OCREB is a central, expert oncology REB serving the hospitals/cancer centres (study sites) in Ontario that conduct oncology clinical trials. OCREB’s centralized model means that once a study has been approved by OCREB, participating study sites can receive OCREB approval within days. Since its first meeting in January 2004, OCREB has been working with researchers, institutions and sponsors to safeguard the rights and welfare of research participants in Ontario, while advancing ethically sound cancer research. OCREB is a program of the Ontario Institute for Cancer Research (OICR), and it is an independent body operating at arm’s length from programmatic and research structures within the OICR. OCREB is accountable to the OICR Board of Directors through the OICR and OCREB Governance Committees. CHEO has entered into an agreement authorizing OCREB to act as an external research ethics board of record for non-phase 1, multi-centre Children’s Oncology Group (COG) pediatric clinical trials being conducted under the auspices of CHEO. The Children’s Oncology Group, a National Cancer Institute supported clinical trials group, is the world’s largest organization devoted exclusively to childhood and adolescent cancer research.
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. 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, please visit their website. For questions related to CTO Stream, contact CTO Support at 1-877-715-2700 or [email protected].
Centre specific consent forms:
This process for applying centre-specific information to the provincially approved documents, without modifying the version dates, is based on a controlled honour system: i.e., centres are mandated to comply with the specified implementation of the specified changes, which are pre-identified and approved by OCREB, (as indicated in the guidance and in other centre-specific documentation (as applicable); periodic reviews of implemented study documents, including de-identified, signed ICFs are conducted to demonstrate compliance with the process.
All studies conducted under the auspices of CHEO that are using OCREB as a REB of record, are required to obtain Start Smart Institutional Approval. This process includes an administrative application ROMEO (CTO administrative application). The application includes the submission of the centre initial application, approval letter, CHEO centre consent forms and as applicable, the Health Canada No Objection letter.