Provincial REB Trial

Studies in Ontario, Quebec and Alberta are often approved through a provincial REB. This facilitates REB approval by having a single REB site (the REB “of record”) approve the study for all sites in the province. The REB application is uploaded through the provincial REB website and many of the materials from the original REB application can be re-used for the site application. Site-specific materials (e.g., consent forms with the local hospital logo and contact info) need to be uploaded as part of the site application. For provincial REB studies, the local hospital REB is not involved in reviewing the REB application.

Institutional/Local REB

Smaller studies, or those conducted in provinces without a central REB system need to be reviewed by the local REB. In some hospitals, the REB may be provided by another institution, such as a local academic hospital. Each REB has its own application form that needs to be completed. The study sponsors will provide many of the necessary materials (i.e., study protocol, case report forms, consent form) but you will need to add your own hospital logo and contact information to the forms before submitting them to your REB.

No Local REB

If there are no Institutional or local REB, there are REBs that can be paid to review the study and provide approval or if a local academic center has an REB, you may be able to partner with them.

The hospital will need to sign a study contract with the study sponsor that dictates the terms under which the study will be conducted. This includes a study budget and agreements around data ownership and authorship. These agreements are standard but do need to be reviewed by a legal expert, ideally someone with experience in study contracts. Ensure that you and your co-investigators have authorship rights (whether as a named author or as part of a group authorship) for any study in which you are participating. This is usually the time-limiting step of starting a study, so it is important to get this stage moving early.

Financial accounts will need to be set up according to local policies. This too can be time-consuming and challenging step to navigate.

While REB and contract negotiations are in progress, your team will have to:

Prepare your regulatory binder.
Gather training documents to provide to the sponsor for all research personnel (e.g., certificates of Good Clinical Practice (GCP), the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS2), Health Canada Division 5 , Personal Health Information Privacy Act (PHIPA), Standard Operating Procedures). Signed and dated CVs will need to be collected along with Medical License of PIs and Co-PIs as well. You may also need to gather other documentation such as laboratory ranges and accreditation documents. Site investigators and co-investigators need to read and sign off on the protocol. The delegation log needs to be signed by all personnel participating in the study. This does not include individuals who are executing their normal clinical functions such as bedside nurses or Most Responsible Physician. You will also require a locked and secure office to store study documents.

Consider making a study-specific order set to facilitate study implementation.
E.g., if your study involves a study drug, work with your local pharmacy and the sponsor to develop an order set that will be signed when a participant is enrolled in the study. Include mandatory bloodwork and other study procedures on the order set so that they don’t get missed.

Develop study procedures.
These include eligibility checklists, screening logs and study monitoring procedures to ensure the smooth running of the study. Often the study sponsors or other participating sites can provide you with their documents to help save time and effort. Investing time in these procedures at start-up can save you headaches later. Make sure you have the following policies and procedures in place for each study:

• A patient screening list
• A checklist for inclusion and exclusion criteria
• Study order set
• An enrolment form and investigator consent for enrolment
• Paper and digital copies of signed consent forms

Conduct training with the sponsor required prior to the Site Initiation Visit (SIV). E.g., database training, laboratory procedures, RC training, etc.

Site Initiation Visit (SIV).
Once the REB approval and contract negotiations are complete there will be a SIV at which the study sponsor will provide education about the study protocol and procedures. The research coordinator(s) usually attend the entire SIV, while the investigators attend for 1-2 hours to review the protocol and adverse event reporting. This is a great opportunity to clarify any questions about the protocol.

For industry-sponsored trials, site suitability is usually determined through discussion or a site eligibility questionnaire. Though this sometimes different with pharma sponsors, the site visit typically occurs when the team is ready to start enrolment.

N.B. Not all physicians in the unit need to be on the study task delegation log, but you may want them to recruit for the study when an investigator or co-investigator is not on site. You can complete a modified task delegation log providing the physician specific training on the objectives of the study, study inclusion criteria, what documents to sign, etc.

Screen potential participants, obtain consent, collect data, enter data to study database, collect source documentation, and respond promptly to queries from the sponsor.

Stay in close contact with your sponsor, ask questions and ensure you understand what data they want to collect.

Create internal data entry manuals to ensure you are capturing data from appropriate locations within your hospital system.

All studies have monitoring visits during which the study sponsor reviews study data and compares it with clinical data. This is to ensure the quality of the data being collected and to ensure that issues with study performance are addressed in a timely manner. It also ensures that sites are prepared in the event of a Health Canada review (which is a much bigger deal).

Ensure all data entered and queries are resolved, study files are archived, and ethics closed. See GCP for what needs to be on file for archiving.