Who is this for?
Sponsors, CRO's, Site Directors, Principal Investigators, Regulatory Specialists
What is the duration?
What can I learn from this?
- Balance patient safety with protocol compliance
- Adopt virtual or at-home visits as alternatives
- Document what actions you took and what impact they had on patient safety and data integrity
Advarra is the largest central IRB for pharmaceutical trials. Learn from Advarra's Vice President of Institutional Services what challenges the industry is facing; how to assess patient safety risks; what steps Advarra is taking; what specific actions sponsors and investigators should consider; and how to interpret the FDA's March, 2020 guidance on the covid crisis.
|Date:||March 24, 2020|
|Time:||12:00 AM EDT|
|Topic:||Clinical Trial Site Operations|
James has served on the board of the Northwest Association for Biomedical Research (NWABR) and the steering committee of the Clinical Trials Transformation Initiative (CTTI). He has also served as a site visitor for the Association for the Accreditation of Human Research Protection Programs (AAHRPP). In addition to being on the editorial board of the journal IRB Advisor and the leadership team for the Alliance for Clinical Research Excellence and Safety (ACRES) Committee on Accreditation, he is a faculty member, mentor, and regular speaker for Public Responsibility in Medicine and Research (PRIM&R) and other industry conferences.