IRB
FDA Inspections of Clinical Investigators: Understanding the Process and What to Expect
A Food and Drug Administration (FDA) inspection of a clinical investigator can occur at any time. The FDA conducts inspections of clinical investigators to verify clinical trial data submitted to FDA; to ensure that the rights, safety, and welfare of human subjects enrolled in FDA-regulated clinical trials are protected; and to assess regulatory compliance.
James Riddle and Luke Gelinas Explore Digital Health and Regulation
This podcast covers an array of topics as they explore how COVID has been a catalyst for change, what digital health means for running clinical trials, and how sponsors, CROs, sites, and IRBs can consider when reviewing new digital technologies as a result of COVID.
Leveraging a Central IRB Office to Improve Turnaround Times and Consistency
Legislation to Advance Equality and Inclusion in Oncology Clinical Trials
The Clinical Treatment Act and Henrietta Lacks Enhancing Cancer Research Act aims to increase diversity in oncology clinical trials
Biosafety, Ethical, and Logistical Challenges to Pursuing a Coronavirus Vaccine at Warp Speed
The SARS-CoV-2 pandemic has impacted all aspects of society. Various government and private groups around the world are endeavoring to develop safe and effective vaccines at an unprecedented pace and scale to quell the pandemic as quickly as possible.
Central IRB Review for Institutional Sites: A Toolkit for Sponsors and CROs
Q&A: Institutional Responsibilities Under a Federalwide Assurance
Q&A from the Institutional Responsibilities Under a Federalwide Assurance (FWA) webinar and an overview of the FWA and its changes with the revised Common Rule.
Understanding the Complexity and Uniqueness of Phase I Trials
There are many distinctions that set Phase I trials apart from the rest. For sites aiming for a successful Phase I trial, working with an organization that understands the nuances is key.
Top 10 Educational Resources of 2020
We strive to create meaningful and relevant content for the clinical research community. Check out our top resources of 2020.
New FDA Certificate of Confidentiality Guidance: What Does it Mean for You?
Certificates of Confidentiality protect participant privacy by preventing disclosed sensitive information during research.
Community-Based Participatory Research (CBPR): A Framework for Community Engagement
Community-based participatory research (CBPR) is utilized to reduce racial and ethnic health disparities in under-represented populations.
The Many Faces of “Coercion” and “Undue Influence”
Coercion and undue influence in research can be complicated. Understand what these terms mean and how to appropriately protect against them.
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