Guidance for clinical trials with decentralized elements: Health Canada inspections
Health Canada monitors clinical trials through inspections to verify that trial activities comply with legal and regulatory requirements, applicable standards and the approved protocol. Inspections may be conducted in person or remotely.
In clinical trials with decentralized elements, the main location of clinical trial site associated with the qualified investigator (QI) is the primary point of contact for an inspection.
Health Canada inspectors may request documentation from sponsors and QIs to demonstrate adequate coordination, oversight and monitoring of delegated parties, as well as the measures in place to protect participant safety.
For example, for an investigational drug that requires specific storage conditions, we may request documentation to help assess if the drug was stored appropriately when transported to remote locations, in accordance with the trial protocol. This may mean ensuring that shipping containers and configurations offer the required conditions for the maximum expected transport time, including any potential shipment delays.
We may also inspect other physical locations where study-specific activities took place. The selection of inspection locations is based on various criteria and uses a risk-based approach. Proper documentation at the main location of the clinical trial site can help us determine whether we need to inspect a decentralized location. For activities conducted remotely, all relevant information and records must be accessible for inspection at the main location of a site.
In general, routine or ad hoc procedures that don't involve protocol-specific elements or are performed in settings such as a medical imaging clinic or hospital emergency department are not subject to inspection.
We would not inspect a participant’s home except in rare cases where we have serious and time-sensitive concerns around health or safety.
Clinical trial sites and QIs are the first point of contact for inspections. Sponsors and QIs should ensure that participants are informed about a potential visit from trial monitors who may be working on behalf of sponsors or regulatory inspectors as part of the informed consent process.
Sponsors should consider inspection requirements early on when designing a clinical trial with decentralized elements, especially when trial-related activities may take place in a participant’s home. Trial-specific procedures should be conducted in appropriate settings, as some trial activities may not be suitable for a home environment. Sponsors should ensure that trial-specific procedures are conducted in appropriate settings according to their level of risk.
We inspect clinical trials to assess adherence to good clinical practices (GCP).
For information on GCP, consult:
For information on clinical trial inspections, consult: