Division of Clinical Research

Office of the Vice President and Innovation

Category results for: COVID-19

New Free CITI Program Course COVID-19: Back to Campus (Fall 2020)

AAMC and CITI Program have collaborated to launch a complimentary course to train staff, students, and faculty on COVID-19 safety, for their return to campus. AAMC and CITI Program have collaborated to launch a complimentary course to train staff, students, and faculty on COVID-19 safety, for their return to campus. The course was made possible […]

Federal Government Issues warnings over threats to COVID-19 research

Recently, federal agencies (FBI and CISA) issued a PSA for awareness of threats involved in conducting COVID-19-related research. Targeting and compromising of U.S. organizations has been identified.   Activities observed include, attempting to identify and illicitly obtain valuable intellectual property (IP) and public health data related to vaccines, treatments, and testing from networks and personnel affiliated […]

COVID-19 testing for volunteers

See attached for more information for volunteering and testing sites during the COVID-19 pandemic at VCUHS.

FDA Issues Guidance for Industry, “Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency”

The FDA issued a guidance for industry entitled, “Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency.” The COVID-19 pandemic has impacted clinical development and ongoing clinical trials across investigational product areas. Public health measures to control the virus may impact the ability to collect data, for example, if trial participants are not […]

NEW FDA GUIDANCE: Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised)

FDA is issuing this guidance to provide a policy to help expand the availability and capability of non-invasive remote monitoring devices to facilitate patient monitoring while reducing patient and healthcare provider contact and exposure to COVID-19 for the duration of the COVID-19 public health emergency. This policy is intended to remain in effect only for […]

Institutional Review Board (IRB) Review of Individual Patient Expanded Access Requests for Investigational Drugs and Biological Products During the COVID-19 Public Health Emergency Guidance for IRBs and Clinical Investigators

(6/2/2020) – FDA is issuing this “Guidance for IRBs and Clinical Investigators” to provide recommendations regarding the key factors and procedures IRBs should consider when reviewing expanded access submissions for individual patient access to investigational drugs for treating COVID-19. See document here: https://www.fda.gov/media/138496/download

FDA Updates Question-and-Answer Appendix in Guidance on Conduct of Clinical Trials of Medical Products During COVID-19 Public Health Emergency

(6/3/2020) The U.S. Food and Drug Administration added content to the question-and-answer appendix in its guidance titled “Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency.” This guidance is intended for industry, investigators and institutional review boards. New QAs included: Q21. My company is the NDA holder of an FDA-approved drug for […]

FDA Updates Question-and-Answer Appendix in Guidance on Conduct of Clinical Trials of Medical Products During COVID-19 Public Health Emergency

(5/11/2020) The U.S. Food and Drug Administration added content to the question-and-answer appendix in its guidance titled “Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency.” This guidance is intended for industry, investigators and institutional review boards. New QAs included: Q18. I am a sponsor and would like to use an alternate […]

COVID-19 Rapid Research Funding

Early this month, we announced a VCU COVID-19 Rapid Research Funding Opportunity with support from the Office of the Vice President for Research and Innovation and the Wright Center for Clinical and Translational Research. Please use the link below to see who was awarded funding and for more information. https://orange.hosting.lsoft.com/list/ov8ia944/200429AU/3ewy3m17anmz.vib?a0=3040

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