Canada Considers Extending Readiness Inspections To Non-COVID-19 Trials

15 Mar 2022

Health Canada’s early inspection program helps sponsors of COVID-19 clinical trials better identify gaps in their procedures before enrolling patients. It also provides intelligence on sites that may need to undergo a full GCP inspection later.

PS1805_Test Medicine_579176380_1200.jpg — Compliance Readiness Inspections Are Conducted Earlier In The Lifecycle Of A Trial • Source: Shutterstock

A new type of inspection introduced by Health Canada to ensure regulatory compliance for clinical trials of drugs, vaccines and medical devices for COVID-19 has drawn positive feedback and could potentially be used for other types of studies.

Compliance readiness inspections (CRIs) were rolled out in October 2020 to streamline the conduct of COVID-19 trials and they have...