For Sponsors

Introduction

The University of Alberta has a legacy of advancing clinical research. The Clinical Trials Office (CTO) continues that mission by providing support services to investigators and industry partners conducting trials at the U of A. With over 600 active trials ongoing at the U of A, we have the capacity, facilities and expertise to bring success to any trial.

If you have any questions about starting a trial in collaboration with the U of A, please reach out here.

Clinical Trial Support Services

The CTO provides a broad range of support services for clinical trials at the U of A. We have deep roots within the research ecosystem and can facilitate connections between industry partners and researchers.

Industry Liaison Services

For Industry Partners Without U of A Contacts or Established Relationships

For Industry Partners With Existing U of A Contacts or Established Relationships

Diverse Clinical Trials Workforce

The CTO holds equitable access to clinical trial participation and fair distribution of results as a core value. We actively work to foster a diverse workforce within the scope of clinical trials. When people see themselves represented in principal investigators, study coordinators and other trial staff, they are more likely to participate. Let’s take a look at the numbers.

Contracts and legal review

CDAs, CTAs and other agreements are centrally reviewed by the institution’s legal team, on behalf of the investigator and sponsor. The CTO is available to assist with submissions for legal review.

Electronic Health Record - Connect Care

Alberta has a provincewide Clinical Information System (CIS) in place to manage the health information of patients. Investigators and industry partners can take advantage of this CIS called Connect Care, for clinical trials conducted through the U of A, and throughout Alberta. The robust data sets in Connect Care, access to participant’s health records, medication management and more can be requested for research.

Clinical Trials Management System (CTMS) - OnCore

OnCore CTMS is the provincial CTMS platform and is available for research conducted at the U of A. This system enables increased capacity for studies, standardization and adoption of best practices, and improved study quality, budget management, and regulatory compliance.

Regulatory, Quality Assurance & Clinical Trial Monitoring

The CTO is responsible for quality management in clinical trials at the U of A. We are available to assist investigators, biotech companies, university spin-offs/small industry, and medical device companies with regulatory submissions to Health Canada, design and implementation of quality assurance measures, and implementation of clinical trial monitoring for their studies.

Research Ethics Review

The U of A administers the Health Research Ethics Board (HREB) which is designated under Alberta’s Health Information Act to review research involving health information. The HREB holds a US Federal Wide Assurance and is the REB that reviews research funded by the U.S. Department of Health and Human Services, for instance NIH.

Research focused on the study of cancer or treatment of cancer patients is instead reviewed by the Health Research Ethics Board of Alberta Cancer Committee (HREBA-CC).

All research ethics applications at the U of A, except for cancer research, are prepared and submitted electronically using the Alberta Research Information Services (ARISE) system. Cancer research uses a parallel-integrated platform, Institutional Research Information Services Solution (IRISS).

Multi-site trials in Alberta can leverage the streamlined ethics application process called, REB Exchange (REBX). Applicants submit their studies for REB review in their respective REB platforms through the already established processes. Additional sites across Alberta can be linked to the approved study as participating sites, thereby reducing the administrative burden on these new sites. REB Exchange allows researchers to focus more time on conducting research by making study start up at multiple sites more efficient. This means more people can access research studies across the province, including in smaller centres where researchers may not have access to established research supports.

Frequently Asked Questions

Site Startup

Who can I contact for answers to our feasibility questionnaire?

For industry partners with established relationships, feasibility questionnaires can be provided to your existing U of A contacts.

For investigators or units that require additional support, or for organizations looking for collaborating U of A investigators, the CTO is available to connect research teams and facilitate completion of feasibility assessments. Contact us to learn more.

Other than the REB review, are there any other local approvals required?

For any studies requesting use of provincial health authority resources (e.g. Diagnostic Imaging, Pharmacy Research Office, clinic rooms), Operational Approvals for these resources must be requested. Administrative approval by the institution is also required prior to study start. These approvals can be initiated in parallel with the REB and legal submissions.

Can legal review and REB review occur in parallel?

Yes, REB submissions and contract review can occur concurrently.

Contracts and budget

How are the agreements (CDAs, CTAs, CUAs, etc) processed at your site?

Agreements provided to site staff are submitted into the legal review portal and are assessed by contracts specialists and legal counsel at the institution’s contracts department, NACTRC. The sponsor/CRO contact information is submitted along with the agreements and the contract specialists will contact the sponsor directly with questions. Electronic signatures will be obtained directly from the parties specified in the agreement, and the study team will be notified once the final execution has occurred.

Who can I contact to sign a Confidentiality / Non-Disclosure Agreement?

If your organization has established relationships with U of A investigators, the agreements can be sent to the research team who will then submit it for legal review. Electronic signatures will be obtained directly from the parties specified in the agreement, and the study team will be notified once the final execution has occurred.

For organizations looking for collaborating investigators the CTO is available to connect you with research teams and facilitate submission of confidentiality agreements for review and signature. Contact us to learn more.

How are study budgets processed at your site?

Individual investigators or research units (e.g. pediatric emergency medicine) negotiate their own budgets with industry partners. These budgets are then submitted to the legal review portal for inclusion in the finalized agreements.

For investigators or units that require additional support, the CTO is available to provide experienced budget consultation and negotiation on a cost-recovery basis. Contact us to learn more.

What are the timelines for agreement execution?

90-120 business days for high complexity, 45-90 for intermediate complexity and 1-38 for routine agreements. More information on the service times can be found here.

Research Ethics

Can the U of A use our sponsor-provided central REB for approvals?

No, the provincial privacy legislation in Alberta requires the board of record to be one of four local REB.

Will separate REB applications be required for adding additional sites in the province?

Yes, however through the use of the REB Exchange (REBX) platform, the workload and timelines for adding additional sites in Alberta is significantly reduced.

What is the meeting frequency for the local REB?

Meetings are generally held twice a month. More information about REB membership and submission requirements and meeting schedules can be found here.

Research Staff

Are research staff available to conduct our trial?

Yes, individual investigators or research units (e.g. pediatric emergency medicine) retain their own staff for the conduct of their trials. For investigators or units that require additional support, the CTO is available to provide experienced clinical trial coordination on a cost-recovery basis. Contact us to learn more.

Are research staff at the U of A GCP trained?

Yes, the CTO provides access to the CITI training platform for all U of A researchers. Training courses in ICH-GCP and Health Canada Division 5 are available, and completion certificates are provided.

Investigational Product (IP)

Are pharmacy services available?

Yes, operational approval for use of the Pharmacy Research Office can be requested on a cost-recovery basis.

Can your Research Pharmacy be the Importer of Record for the IP?

No, the Pharmacy Research Office cannot be listed as the Importer of Record under any circumstances and will not accept any shipping/custom charges.

What are the storage conditions for IP storage?

Studies using Pharmacy Research Office services have access to secure storage facilities with restricted access and documented fridge, freezer and room temperature recordings. Licensed pharmacists and pharmacy technicians are available to prepare and dispense IP according to the sponsor requirements. Further information is available in the Pharmacy Research Office SOPs.

Can IP be dispensed on evenings and weekends?

Yes, inpatient Pharmacy services for research can be accessed at the UAH 24 hours a day, 7 days a week.

Standard Operating Procedures (SOPs)

Does the U of A have SOPs for Clinical Research?

Yes, as a member of the Network of Networks (N2) the U of A provides a full suite of clinical trial SOPs to all U of A researchers conducting biomedical and clinical research. These SOPs have been reviewed by an expert regulatory consultant and are compliant with Health Canada and US Food and Drug (FDA) regulations, the ICH-GCP Guidelines and the revised Canadian Tri-Council Policy Statement on Research Involving Human Subjects.

The Pharmacy Research Office also maintains detailed SOPs for the handling, storage and dispensing of IP.

Informed Consent

Does the U of A require consent documents to be provided in a language other than English?

No, the REB does not require consent documents to be provided in languages other than english. However the CTO recommends preparing certified translations of participant facing documents, appropriate for the population being recruited.

Equipment and Facilities

Are we able to view the research facilities in person?

Yes, in-person visits to research areas (Research Pharmacy, Clinical Investigation Units, etc) can be arranged for industry partners and their representatives.

Can biological samples be stored frozen?

Yes, -20C and -70/-80C freezers are available through requesting laboratory services.

Can biological samples be analyzed locally?

Yes, common analyses can be requested locally from the laboratory services department on a cost-recovery basis.

Can biological samples be analyzed centrally?

Yes, samples collected onsite can be prepared and shipped (ambient or frozen) to most central laboratories.

Is the equipment calibrated and are records available?

Yes, equipment is maintained and calibrated in accordance with manufacturer guidelines and industry best practices. Documentation of calibration and maintenance are available on request.

Study Procedures

What phase(s) of studies can your site support?

The U of A has the capacity to conduct trials in Phases I through IV, and support research using Real World Evidence.

Does your site have the capacity for routes of administration other than oral?

Yes, studies at the U of A can request services from the adult and pediatric Clinical Investigations Unit (CIU). The nursing staff at the CIU are trained and qualified to administer common routes such as IV, IM, and others, as well as other nursing assessments. Individual study requirements can be discussed when requesting operational approval from the CIU.

Can imaging, ECGs and other assessments be done at your site?

Yes, imaging (X-ray, MRI, CT, TTE etc), ECGs and most common study procedures can be done onsite or at affiliated clinics. Contact your collaborating investigators with specific protocol questions for confirmation. If assistance is needed in connecting with investigators please reach out to the CTO for an introduction.

Can Pharmacokinetic-Pharmacodynamic (PK/PD) sampling be done at your site?

Yes, PK/PD sampling can be done onsite in the CIU. Contact your collaborating investigators with specific protocol questions for confirmation. If assistance is needed in connecting with investigators please reach out to the CTO for an introduction.

Is your site capable of all the protocol required assessments?

Individual investigators or research groups are better suited to answer questions about their experience with specialized protocol procedures such as disease evaluations or participant assessments. If assistance is needed in connecting with investigators please reach out to the CTO for an introduction.

Study Population

Individual investigators or research groups are better suited to answer specific questions about their patient population and catchment areas. If assistance is needed in connecting with investigators please reach out to the CTO for an introduction.

Regulatory

Who will sign the FDA 1572 form?

The U of A’s REB recommends that researchers ask clinical trial sponsors to exclude them from the US IND and that researchers decline to sign the US FDA Form 1572. In place U of A’s REB recommends that researchers provide a statement to the sponsor that verifies that the US FDA can validate the data from the Canadian site through an on‐site inspection. They can, if they desire, provide some form of an alternate assurance document, that confirms that the study will be conducted in accordance with domestic (Canadian laws), the ICH GCP E6, the protocol and the TCPS2. More information on the REB’s position on FDA 1572 forms can be found here.

Is approval from Health Canada required to start a trial at your site?

Yes, for studies falling under Health Canada regulation (e.g. new drugs or devices, off-label use, etc) documentation of approval is required for the REB approval.This is not a requirement for trials not regulated by Health Canada.

Monitoring

Can study monitors access the EMR?

Yes, study monitors can request access to the Connect Care Provider Portal. This

portal provides real-time web read-only access to patient information so external study

monitors can access patients' clinical data that is released by the study team.

What formats of monitoring visits can your site support?

Both remote and onsite monitoring visits can be done at our site. Remote monitoring can occur using external access to the Connect Care Provider Portal or by sending de-identified records. Individual investigators or research groups are better suited to answer specific questions about monitoring visit space and available resources.

If assistance is needed in connecting with investigators please reach out to the CTO for an introduction.

Have additional questions?

Contact the CTO and we will be able to direct you to answers.

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