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 firstname.lastname@example.org. We will continue to provide newsflashes with information as it becomes available.
Management of clinical trials during the COVID-19 pandemic: Notice to clinical trial sponsors
FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic (Guidance for Industry, Investigators, and Institutional Review Board)
HealthCareCAN’s free member job postings now available until the end of April to all Canadian hospitals & research institutes
N2 members this message is courtesy of the Clinical Trials Transformation Initiative, who are hosting a webinar to identify best practices for conducting clinical trials with the new FDA guidance during the Covid-19 pandemic.
This week, stakeholders from across the clinical trials ecosystem submitted experiences and insights related to the FDA’s new guidance on the conduct of clinical trials of medical products during the current COVID-19 pandemic. The Clinical Trials Transformation Initiative (CTTI) collated the feedback – including insights on safety considerations, remote study visits, remote consent, consulting with IRBs, and more – and will share the findings and best practices via a webinar on Tuesday, March 31 at 11:15 a.m. EST.
M. Khair ElZarrad, FDA, CDER, will provide opening comments and a full discussion on the findings, along with detailed examples of best practices, will be presented by:
- David Borasky, WCG
- Sara Calvert, CTTI
- Cindy Geoghegan, Individual Patient Representative/Caregiver
- Colleen Rouse, Cleveland Clinic
- Pamela Tenaerts, CTTI
By exchanging best practices and insights, we can continue our important work to develop needed medical products during this situation, and perhaps even glean some opportunities to do clinical trials better, now and in the future.
Click here to register for the webinar