Category: Uncategorized

Listening Session on the Digital Health Center of Excellence

The U.S. Food and Drug Administration (FDA) will host a virtual listening session for digital health device manufacturers, developers, health care providers, researchers, and other stakeholders to learn about the Digital Health Center of Excellence. During the session, the FDA will discuss the purpose and functions of the Center of Excellence and will focus on […]

New VCU IRB Notification

Please note that as of Sept. 28, the VCU Human Research Protection Program has revised the scope of human research data considered to be Private Health Information (PHI).  This scope has been narrowed to provide a closer interpretation of the HIPAA regulations, which helps to limit the institution’s liability if data breaches occur in a research […]

FDA virtual Town Hall for test developers on SARS-CoV-2

Oct. 7 from 12:15 – 1:15 p.m. On Wednesday, October 7, 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 test developers for SARS-CoV-2. During this Town Hall, the FDA will answer technical questions about the development and validation of tests […]

FDA Launches the Digital Health Center of Excellence

The U.S. Food and Drug Administration announced it is launching the Digital Health Center of Excellence within the Center for Devices and Radiological Health (CDRH). This center will further the agency’s dedication to the advancement of digital health technology, including mobile health devices, Software as a Medical Device (SaMD), wearables when used as a medical device, and […]

NEW Cerner Role for Clinical Research Coordinators

Mary Harmon, Alison Montpetit, and the Cerner team has developed a Cerner role that will give research coordinators the access needed as a researcher at VCUHS. Tickets have been placed with the Cerner team to have roles changed from All Retrieval Access to Care Coordinator EV. This allows coordinators to function more independently within the record. If […]

FDA Grand Rounds – October 8, 2020

CE Credit Available Presented by:Sam Raney, PhDLead for Topical and Transdermal Drug ProductsOffice of Generic Drugs, CDER, FDA About the Presentation:This presentation summarizes a series of FDA-coordinated, GDUFA-funded research studies included in a strategic multi-year, multi-million dollar research program to develop new, more efficient approaches by which to evaluate bioequivalence (BE) for topical generics. These […]

FDA OMHHE’s Clinical Trial Diversity free webinar

Tuesday, September 22 from 1:00 – 2:00 p.m. The FDA Office of Minority Health and Health Equity (OMHHE) at the U.S. Food and Drug Administration (FDA) presents a webinar featuring Drs. Barbara E. Bierer (Faculty Director, MRCT Center; Professor of Medicine, Harvard Medical School) and Luther T. Clark (Deputy Chief Patient Officer, Merck). Drs. Bierer […]

Apply for Fall Grant Academy by September 30

The Office of the Vice President for Research and Innovation is pleased to announce the Fall 2020 Grant Academy, a grant-writing program providing training and support for a select cohort of faculty investigators working with senior faculty, research-development experts, and research administrators, with the goal of submitting a successful funding proposal. Visit our website for […]

SOCRA Update: At Home CCRP Testing

SOCRA recognizes the difficult nature that COVID-19 has placed on members. Balancing work, home, and professional development has put a tremendous stress on clinical research professionals. In an effort to support membership and the clinical research community during these extraordinary times, SOCRA has implemented Home Proctoring to allow individuals to sit for the CCRP® exam remotely.  Home Proctoring […]

CDER SBIA Regulatory Education for Industry (REdI) Annual Conference

August 25-28, 2020 This workshop is free of cost. Register here. Interact with and learn directly from FDA’s regulatory experts in drugs and medical devices. This course is designed to provide participants with a strong, basic foundation in understanding the FDA’s drug and medical device regulatory requirements. Presentations include Q&A sessions. Please select the track […]

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