You are here

Home
  • Overview
  • Instructors
  • Agenda
  • Contact
  • Location
January
18
Wednesday
  • 8:30 AM to 4:30 PM
  • Toronto General Hospital, Eaton North Building
    200 Elizabeth Street
    Toronto, ON
    M5G2C4


(Cost: $1800 plus HST)

Winter Session - January 18th, 19th, and 20th

How to Apply:
Contact QCIP@uhnresearch.ca for your application form!

The QCIP Foundations of Research Involving Humans course is an in-class training program primarily targeted to new Principal Investigators, Clinical Research Fellows, and Clinical Fellows who conduct research involving humans. The program includes a three-day foundations course, and is complemented by future advancement courses, which delve deeper into specific topics and applications of Good Clinical Practice principles. 

A certificate will be provided upon completion of the three-day foundations course, and upon completion of each advancement course. Learners who have completed all QCIP courses will also receive a Program Certificate.

QCIP - Quality Clinical Investigator Practices Program Overview.pdf

Our approach:

QCIP builds on the experiences of our learners through a case-based approach. This provides opportunities for learners to reflect on their current practice in clinical research conduct, develop and enhance knowledge of standards, identify challenges and barriers to the research process, and integrate a risk-mitigation approach to the conduct of research involving humans.

By using different learning formats and techniques, QCIP learners will be able to:

  • Assess and apply the evolving principles and practices of research ethics to the planning and conduct of research involving humans.
  • Identify the roles of Sponsors & Principal Investigators and apply regulatory requirements and external standards governing the Responsible Conduct of Research, and Good Clinical Practices.
  • Appraise relevant case studies and understand key concepts regarding research protocol development, risk identification, participant safety reporting, and protecting the privacy and confidentiality of research participants.
  • Recognize & prioritize potential challenges & barriers to the application of best practices in research.
  • Develop strategies to mitigate bias, maintain data quality, and ensure adequate supervision and oversight throughout the planning, conduct, recording, and reporting of research.

What others thought about the program:

“The program is well-planned with excellent small group learning and great discussions on conducting quality research. It's a great opportunity not only to learn and share experiences about research ethics and GCP but also to create important professional connections…I highly recommend my colleagues attend.” - Evelyn, Clinical Fellow

“The program’s activities and discussions really helped me work through different challenges in clinical research.  The program provided an international context to best practice that I can immediately apply to my work.” - Sojin, International Learner

“The facilitators did an excellent job at making the program engaging and I actually found myself enjoying learning about the intricacies of various research processes. Overall, I would highly recommend this program to anyone intending to undertake research at UHN.” - Karim, Physician & New Investigator

QCIP PROGRAM ADVISOR:

Dr. Deepali Kumar, MD, MSc, FRCPC
Associate Professor of Medicine, University of Toronto
Clinical Researcher, Toronto General Hospital Research Institute

Dr. Kumar is Associate Professor of Medicine at the University of Toronto in the Division of Infectious Diseases and Clinician-Investigator in Transplant Infectious Diseases and the Multi-Organ Transplant Program. Her clinical and research interests focus on emerging infections and the immunology of vaccines and viruses in the transplant population.  Dr. Kumar performs translational research and has both a clinical research and laboratory research program. She has done multiple investigator-initiated and industry-sponsored trials. She has received research awards including the Royal College Gold Medal in Medicine (2010), Research Excellence Awards from both the Canadian Society of Transplantation (2014) and American Society of Transplantation (2010).  She is board member of the American Society of Transplantation (AST).
 


QCIP PROGRAM FACILITATORS:

Siavash Ebbadi, MPH, BScH
Research Quality Associate, Research Quality Integration
University Health Network

Vash Ebbadi is a Research Quality Associate with the Research Quality Integration department, bringing with him more than 10 years of experience in clinical research and data analysis. Vash has worked collaboratively with numerous stakeholders at UHN to map and streamline processes around reporting, data collection and analysis, and clinical research studies. Additionally, Vash has written and implemented three investigator-initiated research studies at UHN and has trained over 100 personnel for clinical research studies and informed consent. Prior to joining Research Quality Integration at UHN, Vash completed a joint degree-diploma specialization programme in Industrial Microbiology at the University of Toronto obtaining an Honours Bachelor of Science and Diploma of Biotechnology. Vash has recently completed a Master of Public Health from the University of Waterloo.

Alexander Karabanow, BSc, BAA
Manager, Research Ethics Education and Coordinated Approval Process for Clinical Research (CAPCR)
University Health Network

As Manager for Clinical Research Support Systems at UHN, Alex Karabanow brings his extensive experience in research administration, Research Ethics Board (REB) operations as well as research ethics administration, education, process and systems improvement. He has been involved in the management of compliance, integrity, planning and communication activities both in healthcare and university environments. He is also an integral part of the team with the mandate to implement the Coordinated Approval Process for Clinical Research (CAPCR) system at UHN.  Alex is an REB Operations Expert representative on the Clinical Trials Ontario College of Reviewers and has played a leadership role at the Canadian Association of Research Ethics Boards (CAREB) as President and on the Board of Directors. He serves as an active member on several committees including the Toronto Academic Health Science Network (TAHSN) Board of Record Steering Committee, the RE2 (Research Ethics and Education) Committee at the Joint Centre for Bioethics (University of Toronto) and the N2 (Network of Networks) Education Committee/Collaborative Institutional Training Initiative (CITI)-Canada Developers Group.

Anita Sengar, BSc, CCRP
Manager, Research Ethics Services
University Health Network

Anita Sengar is the Manager, Operations, of the University Health Network (UHN) Research Ethics Board and offers extensive expertise from both the public and private sector. Anita has implemented metrics, systems and safeguards to ensure better compliance to global regulations and improved accountability for the institution as a whole.  Her previous work experience as both a member of the Clinical Trial Development Team and Lead Clinical Monitor has given her the necessary skills to manage the multiple aspects of research and with various therapeutic areas. Anita obtained her Bachelor of Science from the University of Calgary and holds certificates in SOP writing, GCP and Auditing.

Michael Voth, BSc, CQA
Manager, Research Quality Integration
University Health Network

Michael Voth is the Manager of the Research Quality Integration department at UHN, providing leadership in the planning, conduct and reporting of internal quality audits for clinical research. Michael has helped establish and build the audit programme and its procedures since its inception, providing a cooperative approach to auditing and quality improvement and strong knowledge in the following areas: research ethics, Good Clinical Practice, international drug and device research regulations (Health Canada, U.S. FDA, and EMEA) and standard operating procedure development. Michael has collaborated with research teams across a variety of therapeutic areas to support research subjects’ safety, data quality, and regulatory compliance. Prior to joining UHN, Michael completed a post-graduate certificate in Clinical Research from Humber College in Toronto, and a bachelor’s degree in biology from the University of Western Ontario. Michael is currently completing a M.Sc. in Public Health from the University of London School of Hygiene and Tropical Medicine.

Gianfranco Scipione, M.Sc., J.D./M.B.A., Barrister & Solicitor (Ont. 2010)
Research Integrity Associate, Research Quality Integration
University Health Network

Gianfranco Scipione is a Research Integrity Associate in the Research Quality Integration department at UHN.  Gianfranco brings to his role a wealth of experience and knowledge to the promotion of responsible conduct in research, the improvement of research integrity processes, and the fostering of excellence in research at UHN.  Research integrity often involves understanding and communicating expectations to support the dynamic scientific, legal, and business aspects of the biomedical research enterprise at UHN.  Prior to joining UHN, Gianfranco worked for Bata, an international foot wear manufacturer.  He worked alongside the Global Director of Innovation in building the Bata Innovation Lab and helped lead an organizational culture shift towards measurable, marketable and meaningful innovation within the organization.  Gianfranco’s educational background includes a B.Sc. in Biochemistry (2003), M.Sc. in Organic Chemistry (2006), and J.D./M.B.A (2009). He was subsequently called to the bar in Ontario in June 2010.  
 

DAY 1: Wednesday January 18th, 2017 | 8:30 AM - 4:30 PM

MORNING SESSIONS:

Program Introduction
Research Ethics
Good Clinical Practice

AFTERNOON SESSIONS:

Understanding the Regulatory Environment
The Research Protocol

DAY 2: Thursday January 19th, 2017 | 8:30 AM - 4:30 PM

MORNING SESSIONS:

Recap & Questions
Research Agreements
Assembling the Research Team

AFTERNOON SESSIONS:

Conducting Research Responsibly
Conflict of Interest

DAY 3: Friday January 20th, 2017 | 8:30 AM - 4:30 PM

MORNING SESSIONS:

Recap & Questions
Participant Recruitment & Informed Consent

AFTERNOON SESSIONS:

Participant Safety
Data, Documentation, & Privacy
Program Wrap-up

For further inquiries, please contact:


200 Elizabeth Street, 14EN-228
Toronto General Hospital, Eaton North Building
Toronto, ON
M5G2C4
T: 416.581.7805
E:info@medrist.ca
www.MedRIST.ca

Toronto General Hospital, Eaton North Building
200 Elizabeth Street
Toronto, ON
M5G2C4

Room No.: TBA

Wednesday, January 18, 2017 - 08:30 to Friday, January 20, 2017 - 16:30