Clinical research helps us improve health outcomes for the patients and families we serve.
We provide services and support to researchers conducting clinical trials. This applies to regulated and non-regulated studies.
Clinical trial review process
What approvals are required?
The approvals below must be obtained by the principal investigator before a clinical trial investigator can begin any research-related procedures.
- Health Canada No Objection Letter (NoL), as specified under the applicable regulations.
- Ethical Review and Certificate of Initial Ethical Approval. Ethical review is required for all research conducted at Fraser Health. Learn more about ethics and other approvals.
- Fraser Health Departmental Agreement for Providing Research-related Services Form. Researchers are responsible for:
- Submitting the appropriate documentation to each department/area as applicable for review and costing before the research budget is finalized.
- Submitting the Fraser Health Departmental Agreement for Providing Research-related Services Form to our office once approvals/signatures from applicable departments/areas have been obtained.
- Go to Fraser Health Departmental Agreement for Providing Research-related Services Form for information and guidance regarding use of the form, as well as contact information for specific departments/areas, including:
- Decision support
- Health records
- Information technology
- Laboratory medical services
- Medical imaging
- Operating rooms
- Patient care
- Clinical Trial Agreement (CTA) signed by the director of evaluation and research services.
What is the process for obtaining approval of clinical trial agreements?
Clinical trial research funded by an industry sponsor or an academic institution requires a contract between the sponsor, principal investigator and Fraser Health. We provide in-house clinical trial agreements (CTA) negotiation expertise with sponsors.
The Summary of Requirements for Sponsored Research: Appendix 1 provides a template on standard wording in the clinical trial agreement. Although designed for industry-sponsored research, the standards are also applied to the negotiation of agreements with academic sponsors.
- Submit Word document of draft CTA and site administrative information form by email to Patrick Altejos.
- Note: All draft CTAs must be submitted as an editable unlocked Word document or accompanied by a password to unlock for review and without signatures. It is the site’s responsibility to obtain an editable version from the sponsor. We will not accept draft CTAs if submitted directly by a sponsor.
- Fraser Health site is responsible for ensuring that all of their site’s requirements are included in the CTA prior to submission, e.g. payee information, sponsor contracts contact information.
- Budget may be developed by the site with the sponsor while the CTA is being negotiated.
- If an investigator is requesting our cost centre, please read the Research Accountability Guiding Document.
- Site administration form reviewed for completeness. Accurate completion of this form will ensure that the correct administrative and payee information is included in the clinical trial agreement.
- Insurance certificates are required for industry-sponsored research only; not for academic sponsored research. Insurance certificates that are not available at the time of submission must be submitted before the CTA is signed off.
Within five business days
- Draft CTA with any comments is forwarded to Patrick Altejos, who conducts all negotiations with the sponsor on behalf of Fraser Health. CTA is only negotiated if the application for ethical review has also been received by the Fraser Health Research Ethics Board.
- All correspondence with the sponsor is copied to the Fraser Health site administrative contact identified on the site administrative form and to Susan Chunick.
Within 10 business days
- We will notify the sponsor about required revisions follow up 10-15 business days. Negotiations continue until Fraser Health requirements are satisfied.
- We will advise if there are any concerns that require an executive decision prior to recommending acceptance of the CTA.
Prior to CTA finalization
- Review and finalization of the study budget is a responsibility only of the Fraser Health research site and the sponsor, and does not include review by the Contract and Business Development Specialist.
- The study budget must be agreed to by both the Fraser Health research site and the sponsor before the CTA is considered finalized.
- However, the sponsor and research site may choose to amend the budget at a later date if the budget is not finalized by the time that the legal content of the CTA is approved
- Fraser Health site reviews and approves final CTA.
- Susan Chunick, Director reviews final CTA and insurance certificate(s) before beginning signature rotation.
- Fraser Health site must ensure that the insurance certificate for the study is submitted before final review.
- Sponsor notifies if electronic signatures are acceptable.
- If original signatures are required, then sponsor sends # of required copies, as specified in the Site Administrative Form, directly to Caroline Shaker. Minimum of three originals of the CTA are required.
- Note that CTA copies are circulated for signature only when the Fraser Health Research Ethics Board has issued the certificate of ethical approval for initial ethical review or requires modifications only.
- Within three business days, Fraser Health signature is obtained.
Within one business day
- Signed CTAs are couriered to the Fraser Health site for signing. The site is responsible for forwarding onto the sponsor.
- We follow up every 10 business days until a fully executed copy of the CTA is returned to Fraser Health.
- Submit Word document of draft CTA and site administrative information form by email to Patrick Altejos.
What are the regulations?
Qualified Investigator Responsibilities
The Clinical Trial Application (CTA) for drugs, radiopharmaceuticals and natural health products or the Investigational Testing Authorization (ITA) for devices must be filed with the appropriate directorate within the Health Protection and Food Branch of Health Canada.
Clinical Drug Trials
Food and Drug Regulations provide authority to the Therapeutics Products Directorate (TPD) of the Health Products and Food Branch (HPFB) within Health Canada to regulate the conduct of research using investigational drugs for the purposes of use in human clinical trials.
Division 5 of the Regulations defines specific Clinical Trial Application (CTA) requirements and prescribes a 30-day default review period for these applications. Amendments to Division 5 were announced in June 2001 and took effect September 1, 2001.
Obligations of the Sponsor for Sponsor-initiated Trials: Sponsors must file applications to conduct clinical trials in Phases I through III of drug development. This includes applications to conduct clinical trials involving marketed products where the proposed use of the product is outside the parameters of the approved Notice of Compliance (NOC) or Drug Identification Number (DIN) application, e.g. if one or more of the following is different:
- Indication(s) and clinical use
- Target patient population(s)
- Route(s) of administration
- Dosage regimen(s)
A CTA must be filed prior to the initiation of a clinical trial in Canada. HPFB must review the application and notify the Sponsor within 30 days if the application is found to be deficient or else the Sponsor may proceed.
Obligations of the Investigator for Institutional/Investigator-initiated Clinical Trials: Investigators must also comply with the same regulatory requirements that apply to sponsor-initiated CTAs, with some modification as outlined in the guidance for clinical trial sponsors.
Obligations of the Investigator for Any Clinical Trial: For any clinical trial, there must be one qualified investigator at each clinical trial site, who is responsible for the medical decisions and care provided to clinical trial subjects. A qualified investigator must be a licensed physician or dentist. The qualified investigator must sign the qualified investigator undertaking that he/she will conduct the trial according to Good Clinical Practices as documented in the ICH Good Clinical Practice.
CTA requirements are outlined in the guidance for clinical trial sponsors document and clinical trial application form, including the requirements pertaining to local Research Ethics Board review and approval of clinical trials.
Clinical Natural Health Product Trials
Part 4 of the Natural Health Product Regulations under the Food and Drug Act governs the conduct of clinical trials using natural health products that are being developed for therapeutic purposes and has the same requirements as that of clinical drug trials with respect to sponsor and investigator obligations.
Clinical Medical Device Trials
Part 3 of the Medical Device Regulations under the Food and Drug Act – Medical Devices For Investigational Testing Involving Human Subjects governs the use of medical devices for clinical device trials.
Researchers who receive funding for clinical trials conducted by a U.S. government department and/or its agencies (e.g. Department of Health and Human Services (DHHS)/National Institute of Health/National Cancer Institute, Department of Defence, U.S. Army) OR are conducting studies regulated by the Food and Drug Administration are subject to the pertinent U.S. federal regulations. These are part of the Code of Federal Regulations (CFR) of the United States federal government.
The U.S. regulations that pertain to clinical research are:
Where do I find the Fraser Health Research Ethics Board application forms?
Where do I find the Fraser Health Research Ethics Board meeting schedule?
Where do I find the Fraser Health Research Ethics Board membership list
The Fraser Health Research Ethics Board membership reflects a variety of medical specialities as well as having legal, medical ethics and lay representation. The membership meets TCPS 2, Health Canada and United States government requirements. View the membership list here.
Where do I find the Federal Wide Assurance Number?
Under the United States Department of Health and Human Services Code of Federal Regulations 45: Part 46 A Protection of Human Subjects Section (refer to 46.103), every institution engaged in human subjects research supported or conducted by any United States Federal Department or Agency must have assurance of compliance approved by the United States Office for Human Research Protections. The Assurance formalizes the institution's commitment to protect human subjects.
The Fraser Health Research Ethics Board membership list includes the attestation information required for the Federalwide Assurance (FWA).
Office for Human Research Protections Database Federalwide Assurance and the Institutional Review Board assurance:
Registration Number: IORG: IORG0004093
Expiry Date: June 2018
Last Update: June 26, 2015 | Expires: June 26, 2018
How long will it take for my clinical trial agreement to be negotiated?
The average number of business days for the initial review of agreements and response to sponsor is nine. Most clinical trial agreements are negotiated in 30 business days.
Is there a template for a clinical trial agreement?
Is overhead collected for clinical trials?
Overhead is only collected for industry-sponsored trials, which can be regulated (i.e. drug/device trials) or non-regulated (i.e. Phase four and observational/registry studies). Overhead is not collected if the study is funded by a not-for-profit granting agency.
The overhead is 10 per cent of an industry sponsored study’s budget (as per the clinical trial agreement) based on the annual number of completed case report forms (i.e. number of participants enrolled in the study). DERS emails each site conducting an industry sponsored study an invoice at the time of annual renewal until the study is closed, at which time there will be a reconciliation to avoid over- or under-payment.
The overhead amount is based on the average administrative costs to Fraser Health of maintaining its infrastructure.
What support is available for a Fraser Health physician to conduct an investigator-initiated regulated clinical trial?
The following support is facilitated by our business and contracts development specialist:
- Assistance with preparation and submission of the Health Canada Clinical Trial Application
- Coordination of services from the Methodology Unit for the development of the research design for the research protocol
- Collaboration with the site to ensure feasibility
What educational support is available?
Fraser Health Clinical Research Coordinators’ Community of Practice (CoP)
The CoP is supported by the Department of Evaluation and Research Services. CoP sessions include annual training on N2 standard operating procedures when revised, International Conference on Harmonization Good Clinical Practices (ICHGCP) revisions (when applicable) and other continuing education topics of interest to the CoP. Certificates of attendance are provided for continuing education credits. A CoP Sharepoint site is available for access to Fraser Health coordinators and those who have a health authority email address. Requests can be made for a Fraser Health email address for external contractors and employees of service providers (e.g. physicians).
For further information, contact Alison Orth, research project leader at email@example.com.
The Collaborative Institutional Training Initiative (CITI) – Canada Education Program
The CITI-Canada Program offers comprehensive courses on a variety of research matters. Following the course, you will receive a completion certificate. This can be used to demonstrate compliance with the regulatory requirements for education in the respective topics.
For further information, contact Camille Viray, education and communications coordinator at firstname.lastname@example.org.
Association of Clinical Research Professionals (ACRP) E-Learning Library of Educational Courses
Vancouver Coastal Health Research Institute (VCHRI) and BC Clinical Research Infrastructure Network (BCCRIN) have partnered with the Association of Clinical Research Professionals (ACRP) to provide researchers and their staff access to the ACRP e-learning library of educational courses. Upon completion, you will receive a certificate of training.
Clinical Research Professionals of B.C.
Clinical Research Professionals of B.C. (CRPBC) is an informal, inclusive group of over 450 clinical research professionals who work primarily in the lower mainland of British Columbia. CRPBC provides networking and professional development opportunities for everyone working in the clinical research profession, grant funded or industry sponsored.
Clinical Trials B.C.
The B.C. Academic Health Science Network (BC AHSN) is currently working to integrate clinical research support activities of the B.C. Clinical Research Infrastructure Network (BCCRIN) into BC AHSN. The organization reflects a focus on advancing B.C. as a world leader in clinical trials, a direction endorsed by key stakeholders and the BC AHSN Board.
How can I prepare for a Health Canada inspection?
We work with investigators to ensure that all Health Canada inspection requirements have been addressed before an audit occurs.
Contact us for assistance in preparing for a Health Canada inspection.
Standard Operating Procedures for Regulated Clinical Trials
We are a member of Network of Networks (N2), a network of organizations that participate in conducting regulated clinical trials. N2 produces Health Canada compliant standard operating procedures for use by an organization’s clinical trial sites.
Contact us to access to the standard operating procedures.
Canadian Clinical Trials Asset Map
Visit our resources section for information and tools to support your clinical research.