ASK US Series: Archiving

12 January 2023

During the conduct of clinical studies, it is necessary to maintain an archive, whether paper or electronic, called the Trial Master File (TMF). This is the collection of essential documents used by sponsors, contract research organizations, and investigators for the management of the study. Health Canada reduced the retention period for clinical trial records for drugs and natural health products from 25 years to 15 years under the Food and Drug Regulations and Natural Health Products Regulations. This change took effect on February 11, 2022.

Join us in the 2nd episode of ASK US season three. Learn from an expert panel of representatives discussing the requirements of a compliant archive from: preparations, source locators, medium and transfers, archive breaks, institutional trackers and destruction. They will share a host of tips, quips and archive stories.

Date: Thursday, January 26, 2023

Time: 12 p.m. – 1 p.m. PST

 

 

Speakers:

Karen McGillivray Quality lead, Provincial Clinical Trials, BC Cancer

Karen is the Quality Lead, Provincial Clinical Trials at BC Cancer, responsible for quality oversight at 6 provincial centres. She has over 15 years’ experience in clinical quality and has previously worked for both a sponsor company and a CRO, allowing for a well-rounded view of Good Clinical Practices. Karen specializes in quality management and SOP creation, and conducted GCP audits both domestically and internationally. She has maintained her credential as a Registered Quality Assurance Professional in Good Clinical Practices since 2008.


Tara Martin – Clinical research manager, Djavad Mowafaghian Centre for Brain Health
Tara Martin is a research manager at the Multiple Sclerosis & Neuromyelitis Optica clinical trials department, located at the Djavad Mowafaghian Centre for Brain Health on UBC campus. She has accumulated over 20 years of experience conducting and overseeing clinical research studies. She is an ACRP certified clinical research coordinator with a Bachelor’s degree in Biopsychology from UBC. Tara is highly skilled in project and team management, currently managing a team of 12 research professionals. She has extensive experience with ethics submissions, clinical trial budgets, recruitment, archiving, regulatory compliance and Health Canada audit experience. Tara is committed to advancing medical treatments and improving patient outcomes through access to clinical research and ensures that the trials under her direction are conducted to the highest ethical standards.


Gurm DhuggaAssociate director, Research and Digital Technology, Faculty of Medicine, UBC
Gurm Dhugga is the associate director, Research & Digital technology, with the Faculty of Medicine Digital Solutions Group. Gurm is a senior IT leader with extensive experience supporting health research, working collaboratively with researchers to understand and develop digital infrastructure that meets broad scientific needs. Gurm has led the development of a digital service portfolio encompassing high-performance computing, clinical research systems, data management, application development, and integration. Gurm also has significant experience working collaboratively with the Provincial Health Services Authority (PHSA) and the University IT in supporting the Research and Education mission of UBC faculty. His education includes technical training in computer networking and systems from the BC Institute of Technology and a Masters of Business Administration from Simon Fraser University.

Tatiana Kawakami Privacy advisor research, Providence Health Care

Tatiana Kawakami holds a dual role of Privacy Advisor Research and Policy Advisor with Providence Health Care and Providence Research respectively. Tatiana is an ACRP certified clinical research, project management, and medical device professional with 15+ years of experience in delivering clinical research projects in North America, Europe, and Asia-Pacific. Her experience spans various functional areas: from contract negotiation, to “hands on” data acquisition, to establishing operational and quality management processes. Tatiana is committed to a patient-centered, ethical, and regulatory compliant approach to research and volunteers her time at different national committees supporting researchers across Canada.


Host:
Jean Smart – Regulatory affairs & quality officer, Clinical Trials BC; privacy officer, Michael Smith Health Research BC