Find out about the clinical research approval process, as well as requirements and resources available for Fraser Health researcher and research staff.
Clinical research regulations
See research policies and legislation for Health Canada, United States, and international regulations for regulated studies.
How can I prepare for a Health Canada inspection?
With proper notice as soon as the Health Canada inspection letter is received by the site, the Department of Evaluation and Research Services will work with Fraser Health investigators to ensure that their site is prepared for the inspection by Health Canada.
Please contact the Clinical Trials and Business Development Manager for assistance in preparing for a Health Canada inspection.
How do I get a DUNS number and/or a SAM number?
A Data Universal Number System (DUNS) number is a unique nine-character number used to identify an organization. You will need the DUNS number to register with the System for Award Management (SAM) to receive grant payments from the U.S. federal government. After registering with the SAM, you will be able to obtain a SAM number or a Commercial and Government Entity Code (CAGE Code). For entities located outside of the U.S. and its territories, a NATO Commercial and Government Entity Code (NCAGE Code) will be issued instead. A NCAGE is a five-character alphanumeric identifier.
Please contact the Department of Evaluation and Research Services for Fraser Health’s DUNS number and/or SAM number.
Fraser Health approval process
The following approvals must be obtained by the Fraser Health principal investigator prior to conducting any research-related procedures:
- Health Canada No Objection Letter (NoL), as specified under the applicable regulations;
- Certificate of Approval from Fraser Health Review Ethics Board;
- For more information regarding Fraser Health Research Ethics Board (FHREB) (e.g. FHREB fees, membership list, Federalwide Assurance (FWA) number, etc.) and harmonized research ethics process, see research ethics and other approvals.
- Clinical Trial Agreement (CTA);
- See below for a description and the approval process.
- Fraser Health Departmental Agreement for Providing Research-related Services form, if applicable.
- For more information, see related services to support your research.
- Letter of Authorization to Conduct Research (LOA) issued by Fraser Health’s Department of Evaluation and Research Services (DERS);
- LOA will only be issued if the other approvals have been completed.
What is a Clinical Trial Agreement (CTA)?
Clinical trial research funded by an industry sponsor or an academic institution requires a contract between the sponsor, the Fraser Health principal investigator and Fraser Health Authority. The Department of Evaluation and Research Services provides in-house CTA negotiation expertise with sponsors.
For Fraser Health investigators who are conducting an investigator initiated study, see research forms, guidance notes and templates for a CTA template.
What is the process for obtaining approval of clinical trial agreements (CTAs)?
- CTA is only negotiated if the application for ethical review has been submitted to the Fraser Health Research Ethics Board (FHREB) and the site has obtained the FHREB# for the study.
- The Fraser Health research site must submit the editable word document of the draft CTA and a completed Site Administration Form to the Department of Evaluation and Research Services (DERS) contract reviewer, whose contact information is listed in the form. The DERS contract reviewers will not review the CTA with incomplete information in the Site Administration Form.
Please note: It is the Fraser Heath research site’s responsibility to obtain an editable version of the CTA from the sponsor. The DERS contract reviewer will not accept the draft CTAs if submitted directly by the sponsor.
- The Fraser Health research site must ensure that all of their site’s requirements are included in the CTA prior to submission, e.g. investigator’s office address, payee information, investigator’s contact information for notices, etc.
- Fraser Health requires insurance certificates for all industry-sponsored research. The Fraser Health investigator must submit the sponsor’s insurance certificate to the DERS contract reviewer in order for the CTA to be signed off by Fraser Health.
- Budget may be developed by the research site in coordination with the sponsor while the CTA is being negotiated. If a study requires a new cost centre to be created to receive study sponsor’s payments, please indicate that a cost centre is required in the Site Administration Form.
Please note: For more information about cost centre, please see Grant administration for principal investigators and read the Research Accountability Guiding Document.
- Site Administration Form is reviewed for completeness. This form must be filled in by the research site completely in order for the DERS contract reviewer to start the CTA review. Accurate completion of the form will ensure that the correct administrative and payee information is included in the CTA.
- The DERS contract reviewer will conduct negotiations with the sponsor on behalf of Fraser Health.
- All correspondence with the sponsor is copied to the Fraser Health principal investigator and/or their assigned administrative contact, which is identified on the Site Administration Form.
Negotiation with the sponsor
- The DERS contract reviewer will notify the sponsor about required revisions. Negotiations will continue until all Fraser Health requirements are satisfied.
- The DERS contract approver will advise the research site if there are any concerns that require an executive decision prior to recommending acceptance of the CTA.
Prior to CTA finalization
The review and finalization of the study budget is conducted by the Fraser Health research site and the sponsor with input from DERS if applicable.
See “Is overhead collected for clinical trials?” below for a list of cost items that are subject to institutional overhead.
The Fraser Health research site reviews and approves the final CTA.
The Executive Director of Innovation, Research & Transformation reviews final CTA and insurance certificate(s) before beginning signature rotation.
The Executive Director of Innovation, Research and Transformation’s signature
- The sponsor notifies if electronic signatures are acceptable.
- If original signatures are required, then the sponsor sends the required copies directly to the DERS Program Assistant (address is included in the Site Administration Form). Minimum of three originals of the CTA are required.
- The Executive Director of Innovation, Research & Transformation signature will be obtained after Fraser Health Research Ethics Boards has issued the Certificate of Initial Approval.
Fraser Health principal investigator’s signature
- A partially signed CTA is sent by the DERS Program Assistant to the Fraser Health principal investigator for signing.
- Upon signing, the Fraser Health principal investigator is responsible for sending a copy of the signed CTA to the sponsor.
- The DERS Program Assistant will follow-up with the sponsor and the Fraser Health Principal Investigator until a copy of the fully executed CTA is returned to Fraser Health.
How to submit a Clinical Trial Agreement (CTA) amendment?
The research site must submit a completed Agreement Amendment Form to the DERS contract reviewer along with the amended CTA for review and sign off. The DERS contract reviewer will not accept the amended CTA if submitted directly by the sponsor.
Is overhead collected for clinical trials?
Institutional overhead fee is collected for all industry sponsored studies. The institutional overhead fee will apply to investigator-initiated studies whereby an industry funder is granted rights to inventions, discoveries, or study data in the research.
The Fraser Health research site must ensure that institutional overhead is applied on cost items that include, but is not limited to, the following:
- Start-up payments (including pharmacy start-up, lab start-up, radiology start-up fees)
- All per subject costs (including patients visits, unscheduled visits)
- Research coordinator activities (including time spent on screening, informed consent process, data entry, submitting protocol amendments, performing close-out activities)
- Screen failure reimbursements
- Medical procedures (including biopsies, radiological services, blood draws)
- Pharmacy fees (including dispensing of study medication, on-call pharmacist services)
The applicable annual institutional overhead fee to the Fraser Health research site is calculated based on the annual number of completed case report forms or the per patient cost (i.e., number of participants enrolled in the study). The Department of Evaluation and Research Services will email the Fraser Health research site and the principal investigator an invoice once a year at the time of Fraser Health Research Ethics Board annual renewal of the study until the study is closed. At study closeout, there will be a reconciliation process conducted to reconcile any over- or under-payments of institutional overhead.
Fraser Health support for investigator-initiated regulated clinical trial
The following support is facilitated by the Department of Evaluation and Research Services. Please contact the Clinical Trials and Business Development Manager for consultative assistance with the following:
- Preparation and submission of the Health Canada’s Clinical Trial Application
- Coordination of services from the Methodology Unit and Patient Oriented Research for the design and development research protocol
- Study feasibility assessments
Do I need to register my study on a clinical trial registry?
Per Health Canada’s notice, Health Canada encourages sponsors to register their clinical trials in publicly accessible registries such as ClinicalTrials.gov and ISCRTN. Health Canada reiterates registration on a clinical trial registry in the No Objection Letter (NoL).
Please contact the Clinical Trials and Business Development Manager if you need help registering your study in a public registry.
Research personnel training
The LearningHub provides classroom and online training services that is open to health care employees, physicians, students and volunteers at six BC health organizations and HEABC-affiliated organizations.
Available courses include, but not limited to:
- Fraser Health New Employee Required Learning
- Fraser Health Information Privacy and Confidentiality
- Fraser Health MediTech EMR for Research Staff
You can also sign-up for the Department of Evaluation and Research Services’ upcoming research workshops through LearningHub.
The Collaborative Institutional Training Initiative (CITI) – Canada Education Program
Through the Network of Networks (N2) membership, Fraser Health researcher and research staff has access to the CITI-Canada Program, which offers comprehensive courses on a variety of research related matters. The courses include a quiz after each module to test the learner’s knowledge. Following successful completion of the course, the learner is able to obtain a completion certificate. The research staff must file a copy of the completion certificate in the staff/site training log. This can be used to demonstrate compliance with the regulatory requirements for education in the respective topics.
- Good Clinical Practice Course
- Transportation of Dangerous Goods/International Air Transport Association (TDG/IATA)
- Health Canada Division 5: Drugs for Clinical Trials Involving Humans
- Biomedical Research Ethics Tutorial
- Social and Behavioral Research
- Responsible Conduct of Research – Life Science
How to register on CITI:
- Register and select Fraser Health Authority as your affiliate organization
- Fill in your name and email address
- Complete the user name and personal profile sections
- Select your courses
Network of Networks (N2) Standard Operating Procedures
In addition to the CITI-Canada Program, Network of Networks (N2) produces Health Canada compliant standard operating procedures (SOPs).
Please contact the Department of Evaluation and Research Services to access to the SOPs.
Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2: CORE)
Association of Clinical Research Professionals (ACRP) Learning Management System (LMS)
Vancouver Coastal Health Research Institute (VCHRI) and Clinical Trials BC have partnered with Association of Clinical Research Professionals (ACRP) to provide researchers and research staff across BC access to the e-learning library of educational courses free of charge.
If you are interested, contact Clinical Trials BC by sending a request along with your first and last name, email address and research location to email@example.com. Instructions on how to login and begin training will be provided within one week.
Other organizations providing professional development
Clinical Trials BC
Clinical Trials BC advances British Columbia’s development as a world-class destination for clinical trials across our province’s hospitals, research institutions and communities. Their mission is to maximize the health, educational, and economic benefits of clinical trials to the citizens of BC.
Clinical Trials BC, along with the BC SUPPORT Unit and Research Ethics BC, is a unit of the British Columbia Academic Health Science Network (BC AHSN).
Subscribe to their mailing list.
Clinical Research Professionals of BC
Clinical Research Professionals of BC (CRPBC) is an informal, inclusive group of over 750 Clinical Research Professionals who work in British Columbia. CRPBC provides networking and professional development opportunities for everyone working in the clinical research profession, grant funded or industry sponsored.
Subscribe to their mailing list.
Canadian Clinical Trials Asset Map (CCTAM)
Canadian Clinical Trials Asset Map (CCTAM) is a dynamic, online, searchable database listing Canada’s clinical research resources - clinical trial sites, research networks, institutions, universities, hospitals, REBs, CROs, industry, patient registries and organizations, and individual clinical research experts.
Patient-oriented research is a research that:
- Engages patients as partners (rather than patients as study subjects)
- Focuses on patient-identified priorities
- Is conducted by multidisciplinary team in partnership with stakeholders
- Aims to apply the knowledge generated to improve health care systems and practices
For more information, please visit the Strategy for Patient-Oriented Research (SPOR).
If you need help engaging patients in your research, contact the BC SUPPORT Unit Fraser Centre.
Clinical Trial Management System (CTMS)
Clinical Trial Management System (CTMS) is a research management platform that integrates and supports all the administrative aspects associated with running clinical research at the research site.
As a part of the provincial initiative involving BC health authorities and the BC Academic Health Science Network, the Department of Evaluation and Research Services is providing Fraser Health sites access to the system.
For more information, check out the CTMS info sheet.
If you have any questions, please contact the Clinical Trial Management System Coordinator.
Resources, forms and templates
- Research toolkit
Practical tools for new researchers and those who wish to improve their research knowledge.
- Clinical research start-up toolkit
Forms and templates that may be required to help preparing and conducting a regulated research.
- Research forms, guidance notes and templates
Forms required for ethics submission, research-related services and clinical trial agreements.
- Research toolkit