to identify, document and assess all protocol deviations, and to report applicable deviations to sponsors and REBs. An increase in protocol deviations is foreseeable under current circumstances.
*** This notice highlights the increased importance for research teams to work closely with sponsors and ethics committees. ***