Past CCCR Webinars
Title: Lessons learned from 2024 Regulatory Inspections
Date: Monday, January 13th, 2025
Presenters:
- Jenna Dobry, BSc, MSL, Lead Regulatory Officer - Clinical Research for the University of Calgary
Objectives:
- Understand the different regulatory agencies that conducted inspections last year
- Overview of 2024 inspection year with a focus on
- types of inspections
- purpose of inspections
- results & reporting
To view slide deck please see here
To view recorded webinar see here
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Title: Submitting a sublime application to the CHREB - tips and tricks
Date: Monday, February 24th, 2025
Presenters:
- Ashley Chan, BA, CCRP, Senior Research Ethics Analyst, CHREB
Objectives:
- Overview of the CHREB application
- the most common issues that we see on first submissions
To view slide deck please see here
To view recorded webinar see here
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Title: Open data sharing for populations at risk of re-identification
Date: Monday, March 24, 2025
Presenters:
- Dr. Stacey Page PhD, Associate Professor, Department of Community Health Services, Chair of the Conjoint Health Research Ethics Board
- Dr. Elizabeth Condliffe PhD, MD, FRCPC, Assistant Professor, Division of Physical Medicine & Rehabilitation
- Amanda Rande, MSc Research Coordinator
Objectives:
- Describe open data sharing to colleagues, potential participants and proxies.
- Evaluate the level of risk of re-identification for data.
- Discuss approaches for ethical, legally sound, open or partially open data sharing.
To view slide deck please see here
To view recorded webinar see here
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Title: Clinical Trial Budgets
Date: Monday, April 28th, 2025
Presenters:
- Asim Nadeem, B-Comm, DCMA, Manager, Clinical Research Business Services
Objectives:
- Gain a basic understanding of clinical trial budgets.
- Learn the role of the CCCR Finance Team.
To view slide deck please see here
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Title: AHS Navigating Health System Access Resources
Date: Wednesday January 24th , 2024
Presenters:
- Noopur Swadas, RN BN, Advisor | Health System Access | Health Evidence & Innovation | Alberta Health Services
- Leanne Blahut
Objectives:
- Understand the HSA Administrative Approval Process: From Start to Finish
- Explore Tools and Resources for Health Research via the Provincial Health System. SharePoint Platform within the Provincial Health System.
To view slide deck please see here
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Title: OnCore Financials Deep Dive
Date: Wednesday March 20th , 2024
Presenters:
- Mari Boesen, MSc PMP, CTMS Provincial Project Manager
Objectives:
- Understand the different charge types in OnCore and how to trigger them
- Be able to locate invoiceable items in OnCore
- Appreciate the differences between invoices from OnCore and invoices from PeopleSoft
To view slide deck please see here
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Title: AHS Biosafety for Research and Clinical Trials Policy
Date: Wednesday April 24th , 2024
Presenters:
- Joseph Roberts, Alberta Health Services Provincial Lead – Research Integration
Objectives:
- AHS has recently adopted a new Biosafety for Research and Clinical Trials policy. How research and clinical trials are reviewed and approved by AHS remains the same.
- This webinar discusses how the policy strengthens AHS’ ability to support Principal investigators using advanced interventions by:
- Complying with the federal Human Pathogens and Toxins Act and Regulations
- Applying a consistent approach to assess and manage biosafety and biosecurity risks, and
- Enabling trials whose sponsors require established procedures for biosafety review.
To view slide deck please see here
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Title: Electronic signatures in Adobe Sign & 21 CFR Part 11 Compliance
Date: Monday May 6th , 2024
Presenters:
- Jenna Dobry, Lead Regulatory Officer
Objectives:
- When to use Adobe Sign for electronic signatures in clinical research
- What are the 21 CFR Part 11 requirements
- How Adobe Sign meets these requirements with the new Bio-Pharma settings
- How the new settings have impacted sending a document for signature
- How the new settings have impacted signing a document
To view slide deck please see here
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Title: CSM Legal: IRISS Contract Module Adoption
Date: Monday October 7th, 2024
Presenters:
- Stephen Harris, Director and Senior Legal Counsel
- Manjari Shukla, Senior Contract Administrator
Objectives:
- Understand the reasons for transitioning to IRISS and its enhanced functionalities.
- Understand CSM Legal's agreement classifications and their purpose.
- Learn about common IRISS submission errors and how to avoid them.
To view slide deck please see here
To view recorded webinar please see here
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Title: Researcher's Guide to Clinical Trials at the University of Calgary
Date: Monday November 4, 2024
Presenter:
- Mari Boesen, MSc PMP, Provincial Project Manager, OnCore CTMS
Objectives:
- Know where to access the new Researcher's Guide to Clinical Trials at the University of Calgary
- Be able to explain the purpose and scope of the new guide
- Have a general understanding of the systems, teams, and processes for clinical trial workflows at the UC
To view slide deck please see here
To view recorded webinar please see here
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To view Past Lunch and learn Webinars and slide decks please click here
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Title: HOW TO …Save Time by Using OnCore System Integrations
Date: Monday January 30th, 2023
Presenter: Mari Boesen, Provincial CTMS Project Manager and Gillian Hughes, CTMS Implementation and Training Lead
Objectives:
- Become familiar with the existing IRISS, PeopleSoft, and Connect Care integrations
- Understand how CTMS integrations save time in research administration
- Learn about future integrations with OnCore
To view slide deck please see here
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Title: What's New at the Calgary Centre for Clinical Research
Date: Monday March 27th, 2023
Presenters:
- Gillian Hughes, Manager, Clinical Trial System Services, Provincial OnCore Support Team (POST)
- Asim Nadeem, Clinical Research Finance Lead
- Jenna Dobry, Quality Assurance and Regulatory Compliance Specialist
Objectives:
- The OnCore Clinical Trial Management System is becoming mandatory – find out what this means
- CCCR is taking over clinical trial invoicing – hear what is changing
- CCCR is offering monitoring – learn more about this new service
To view slide deck please see here
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Title: AHS Health System Access @ U of C
Date: Monday June 19th, 2023
Presenters:
- Noopur Swadas, RN BN, Advisor | Health System Access | Health Evidence & Innovation | Alberta Health Services
Objectives:
- Meet the HSA team
- Understand the role and function of HSA
- Learn tips to expediate your AHS administrative approval and ask questions!
To view slide deck please see here
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Title: Research in Connect Care Webinar
Date: Wednesday September 20th, 2023
Presenters:
- Wendy Pratch | Registered Nurse | Clinical Informatics Lead (CIL)
Objectives:
- Study in-take process (will emphasize the importance of responding to communications, etc.)
- Roles and Access
- Training Sequencing and Requirements
- Research Conversion
- Importance of the research icon
To view slide deck please see here
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HOW TO...Use The OnCore Clinical Trial Management System CTMS
Dec 12th, 2022
Speaker: Mari Boesen, Provincial CTMS Project Manager and Gillian Hughes, CTMS Implementation and Training Lead
Objectives:
- Understand how a CTMS facilitates study administration
- Learn about the core CTMS functionality and integrations
- Become familiar with the OnCore Happy Path
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HOW TO... Meet Research Data Management Requirements With The Help of The CRU
Nov 28th, 2022
Speaker: Chelsea Wellman, and Jesse Hart Szostakiwsky
Objectives:
- Outline the basic requirements detailed in the Tri-Agency Council's Research Data Management Policy.
- Discuss how the Clinical Research Unit (CRU) can support researchers to meet these requirements.
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HOW TO... Navigate CSM Legal for your Clinical and Non-Clinical Research Agreements
Oct 24th, 2022
Speaker: Sarah Menzies, Legal Counsel - Legal and Research services, CSM Legal
Objectives:
- New changes and improvements to the CSM Legal department
- Who is on the CSM Legal team and what do they do?
- Tips for researchers to facilitate faster agreement turn-around-times
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HOW TO... Utilize the AHS Research Pharmacy For Your Clinical Research
Sep 26th, 2022
Speaker: Candice Cameron BA, BSP, ACPR, Pharmacist, Pharmacy Research Service, Alberta Health Services – Calgary Zone
Objectives:
- To learn what services the AHS Research Pharmacy offers
- To learn how and when to engage the AHS Research Pharmacy
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HOW TO... Recruit for your Research Study
Speaker: Joslyn Gray, Project Manager, ACHIEVE Research
Objectives:
- will introduce effective ways to promote your research study
- demonstrate different strategies for recruiting into a research study
- produce examples of ways to increase participant retention
>>View Slide Deck >>View Webinar
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HOW TO …do remote consenting - Introducing the NEW REDCap eConsent Tool
May 30, 2022
Speaker: Chelsea Wellman, CRU Senior Project Coordinator.
Objectives:
- To provide an overview of eConsenting, its benefits and regulatory requirements
- To demo the NEW REDCap eConsent Tool
- To provide details on how to access the REDCap eConsent Tool
>>View Slide Deck >>View Webinar
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HOW-TO… Navigate the New IRISS AHS Module
April 25, 2022
The new AHS application module is now integrated directly within IRISS and replaces the previous SharePoint form.
The application is built on SmartForm logic and pulls information directly from the ethics application to guide study-specific.
Presenters:
Stacey Beck - Senior Consultant, Systems Dev, Office of Research Services, University of Calgary
Becky Wong – Director, Health System Access, Alberta Health Services
Key Features:
- visibility into the current state of your application
- ability to save, edit, and continue the application at any point
- automatic data sync with REB and AHS records so information is always current
- communicate directly with the AHS team through IRISS
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Demystifying Decentralized Trials - IQVIA’s Patient-Centric Decentralized Clinical Trial Solutions
February 28, 2022
This session was about Demystifying Decentralized Trials - IQVIA’s Patient-Centric Decentralized Clinical Trial Solution.
Presenter: Sylvie Cornibert, Strategic Site Solutions Manager, Strategic Site Solutions, US and Canada, IQVIA R & DS Operations
Learning objectives:
- Decentralized/Virtual Trials, where is it going?
- What does it look like now and likely to look like for the foreseeable future.
- Presentation of the IQVIA technology for Decentralized Trials What is the impact of Decentralized/Virtual Trials in general on site research staff?
>>View Slide Deck >>View Webinar
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"If we are all in this together, why do I feel *insert feeling here*?"
January 24, 2022
This session focused on mental health, wellbeing and discussions regarding examples and resources for you and your team. We understand that you and your team may be feeling *overwhelmed, guilty, unmotivated, resentful…* and we are here to discuss how to manage those feelings within yourself and your team. *This session was not recorded *
Facilitators:
- Michele Moon, MSc BScOT (she/her), Team Lead, WellBeing and WorkLife, Staff Wellness
- Amanda Habiak, RN, BN, OHN (she/her) Consultant, Mental Health, Staff Wellness
Learning Objectives:
- To recognize and identify the impact of the current circumstances and stressors on our selves, team and work.
- To explore a new and improved conceptualization of resilience.
- Find and use resources to help ourselves and others within our team.
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Health Research Platform Lunch & Learn, Nov 22, 2021
Title: Moral Distress, Compassion Fatigue and Burnout within your Research Team
Presenter: Daniel Garros, Clinical Professor, Dept. of Pediatrics, Div of Critical Care, University of Alberta, Stollery Children’s Hospital PICU
Learning Objectives:
- Describe old concepts: Moral Distress and Compassion Fatigue
- Explore new Concepts: Moral injury and Moral Hazard
- Apply the research results on Moral Distress into practice: how to resolve it
- How such ideas would help me solve nmy “angst” doing research in the present healthcare climate
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Health Research Platform Lunch & Learn, Oct 21, 2021
Title: Whistleblowing and Research Misconduct
Presenters:
Shirley Vonya Wilson, Protected Disclosure Advisor, Protected Disclosure and Research and Integrity Office, University of Calgary
Stacey Page, PhD, Chair, Conjoint Health Research Ethics Board, Associate Professor, Department of Community Health Sciences, Cumming School of Medicine, University of Calgary
Learning Objectives:
- to appreciate what research and scholarly integrity is and why is is important
- to understand what things are considered breaches of research and scholarly integrity
- to be aware of options and avenues to report concerns about research and scholarly integrity
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Health Research Platform Lunch & Learn, Sept 27, 2021
Title: Because ICH Says So
Presenter: Mari Boesen MSc PMP, CTMS Implementation Project Manager, Clinical Research, University of Calgary
Learning Objectives:
- appreciate the history behind clinical trial regulation
- explain how ICH came to be
- understand the importance of regulatory compliance
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Health Research Platform Lunch & Learn, Apr 26 2021
Title: Research Ethics Board Exchange (UA/UC multi site process)
Speakers:
- University of Alberta, Kim Kordov, Associate Director Research Ethics
- University of Calgary, Joan Fennell, Manager, Research Ethics & Compliance
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Health Research Platform Lunch & Learn, Feb 22 2021
Title: Patient Engagement in Health Research
Speakers:
- Maria Santana, Provincial Lead & Assistant Professor, Departments of Pediatrics and Community Health Sciences, University of Calgary
- Paul Fairie, Associate Director
- Sandra Zelinsky, Lead Patient Research Partner
- Sumedh Bele, Assistant Director
- Sadia Ahmed, Research Coordinator
- Ingrid Nielssen, Patient Engagement Coordinator Lead
- Tiffany Barbosa, Community Engagement Coordinator
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Health Research Platform Lunch & Learn, January 25 2021
Title: The Quality Assurance and Regulatory Compliance Program for Clinical Research: Lessons Learned
Speaker: Linda Longpré, CCRP, Quality Assurance and Regulatory Compliance Specialist, Calgary Centre for Clinical Research
Health Research Platform Lunch & Learn, November 30 2020
Title: Shared Investigator Platform Initiative at U of C
Speakers:
- Shweta Patel, Clinical Trial Program Administrator, Calgary Centre for Clinical Research (CCCR), University of Calgary
- Delaine Ramesh, SIP Implementation Strategy Lead CCO Canada, Hoffmann-La Roche Limited
- Suzan O'Donnell, Country Specialist/Shared Investigator Platform (SIP) Country Point Person, Hoffmann-La Roche Limited
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Health Research Platform Strategy Lunch & Learn, October 26 2020
Title: A Clinical Trial Management System for the U of C - A Game Changer in the Conduct of Clinical Trials
Speaker: Sabine Moritz, Director, Clinical, Health Services and Population Health Research
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Health Research Platform Strategy Lunch & Learn, September 28, 2020
Title: Running a Virtual Study: Lessons Learned from the Alberta HOPE COVID-19 Clinical Trial
Speakers:
- Mari Boesen, Associate Director, Pragmatic Clinical Trials Platform, Alberta SPOR SUPPORT Unit, University of Calgary
- Elizabeth Baguley, Research Administrative Assistant, Liver Unit, University of Calgary
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Have questions or comments?
Inquiries regarding education and training opportunities should be directed to Becca McInnes
Becca McInnes
cccr@ucalgary.ca