Sponsors & CROs
Institutions authorized to use OCREB as an REB of record
OCREB is an expert central oncology REB serving almost every hospital in the Ontario that conducts multi-centre cancer clinical trials. OCREB’s centralized model means that once a study has been approved by OCREB, participating study centres typically receive OCREB approval within days. This streamlines the review process, ensures the expertise of the reviewers, minimizes redundancies, facilitates consistency, and saves the time and cost of having the study reviewed by an REB at every participating institution.
For the purposes of its current mandate, multi-centre is defined as more than one participating Ontario centre, and clinical trial is defined as any research that prospectively assigns human participants to one or more health-related interventions to evaluate the effects on health outcomes. Interventions are restricted to drugs and other biological products, surgical procedures, radiological procedures and devices.
OCREB will accept a new study with only one confirmed participating centre, providing the sponsor is actively looking for and is confident that a second centre will agree to participate. Because cooperative group studies generally include more than one centre in Ontario, OCREB will accept the submission of all cooperative group (e.g., CCTG, NRG) multi-centre clinical trials even if a second centre has not been identified by the Provincial Applicant (PA) at the time of initial submission.
Beginning in May 2015, OCREB began accepting non-phase 1, multi-centre Children’s Oncology Group pediatric clinical trials, as the first pediatric trials reviewed by OCREB. “The Children’s Oncology Group (COG), a National Cancer Institute supported clinical trials group, is the world’s largest organization devoted exclusively to childhood and adolescent cancer research.”
Studies that meet OCREB’s mandate may be sponsored by academia, by co-operative groups or by industry/pharmaceutical companies. Approximately 50% of the submissions received by OCREB are industry-sponsored and 50% are sponsored by academia or cooperative groups, including investigator-initiated trials.
How OCREB Works
There are two major steps for obtaining OCREB approval to conduct a study at each centre. The first step is the submission of the new study via the provincial initial application (PIA). Once the PIA is approved by OCREB, the next step is the submission of a centre initial application (CIA) by each participating centre. Part of what makes OCREB effective as a central review board, as well as more efficient for multi-centre studies is the fact that only one investigator is required to submit the provincial application to OCREB. This investigator, or Provincial Applicant (PA) submits to OCREB on behalf of all participating centres in Ontario, the initial submission as well as all subsequent study-wide submissions such as amendments, safety reports, etc.
For more information on how OCREB works, download the OCREB Overview [November 28, 2017].
How to Apply
Applications to OCREB must be prepared and submitted in CTO Stream – CTO’s online submission system – using the CTO Stream clinical trial application forms. To access information about CTO Stream, including user manuals, go to www.ctontario.ca/streamlined-research-ethics-review-system/cto-stream/cto-stream-overview. For questions related to CTO Stream, contact CTO Support at 1-877-715-2700 or firstname.lastname@example.org.
NOTE. All OCREB requirements as found in its policies, procedures and consent form templates remain in effect.
Sponsor or 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. To request a CTO Stream account, contact CTO Support at 1-877-715-2700 or email@example.com.
OCREB Consent Form Templates
OCREB’s consent form templates for use in adult oncology trials were developed by a national common consent form working group, which now includes CCTG, OCREB, British Columbia Cancer Agency REB, Clinical Trials Ontario (CTO), Alberta Innovates, University of Saskatchewan REB and Eastern Health. OCREB also collaborates with its affiliated Ontario centres in the ongoing development of the templates. All provincially approved consent forms must follow the OCREB templates, and once approved, are pre-approved for adoption by the participating centres with the implementation of pre-approved, administrative changes and minimal (or no) centre-specific changes.
The OCREB consent form templates mandated for use in all current pediatric trials, have been developed in consultation with the pediatric centres, and in collaboration with COG’s template requirements.
The use of common consent forms promotes consistency in the written materials given to participants, assists with the REB review process, establishes an excellent use of ethics resources through the collaborative process, and reduces duplication of efforts. The OCREB templates are mandated for all studies submitted to OCREB.
CREB attempts to keep sponsors and CROs apprised of consent form template changes, to ensure that there is support for and compliance with the use of the templates. In the spirit of collaboration and in recognition of global responsibilities, OCREB is willing to negotiate with sponsors for supported sponsor-specific consent form language, as applicable. Please contact the OCREB Research Ethics Officer (QA/Compliance) to discuss any proposed sponsor-specific language.
CTO provides the infrastructure to allow for a single ethics review of all multi-centre clinical trials in Ontario. As one of the CTO Qualified REBs, CTO’s review fees apply to the OCREB reviews of all new studies. As of October 13, 2017, all invoices related to OCREB reviews will be managed by CTO. CTO also will manage the ongoing OCREB review fees for applicable legacy/historical studies. For information on the CTO review fees, go to CTO Review Fees.