What types of cancer research can be submitted to OCREB?
OCREB’s current mandate is restricted to multi-centre* oncology clinical trials*.
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.
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.
OCREB PROVINCIAL AND CENTRE APPLICANT ROLES
There are two major steps to an OCREB review and to obtaining approval to conduct a study at your centre. The first step is the submission to OCREB, of the provincial application. Once the provincial application is approved, the second step is the submission to OCREB of the centre-specific application(s). Part of what makes OCREB more efficient for multi-centre studies is that only one investigator is required to submit the provincial application. In essence, this investigator is submitting to OCREB on behalf of all participating centres in Ontario and thus is called the “Provincial Applicant”.
RESPONSIBILITIES OF THE OCREB PROVINCIAL APPLICANT
How do I become the Provincial Applicant?
You can be the Provincial Applicant if your centre’s Principal Investigator (PI) is the first one ready to submit a study to the REB. It’s as simple as that. If your PI is a key expert in the area under study, the sponsor also might “recommend” that your PI be the Provincial Applicant. If your PI is the NCIC Study Chair, it would be appropriate that s/he be the Provincial Applicant since s/he is in the best position to respond to questions from OCREB.
What if I don’t want to be the Provincial Applicant?
While it may be true that the Provincial Applicant has more work than other participating centres using OCREB, the overall workload should be the same as submitting to your local REB.
I am the Provincial Applicant. Now what?
Once you have decided to participate in a study and have agreed to assume the role of Provincial Applicant, simply create a new provincial application in OCREB Online (O2). The study will appear in Pre Submission, where it will be visible to the OCREB office. The OCREB office will post the study to the Project Submission Summary List where it will be visible to other centres. This will prevent another PI from starting a provincial application for the same study. Since the provincial application to OCREB contains no centre-specific information, the sponsor may be willing to help complete the application.
As the Provincial Applicant, what do I need to submit to OCREB?
The provincial applicant is responsible for submitting to OCREB the completed and signed provincial application form plus all of the supporting study documents including the protocol, sub-studies, sponsor’s proposed budget, Investigator Brochure(s) and/ or product monograph(s), provincial consent form(s), any other study participant materials such as questionnaires and diaries, the demographic page(s) of the CRF, the Health Canada NOL, etc. The sponsor also should provide the Provincial Applicant with a list of other centres that they have approached and that are considering conducting the study.
The provincial consent form will serve as the model for all participating centres and should not be on letterhead or include any centre specific information such as the PI’s name or the number of participants to be enrolled at a specific centre. Be sure to follow the OCREB template as closely as possible when submitting the provincial template. In creating the consent template, OCREB consulted with all of its member centres. As such, to be accepted at all 24 institutions, many of the sections, in particular the confidentiality, reproductive risk and compensation sections, cannot be modified. Do not include any local pre-approved language in the provincial consent form. If your centre has specific language that has been pre-approved by OCREB, it will be addressed in your centre application and approval letter.
Where do I submit?
All studies are submitted via OCREB Online (O2). The provincial application must be submitted by the deadline prior to the next OCREB meeting it will be reviewed at. Go to www.ocreb.ca or OCREB Online (O2) to view the submission deadlines and meeting dates.
Can the sponsor or CRO assist me in completing the provincial initial application?
Yes. However, the application must be submitted by the PI serving as the Provincial Applicant (PA).
A sponsor or CRO representative may assist in completing the provincial initial application providing that the sponsor/CRO agrees and the individual has been set up with an O2 account. In order to route the application to the sponsor/CRO representative, the PA must add the individual to the appropriate section of the provincial application and “Send for Sponsor Review”. Once the sponsor/CRO has completed the application, he/she must “Submit Sponsor Review” to route the application back to the Provincial Applicant to review and submit. The PA is responsible for the completeness and accuracy of the application. The PA is also responsible for communication with OCREB regarding study-related issues.
NOTE. A sponsor/CRO representative may assist with any provincial (study-wide) applications – i.e., initial applications, amendments, reportable events and continuing reviews.
The provincial materials have been submitted. What now?
Almost all of the studies submitted to OCREB are more than minimal risk. Therefore, they must be reviewed at a full Board meeting. If OCREB has any concerns or questions, the Provincial PI will be notified via a formal “review letter”. OCREB will notify the Provincial PI when the review letter has been issued. As Provincial Applicant, your PI is responsible for responding to any concerns. You and/or the PI will continue to work with OCREB (via the research ethics coordinators) to resolve any issues, including any necessary revisions to the provincial consent form. OCREB will notify you, the PI, and all potential participating centres when the provincial approval letter has been issued.
Provincial approval does not mean that a centre has approval to conduct the study. The provincial application contains no centre-specific information. For this reason, the Provincial Applicant also must submit a Centre Application to OCREB.
What if I am a Provincial Applicant and my centre is closing the study?
If you are the Provincial Applicant and the study is closing at your centre, you should contact the PI at one of the other participating centres to request that they take over as Provincial Applicant. Alternatively, you may contact OCREB to help facilitate the transfer to a PI at another centre. The Board of Record Study Agreement requires that one of the other participating centres take over the Provincial Applicant role if necessary. A Change in Provincial Applicant amendment must be submitted to OCREB and approved before the original Provincial Applicant can relinquish his/her responsibilities to the incoming Provincial Applicant.
What other responsibilities do I have as Provincial Applicant?
As the Provincial Applicant, you are responsible for submitting all study amendments, revised consents, changes to the IB, etc on behalf of all participating centres. You also are responsible for submitting all DSMB reports as well as all external serious adverse event reports that meet the OCREB reporting criteria. See Appendix 1 below for what the provincial applicant attests to by signing the provincial application form.
RESPONSIBILITIES OF THE OCREB CENTRE APPLICANT
Each centre has a study PI (Qualified Investigator) who is responsible for the conduct of the study at his/her centre. The Provincial Applicant also will be the Centre Applicant at his/her centre. The Centre PI is responsible for submitting his/her centre application to OCREB.
As a Centre Applicant, what do I do?
You must wait until the study has received provincial approval before you will be able to create and submit your centre application to OCREB. When your centre decides to conduct a study that has received provincial approval, contact O2 Support for access to the provincial study. . You must provide O2 Support with the full study title or otherwise demonstrate that the sponsor has authorized you to conduct the study before OCREB can grant you access. If the PI at your centre is listed in the Provincial Application, he/she and his/her associated study staff will automatically have access. The sponsor will provide you with all of the necessary study documents including Protocols and Investigator Brochures. Your PI should review the provincial materials (provincial application, the OCREB review letter(s) and the PI response letter(s)) and prepare your centre application.
As a Centre Applicant, what do I need to submit to OCREB?
The centre application includes:
- The centre application form – how you will conduct the study at your centre;
- The Board of Record (BOR) Study Agreement – this designates OCREB as the REB;
- Any centre-specific documents (e.g., translated materials) that were not submitted by the provincial applicant.
As a Centre Applicant, you only submit documents that are specific to your centre. The Provincial Applicant has submitted everything else on your behalf.
My centre application has been submitted. What now?
Your centre application will undergo an expedited review (by a member of OCREB). OCREB will notify you and your designated institutional contact when your centre approval letter has been issued.
What other responsibilities do I have as a Centre Applicant?
You will need to submit all local SAEs, privacy breaches, and protocol deviations to OCREB. Per the Board of Record Study Agreement, you may be asked to take on the Provincial applicant responsibilities if the Provincial applicant needs to withdraw during the conduct of the trial.
See Appendix 1 below for what the centre PI attests to by signing the centre application form.
Please contact OCREB at 416-673-6649 if you require further information or assistance on OCREB processes.
APPENDIX 1 – APPLICANT ATTESTATIONS
Provincial Applicant/Investigator Agreement:
- I attest that this application as submitted is in compliance with the Tri-Council Policy Statement; ICH Good Clinical Practice Consolidated Guidelines; Division 5, Canadian Food and Drug Regulations, and the applicable laws and regulations of Ontario;
- I attest that the information in the application is complete and accurate to the best of my knowledge;
- I attest that this application contains the current and complete protocol, including any sub-studies;
- I am aware that the OCREB review materials (i.e., provincial application form, correspondence between the PI and OCREB, approval letter) will be shared with all Ontario sites participating in this study;
- As provincial applicant, I acknowledge that I am responsible for reporting to OCREB any proposed modifications or amendments to the protocol, all external (non-local) SAEs, and updated Investigator Brochures or Product Monographs unless the sponsor formally agrees to do so on my behalf;
- I will submit an OCREB Application for Approval of Centre Participation for review/approval to conduct the study at my centre;
- I am aware that OCREB will provide the following study information to all Ontario oncology trial sites: OCREB project I.D. #, sponsor name, sponsor protocol #, REB review status, name of provincial applicant (i.e., submitting PI), and list of participating centres.
Centre Applicant Investigator Agreements:
- I attest that the information in this application is complete and accurate to the best of my knowledge;
- I assume full responsibility for the scientific and ethical conduct of the study at this institution;
- I agree to conduct this study in compliance with the Tri-Council Policy Statement; ICH Good Clinical Practices: Consolidated Guidelines; Division 5, Canadian Food and Drug Regulations; the provisions of the Ontario Personal Health Information Protection Act and its applicable Regulations; and the applicable laws and regulations of Ontario;
- I attest that I have sufficient space, time and resources to conduct this research;
- I certify that all sub-investigators, researchers and other personnel (Research Team) involved in this project at this institution are appropriately qualified and experienced, or will undergo appropriate training to fulfill their role in this project;
- I agree to promptly report to OCREB all local unexpected, serious and research related adverse events (SAEs) in respect of the study and any new information (including but not limited to protocol violations) that may adversely affect the safety of the participants or significantly affect the conduct of the study;
- I certify that this application form has been completed accurately and that OCREB approval and all external and local institutional approvals will be obtained before the trial will commence;
- I will review all provincial OCREB review materials (i.e., provincial application, correspondence between OCREB and provincial applicant, OCREB approval letter, approved model consent form);
- I certify that the Research Team will adhere to the protocol and consent form as approved by OCREB and in accordance with any conditions placed on the OCREB approval.
Privacy and Security Acknowledgement:
- On behalf of all members of my research team, I recognize the importance of maintaining the confidentiality of personal health information and the privacy of individuals with respect to that information.
- I will ensure that the personal (health) information is used only as necessary, to fulfill the specific research objectives and related research questions described in the application approved by the OCREB. This includes all conditions and restrictions imposed by the OCREB and the Institution in which the study is being conducted,governing the use, security, disclosure, return or disposal of the research participants’ personal health information.
- I agree to take any further steps required by the OCREB or the Institution to ensure that the confidentiality and security of the personal health information is maintained in accordance with the Personal Health Information Protection Act (PHIPA), its accompanying regulations, and the Tri-Council Policy Statement.