Category: COVID-19

January 2021 COVID Guidance

Guidance for VCU clinical research teams as COVID-19 cases rise Due to significant increases in COVID-19 cases at VCU Health and throughout our community, OVPRI offers new, additional guidance essential for the safe conduct of clinical research. Learn more at conta.cc/2KZ3dBh. Guidance essential for the safe conduct of human subjects research studies   OVPRI offers guidance for […]

Guidance for Clinical Research Teams as COVID-19 Cases Rise

Due to significant increases in COVID-19 cases at VCU Health and throughout our community, we are sharing additional guidance essential for the safe conduct of clinical research during unpresedented challenges to our healthcare infrastructure: Actively support the safety and wellbeing of your research participants given the rapidly evolving conditions of the pandemic. Evaluate the potential for added […]

VCU Health system COVID-19 information – clinical research team members

In response to the Virginia Occupational Safety and Health (VOSH) Program and Virginia Department of Labor and Industry (DOLI) Emergency Temporary Standard related to COVID-19, VCUHS is providing education on PPE requirements and risks associated with COVID-19 transmission on the VCU Health COVID19 Intranet Site. Please complete the following RedCap survey if possible. Link:   https://redcap.vcu.edu/surveys/?s=E4RPFDNN3F

HHS Office of Minority Health Hosts Virtual Symposium on COVID-19

Advancing the Response to COVID-19:Sharing Promising Programs and Practices for Racial and Ethnic Minority CommunitiesA Virtual Symposium Hosted by the HHS Office of Minority Health September 17, 2020 from 12:00 PM to 6:00 PM ET The U.S. Department of Health and Human Services (HHS) Office of Minority Health (OMH) is hosting a virtual symposium on Thursday, September […]

FDA Virtual Town Hall for Labs and Manufacturers on Coronavirus (COVID-19) Diagnostic Tests

On Wednesday, September 2, 2020, from 12:15 pm – 1:15 pm Eastern Time, the U.S. Food and Drug Administration (FDA) will host a virtual Town Hall for clinical laboratories and commercial manufacturers that are developing or have developed diagnostic tests for SARS-CoV-2. During this Town Hall, the FDA will answer technical questions about the development […]

OMH Virtual Symposium on COVID-19

Registration is now open for Advancing the Response to COVID-19: Sharing Promising Programs and Practices for Racial and Ethnic Minority Communities, a virtual symposium hosted by the U.S Department of Health and Human Services (HHS) Office of Minority Health (OMH) taking place on September 17, 2020. Join us to learn from national, state, tribal and local experts […]

Webinar on FDA’s Regulation of Face Masks and Surgical Masks During the COVID-19 Pandemic

On Tuesday, August 4, 12:00 p.m.-1:00 p.m. ET, the U.S. Food and Drug Administration (FDA) will host a webinar on the FDA’s regulation of face masks and surgical masks during the COVID-19 pandemic. This webinar will expand the scope of the respirator webinar series to discuss face masks and surgical masks. During this webinar, representatives […]

August Dates Announced for the FDA’s Virtual Town Hall for Labs and Manufacturers on Coronavirus (COVID-19) Diagnostic Tests

In August, the U.S. Food and Drug Administration (FDA) will continue hosting virtual Town Halls for clinical laboratories and commercial manufacturers that are developing or have developed diagnostic tests for SARS-CoV-2 on the following dates: August 5, 2020 from 12:15 pm – 1:15 pm Eastern Time August 12, 2020 from 12:15 pm – 1:15 pm […]

How FDA is Working to Facilitate COVID-19 Treatments

When the FDA learned of the novel coronavirus (COVID-19) and its potentially devastating effects, we acted swiftly to set the regulatory stage for drug and biologics manufacturers to develop products to treat this serious disease. To meet this urgent need, the FDA created the Coronavirus Treatment Acceleration Program (CTAP) to enable the FDA’s Center for […]

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

(7/2/2020) The U.S. Food and Drug Administration updated 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. The updated guidance clarifies two previously suggested methods for obtaining informed consent from a hospitalized […]

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