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
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.
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.