CTO Submissions

The North York General Hospital Research Ethics Board (REB) was designated a "Clinical Trials Ontario (CTO) Qualified REB status" in November 2016. The Qualification status was granted by external review to ensure that the REB meets a minimum standard for REB governance, membership, operations and procedures according to the CTO REB Qualification Checklist.

As a CTO Qualified REB, North York General's REB is eligible to provide ethics review and oversight of industry-funded as well as investigator-initiated multicentre clinical trials and health-related research studies on behalf of multiple participating institutions across Ontario.

Applying to CTO stream

Abbreviations used:
BoR: Board of Record
CA: Centre Applicant
CIA: Centre Initial Application
CRO: Clinical Research Organization
Clinical Trials Ontario
IR: Institutional Representative
PA: Provincial Applicant
PI: Principal Investigator
Provincial Initial Application
REB: Research Ethics Board

Before submitting the application through the CTO stream, the NYGH researcher or delegate should confirm that the study scope meets requirements and eligibility criteria for a CTO stream submission.

A researcher planning to apply for CTO stream should:
  • Be an NYGH employee/physician with credentialed active status at NYGH,
  • Complete mandatory ethics education training, and
  • Ensure that the resources required to conduct the proposed research are available
Please contact North York General's CTO Institution Representative (IR) for details.

Who is the NYGH Institutional Representative for CTO?

Sunila Kalkar
North York General Hospital
4001 Leslie Street, Room GS-70
Toronto, Ontario  M2K 1E1
Tel: 416-756-6444 ext. 3485
Email: sunila.kalkar@nygh.on.ca

Understanding CTO stream review process

1. Process for pre-submission eligibility review

NYGH study principal investigator submits by email relevant study information (email subject line: Pre-submission eligibility inquiry for CTO) along with the Study Submission Checklist, Resources Required for Research form (If applicable), and Ethics Educational Certifications to NYGH IR, Sunila Kalkar (sunila.kalkar@nygh.on.ca) and ORI (research.innovation@nygh.on.ca).

The Director of Research and Innovation, in consultation with the NYGH IR, will determine the scope and eligibility of study for delegated REB review through CTO stream.

Research outside of delegated REB model mandate must be directed to the NYGH REB.

2. Process for application through CTO stream

If the multicentre study is deemed qualified for review through CTO stream, the NYGH researcher or delegate will initiate an application process through CTO stream. Access information about CTO stream, including user manuals, on the CTO website.

For questions related to CTO stream or to request a CTO stream account, contact CTO Support at 1-877-715-2700 or streamline@ctontario.ca. Depending on the role in the study, the eligible NYGH researcher can apply as Provincial Applicant (PA) and /or Centre Applicant (CA).

3. Applying as a Provincial Applicant

The Principal Investigator (PI) should submit a Provincial Initial Application (PIA). The PIA will need to include contact details and sign off from NYGH site PI (PA) and NYGH Institutional Representative (IR).

The study sponsor or Clinical Research Organization (CRO) representatives may create and assist with applications in CTO stream; however, the submitting investigator is responsible for the quality and content of the submissions. Research teams can immediately create CIA while working on Provincial Initial Application for any known participating study sites.

CTO will screen the Provincial Initial Application to ensure that the study meets the CTO mandate, that the appropriate institutional representative is listed in the application, and to confirm that the provincial applicant has signed the application.

If the screening requirements are fulfilled, CTO will assign the Board of Record (BoR) (any CTO qualified REB in Ontario) to advance the PIA review.

The BoR REB will review the PIA (Includes REB office screening and REB member review full board or delegated), resolving issues with PIA and approving the study.

Once the PIA is approved, each participating site can submit the Centre Initial Application (CIA) including centre specific consent forms (a modified version of the provincially approved consent form which includes site-specific information, logos, etc.)

4. If NYGH Researcher is joining the study as a Centre Applicant

The PI will submit the Centre Initial Application (CIA). The CIA will need to include contact details and sign off fromNYGH site PI, NYGH ORI Director (Dr. Michael Wood) as Department Head and NYGH Institutional Representative (IR).

The BoR REB reviews CIA, resolves issues with CIA and issues REB approval for site to participate.

Before the study activities can start at NYGH, a fully executed CTO REB of Record study agreement and other administrative approvals are required in addition to REB approval from BoR REB.

CTO stream Q&A

What is the Board of Record?
The qualified Research Ethics Board (REB) that has been delegated authority for the ethics review and ethical oversight of a particular research study with multiple participating sites by formal participation agreement.

Who is responsible for selecting the Board of Record REB?
When the new multicentre Provincial Initial Application (PIA) is submitted through CTO stream, CTO selects and assigns the appropriate CTO-qualified REB to be the Board of Record.

What are the responsibilities of the CTO Board of Record REB?
To provide ethical review and oversight of multicentre clinical research and observational research studies (industry sponsored or investigator -nitiated studies) on behalf of multiple research sites across Ontario.

If the NYGH investigator is submitting the PIA through CTO stream will the study be reviewed by NYGH REB as Board of Record?
No. Any of the CTO-qualified REB may serve as the Board of Record REB for the multicentred study. CTO selects and assigns the most appropriate CTO-qualified REB to be the Board of Record.

What is the Board of Record agreement?
The Board of Record agreement is an agreement between NYGH and the participating institution defining the roles of responsibilities of the Board of Record REB, of the institution and of the Principal investigator (PI).

Who should I contact for signatures for the NYGH Board of Record (BOR) agreement?
The sign off process is coordinated through Office of Research and Innovation. Please contact research.innovation@nygh.on.ca

What is process for BoR sign off?
The sign off process is coordinated through Office of Research and Innovation:

  • CTO will send the REB of Record Study Agreement to PI for signature.
  • The PI/delegate will send a scanned copy of the Agreement (signed by PI and witness) to ORI Director, Dr. Michael Wood (michael.wood@nygh.on.ca), whose office will obtain the necessary signature from NYGH signing authority (Dr. Donna McRitchie, Vice President, Medical and Academic Affairs)
  • The scanned copy of the agreement will be sent back to CTO (streamline@ctontario.ca) who will obtain the necessary signatures from the REB host institution
  • Fully executed agreements will be circulated via the correspondence feature in CTO stream and by email after CIA is submitted.

Who is the signing authority for NYGH Board of Record agreement?
Dr. Donna Mcritchie, Vice President, Medical and Academic Affairs, signs the Board of Record agreement on behalf of NYGH.

Will the Board of Record REB or lead site be reviewing the associated grant applications or contract proposals?
No. The BoR REB is responsible for providing ethics review and ethical oversight of research study. The administrative approvals for contract, grant management, finance etc. will be reviewed by the appropriate institutional research administration departments.
Clinical Trials Ontario logo