Clinical Trials Ontario (CTO) is a non-profit organization established in 2012 by the Government of Ontario to strengthen, promote, and capitalize on Ontario’s competitive advantages for conducting high-quality clinical trials. Its best-known operational function — and the reason research administrators encounter it directly — is the CTO Streamlined Research Ethics Review System (CTO STREAM): a single-ethics-review model that lets one qualified research ethics board (REB) act as the ethics reviewer of record for a multi-site clinical trial across participating Ontario institutions, replacing separate site-by-site REB submissions. CTO is currently supported by the Ontario Ministry of Colleges and Universities.
The problem CTO STREAM was built to solve
Before CTO STREAM, a multi-site trial running across several Ontario hospitals or universities typically required a separate research ethics review at every participating site — each with its own submission package, its own timeline, and its own board’s interpretation of the same protocol. For a study spanning a dozen or more Ontario sites, this duplicative review was one of the most commonly cited sources of activation delay in Canadian multi-site research, since a trial could not open at any site until that site’s own REB had separately approved it, even where the underlying protocol and consent materials were identical across sites.
CTO STREAM, launched March 4, 2015, addresses this directly: rather than requiring N separate reviews for N sites, a single CTO Qualified REB conducts the ethics review of record for the whole study, and participating sites rely on that one review instead of re-reviewing the same protocol independently.
How the streamlined review model works
The mechanics rest on two linked pieces of infrastructure:
Board of record
For a given multi-site study, the study team designates one CTO Qualified REB as the board of record. That board conducts the full ethics review — protocol, consent documents, recruitment materials, and risk assessment — on behalf of every participating site, rather than each site’s local REB independently reviewing the same materials. Participating sites still retain a narrower, site-specific role: confirming local institutional requirements (for example, site-specific resources, local investigator qualifications, or institution-specific consent language) without re-adjudicating the scientific and ethical merit already reviewed by the board of record. This “one review, many sites” structure is conceptually the same problem the U.S. National Institutes of Health’s single IRB (sIRB) policy for domestic multi-site research was designed to address, though CTO STREAM is Ontario’s own province-specific implementation, governed independently of U.S. federal policy.
REB Qualification Program
Not every REB in Ontario can act as a board of record under CTO STREAM by default. A board first has to become CTO Qualified through CTO’s REB Qualification Program, which provides an external, standards-based review of the board’s governance, membership, operating procedures, and documentation against the regulations, standards, and policies that typically apply to clinical trials and health research conducted in Ontario and Canada. Qualification is what lets other institutions trust a given REB’s review enough to rely on it in place of their own — it is the accountability mechanism that makes the single-review model workable across independent institutions with no formal reporting relationship to one another.
Who participates
Per CTO’s own published figures, CTO STREAM manages a single delegated REB review for more than 1,500 multi-site studies in Ontario, spanning 110 participating institutions and 19 fully CTO Qualified REBs. These figures change as institutions join and studies close — check CTO’s Streamlined Research Ethics program page for the current count before citing a specific number in a grant submission or protocol.
What this means for a study team or research administrator
- Choosing a board of record early matters. Because the board of record’s qualification, capacity, and turnaround time set the pace for every site in the study, selecting it is a study-startup decision, not an afterthought delegated to whichever site happens to submit first.
- Site-specific review still exists. CTO STREAM removes duplicative ethics review, not local institutional sign-off — a participating site can still require its own operational or resource-readiness review even once the board of record has approved the study.
- It is Ontario-specific. A trial with sites both inside and outside Ontario cannot rely on CTO STREAM alone for its out-of-province sites; those sites remain subject to their own jurisdiction’s REB/IRB requirements, coordinated separately (or, for U.S. sites in an NIH-funded study, potentially under the NIH’s own single IRB policy).
- It complements, not replaces, other clinical-trial infrastructure. A study still needs its own clinical trial management system for site tracking, its own GCP-certified study personnel, and its own handling of matters like participant payments that a board of record’s ethics review will scrutinize but that CTO STREAM itself does not administer.
Frequently asked questions
Is Clinical Trials Ontario a government agency?
No. CTO is a non-profit organization, established in 2012 by the Government of Ontario and currently supported by the Ontario Ministry of Colleges and Universities, but it operates as an independent non-profit rather than as a government ministry or regulator.
Does CTO STREAM replace Health Canada’s regulatory review of a clinical trial?
No. CTO STREAM streamlines research ethics board review among Ontario institutions. It has no bearing on Health Canada’s Clinical Trial Application (CTA) process or on any other regulatory approval a trial needs before it can proceed.
Can any REB in Ontario act as the board of record under CTO STREAM?
No — only a REB that has completed CTO’s REB Qualification Program and holds current “CTO Qualified” status can serve as the board of record for a study using the streamlined system.
How does CTO STREAM compare to the U.S. single IRB (sIRB) requirement?
Both address the same underlying inefficiency — redundant site-by-site ethics review of an identical multi-site protocol — with a comparable “one board of record, many sites” structure. They are separate systems, however: CTO STREAM is a province-specific, Ontario-based program with its own qualification process, while the NIH’s sIRB policy is a U.S. federal funding requirement for domestic multi-site research. A study spanning both countries needs to satisfy each independently.
Sources: Clinical Trials Ontario, ctontario.ca, and CTO’s Streamlined Research Ethics program page, accessed July 2026.
