Sponsors & CROs
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Institutions authorized to use OCREB as a board 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 can receive OCREB approval within days. This streamlines the review process, minimizes redundancy, ensures 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. If you have questions about whether your study fits with OCREB’s mandate, please Contact Us.
Because cooperative group studies almost always open at more than one centre in Ontario eventually, 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. OCREB also will accept a new study with only one participating centre providing the sponsor is actively looking for and is confident that a second centre will agree to participate.
How OCREB works
There are two major steps to an OCREB review and to obtaining approval to conduct a study at each centre. The first step is the submission of the provincial application. Once the provincial application is approved by OCREB, the second step is the submission to OCREB of a centre-specific application by each participating centre. Part of what makes OCREB more efficient for multi-centre studies is that only one investigator is required to submit the provincial application. This investigator, or Provincial Applicant (PA) is submitting to OCREB on behalf of all participating centres in Ontario.
For more information on how OCREB works, you may download the Printable Overview of OCREB.
All applications to OCREB must be prepared and submitted using “OCREB Online (O2)”, OCREB’s online submission system. To access information about O2, including O2 support requests and user manuals, visit https://ocrebonline.ca.
How to assist a Provincial Applicant
Although an investigator/PA must submit the application, a sponsor or CRO representative may assist with any provincial (study-wide) application – i.e., initial, amendments, reportable events and continuing reviews. OCREB will create an O2 account for the sponsor/CRO representative and the PA must add the representative to the provincial application form. To request an O2 account, please contact O2 Support via email at email@example.com
OCREB Consent Form Templates
OCREB’s two consent form templates were developed by a national common consent form group now involving CCTG (formerly NCIC CTG), OCREB, British Columbia Cancer Agency (BCCA) REB, Clinical Trials Ontario (CTO), Alberta Innovates Health Solutions (AIHS), University of Saskatchewan REB (USask) and Eastern Health. The templates can be found at: OCREB Templates
These OCREB templates are mandated for all studies submitted to OCREB. The use of common consent forms facilitates 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. OCREB also collaborated with its participating Ontario centres in the development of the templates. Thus, if the approved provincial ICF follows the OCREB template, the participating centres will adopt it with minimal to no changes.
OCREB attempts to keep sponsors and CROs apprised of ICF 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 sponsor-specific consent form language. Please contact Alison van Nie, Research Ethics Officer (QA/Compliance) to discuss any proposed sponsor-specific language.
Links to Additional Information about OCREB:
- OCREB SOPs.
- For more information about OCREB, including membership lists, meeting dates, guidelines, templates and review fees, please visit https://ocrebonline.ca.
- Frequently Asked Questions.
- OCREB Annual Report 2015-16.
Regulators, study sponsors, institutions and REBs often have their own specific training requirements, which depending on the type of research, may include training in Good Clinical Practices (GCPs), in privacy legislation, in other applicable guidelines and regulations in Canada and in the U.S. and in the responsible conduct of research. Some examples and links are provided below.
- The 2nd edition of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS2) is a Canadian guideline for the ethical conduct of research involving humans and/or human biological materials. The online tutorial TCPS 2: CORE (Course on Research Ethics) is an introduction to the TCPS2. www.pre.ethics.gc.ca/eng/education/tutorial-didacticiel/
- The Canadian Network of Networks (N2) is a not-for-profit organization that is working together with the research community to promote excellence in clinical trials in Canada. N2 has partnered with the CITI program at the University of Miami to provide its members with a access to variety of research related training modules to meet the educational needs of the Canadian researchers. N2 has over 100 member organizations representing thousands of clinical research professionals. Check with your organization to find out if you already are a member. N2 Online Education Program Table of Contents
- N2 also provides member study sites with a national set of SOPs including SOPs for investigator initiated studies.N2 SOPs Table of Contents
- The Canadian Association of Research Ethics Board (CAREB/ACCER) partnered with N2 to create a national set of SOPs for REBs that reviews health sciences research. The CAREB/N2 National REB SOPs are available publicly. Adoption of the REB SOPs will facilitate standardization across REBs in Canada. N2 CAREB REB SOPs Table of Contents