Why Device, Diagnostic, and Digital Therapeutic Research Needs Endpoint Adjudication
In its March 2006 guidance, Establishment and Operations of Clinical Trial Data Monitoring Committees, the U.S. Food and Drug Administration
Reviews
Considerations for IRB Review: Artificial Intelligence & Machine Learning
Artificial intelligence in clinical research is expanding rapidly, bringing both excitement and ethical challenges. How can IRBs ensure responsible oversight?
DMC vs EAC: What’s the Difference?
Clinical research oversight relies on both DMCs for big-picture data review and EACs for detailed event assessments. Learn how each committee enhances trial safety.
Local Versus Central IRBs: What’s the Difference?
Central and local IRBs share the same research oversight goals, but NIH’s single IRB mandate challenges local IRBs to adapt their broader responsibilities.
Advarra’s Support for Institutions
As clinical research sites face more challenges than perhaps ever before, it’s increasingly important to provide sites with proper support
Planned Emergency Research and Exception from Informed Consent
Explore the regulatory criteria and ethical considerations for planned emergency research, including exceptions from informed consent (EFIC).
Beginner’s Guide to institutional review boards (IRBs)
In clinical research, institutional review boards (IRBs) a vital role in ensuring participant rights and ethical standards are upheld throughout the trial.
What Level of IRB Review Does Your Study Need?
Many research professionals do not realize that there are several different types of institutional review board (IRB) review. A study’s
Medical Devices: “Significant Risk” Versus “Nonsignificant Risk” Determinations
In medical device research, the determination of “significant risk” or “nonsignificant risk” is sometimes confusing, especially for those new to
Research Involving Cosmetics: What you Need to Know
The Food and Drug Administration (FDA) is a U.S. public health authority within the Department of Health and Human Services
Beginner’s Guide to Community-Based Participatory Research
With diversity, equity, and inclusion efforts currently at the forefront of the research community’s collective mind, we’re also seeing increased
Reporting to the IRB: What Does and Does Not Need to be Reported
Learn the essentials of IRB reporting, including why it matters, what’s required, what’s not, and tips to avoid common reporting challenges.