The US Federal Drug Administration released a new draft document titled ‘Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers” on March 12, 2023
New Article Unit: Clinical Trials BC
ASK JEAN column: copying or transfer of clinical trial records to a secondary medium
Questions: What is the definition of a true or certified copy in Canada? Are we allowed to transfer the Clinical Trial Essential Records from the original medium to another media during the study and at the time of archive?
ASK JEAN Column: direct access to source data and documents
Question: Do investigators and institutions have to provide direct access to source data and documents related to a clinical trial monitoring, REB review, audits, and regulatory inspection?
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Regulatory update: Winter 2023
Consultation has re-opened for the proposed agile regulations and guidance for licensing drugs and medical devices in Canada.
ASK US Series: Archiving
Join us in the 2nd episode of ASK US season three. Learn from an expert panel of representatives who will share a host of tips, quips and archive stories.
CTMS program updates: winter 2023
Check out the updates on BC’s provincially-harmonized Clinical Trial Management System (CTMS). Over the last year, our program has seen significant growth and progress.
CRP Certification Program: exam preparation sessions open for registration
Have you considered writing a clinical research certification exam with ACRP or SOCRA? We are hosting a series of exam preparation sessions in early 2023 to help you prepare.
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Clinical Trials BC and Pfizer partnered to deliver clinical trial training to BC researchers
On November 2, we collaborated with Pfizer Canada to deliver a clinical trial training workshop to over 300 investigators and research site team members across BC.
ASK US Series: Decentralized Trials & Research Alliance (DTRA)
Join us in the opener of ASK US Series season 3 with a special guest – Craig Lipset from the Decentralized Trials & Research Alliance (DTRA).
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Get certified as a Clinical Research Professional in 2023!
Clinical Trials BC continues to support those working in clinical trials to become certified clinical research professionals through funding, resources and examination preparation sessions.
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