N2 News

Provide Feedback to CTTI’s Draft Master Protocol Resources

Amid the COVID-19 pandemic, the value of master protocol studies has become clear: we need agile clinical trials that foster collaboration to address major public health threats and ongoing research challenges. You are invited to review and provide comments on draft resources created by the Clinical Trials Transformation Initiative (CTTI) to help drive the appropriate use of master protocols in diverse therapeutic areas. The resources include:

• Master protocols roadmap
• FDA engagement tool
• Business & operations plan template
• Protocol development template
• Vendor assessment tool

Click here to Provide Comments

As an important member of the clinical trials ecosystem, your feedback is important – please suggest revisions or additions to our draft resources by next Friday, April 24 at 11:59 p.m. ET. Your feedback will help shape the final materials that we make available to the public this summer.

Other important information:
• The open comment opportunity is only available in English.
• You may provide comments as an individual or an organization.
• There is no compensation.

COVID-19 Resources

We hope that you and your family are safe during this unprecedented time. N2 is collecting resources and information available related to COVID-19 and in particular clinical research. If you have any resources you would like to share with our larger N2 network please feel free to reach out to us at n2@n2canada.ca. We will continue to provide newsflashes with information as it becomes available.

Health Canada

Management of clinical trials during the COVID-19 pandemic: Notice to clinical trial sponsors

FDA

FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic (Guidance for Industry, Investigators, and Institutional Review Board)

HealthCareCAN

HealthCareCAN’s free member job postings now available until the end of April to all Canadian hospitals & research institutes

New Quality Committee Co-Chair!

N2 would like to give a warm welcome to Sasha Eskandarian from Hamilton Health Sciences as the new co-chair of the Quality Committee! Sasha, along with co-chair Jennifer Woo, will work with the Quality Committee and continue to support the N2 membership in quality matters.

Sasha Eskandarian has eagerly and proactively volunteered for the position of co-chair for our Quality Assurance Committee.  She is currently the Manager of Research Compliance and Support Services at Hamilton Health Sciences Corporation.  She possesses years of experience in the research field and is knowledgeable in quality assurance management.  She has managed complex global trials, has clinical monitoring experience and has a solid knowledge of national and international research environment and research ethics. Sasha is also very resourceful.  In this new role she has already reached out to Health Canada and has arranged for their occasional attendance on our monthly teleconferences.  She will be a great asset as co-chair to the committee.