Clinical Trials Office
Source: https://cumming.ucalgary.ca/research/cccr/clinical-trials-office Parent: https://cumming.ucalgary.ca/
Access clinical trial support services and resources - all in one place.
We're here to support your clinical trials
Welcome to the new Clinical Trials Office (CTO). The CTO is a sub-unit of the CCCR, established to provide University research staff with centralized access to clinical trial services and resources. The office serves as the initial point of contact and primary coordinating office for clinical trials conducted at the University, bringing together all expertise in one place: regulatory, financial, operational and more.
In addition to the Clinical Trial Services listed below, our office collaborates with the Provincial OnCore Support Team (POST) to deliver OnCore-related services and support.
Clinical Trial Services
The CTO provides dedicated support for industry sponsored and investigator initiated trials from start-up to close-out. In addition to support services, the CTO provides leadership and guidance through tailored project consultations and access to a research concierge to help navigate the University clinical trial ecosystem. You can view an alphabetical service listing here.
The Clinical Trial Guide for Industry Sponsors. The purpose of the guide is to provide an overview of clinical trial services at the University of Calgary and to address the questions industry sponsors commonly asked during Site Selection Visits.
Before the trial
- Coordination of all trial start-up activities
- Supporting and planning site selection/initiation visits including providing aClinical Trial Guide for Industry Sponsors addressing questions commonly asked during Site Selection Visits.
- Assisting with the development of trial contracts and agreements
- Developing, reviewing and negotiating trial budgets
- Budget review: a no cost budget analysis and consultation for research teams
- Budget negotiations: offered at no cost, the CCCR (in collaboration with the research team) negotiates an optimal budget with the study sponsor. Research teams have the option to conduct their own budget negotiations; however, the negotiated budget is subject to CCCR approval.
- Conducting regulatory reviews and coordinating Health Canada submissions
- Providing AHS and Industry Liaison support
- Conducting pre-award budget reviews
- ClinicalTrials.Gov submission
During the trial
- Facilitate sponsor site assessments and monitoring
- Provide regulatory guidance, perform regulatory oversight and help with preparations for audits and inspections
- Coordination of third-party payments (including AHS Service Payments)
- Assistance with trial budget management and renegotiating of budgets when necessary
- Assistance with sponsor invoicing and payment reconciliation for studies managed in OnCore (coming soon)
After the trial
- Coordination of trial closure activities
- Archiving of study documents and records
- Reconciliation of financial accounts
AHS Liaison Services
AHS Liaison Services are available to researchers and study teams who need to engage with AHS to conduct clinical trials.
Services include:
- Acting as a point of contact for questions regarding AHS facilities, resources and requirements.
- Serving as the institutional experts on important AHS initiatives - including the ConnectCare rollout.
- Support and training for the EPIC platform (including account creation and ongoing support).
Can't find what you're looking for?
Contact the Research Navigator
The CCCR Research Navigator provides a higher-level of support to investigators and study teams. As we offer services that may not be listed on this website, our Navigator can provide project-specific guidance to identify relevant services or connect you to other University support teams as required.
Quality Assurance for Clinical Trials
The CCCR also provides Quality Assurance (QA) and Regulatory Compliance services for the research community to ensure that all clinical research meets high-quality standards and ICH Guideline for Good Clinical Practiceare followed.
Request services
To request clinical trial support services or connect with an expert to discuss your needs, contact our office.