When a sponsor submits a marketing application to the FDA, the agency does not evaluate the clinical data in isolation. It considers who conducted the studies and whether any financial relationships between those investigators and the sponsor coul
EU Clinical Trial Regulation CTR 536/2014 Guide
On 31 January 2022, Regulation (EU) No 536/2014 (the Clinical Trials Regulation, CTR) became applicable across the European Union, replacing the Clinical Trials Directive 2001/20/EC. The CTR applies to all clinical trials on medicinal products for
Ethics in Clinical Research: 10 Practical Tips
Introduction Walk into almost any clinical research site and you'll find a binder, a shared drive folder, or an SOP titled something like "Ethics and Compliance." It's easy to file that material away mentally as background paperwork: necessary, but n
Ethical Review Boards: 15 IRB Practice Questions
Institutional Review Boards (IRBs), also known as Ethical Review Boards or Independent Ethics Committees (IECs) outside the United States, exist to protect the rights, safety, and welfare of people who take part in research. Before any clinical tr
Building an Audit-Ready Culture: How Clinical Sites Can Integrate Safety and Compliance Training
Clinical research sites are under constant pressure to follow strict rules, protect human subjects, and be ready for audits at any time. While written policies matter, what really builds a strong foundation is the daily behavior of staff. When safety
A Step-by-Step Guide to U.S. Regulatory Agencies in Clinical Trials: FDA, HHS and OHRP
Clinical trials play a vital role in testing new drugs, devices, and treatments. These studies help determine if medical innovations are safe and effective. But behind every trial is a network of federal agencies responsible for protecting the public
Holiday Season Risks in Clinical Trial Management: What CRCs Need to Watch Out For
The holiday season is a time of celebrations, travel, and time off, but for Clinical Research Coordinators (CRCs), it also brings a unique set of challenges. Clinical trials must run smoothly year-round, even when staff are on vacation, patients are
Workplace Ergonomics for Clinical Research Associates: Preventing Strain and Fatigue
WORKER SAFETY: Ergonomics Workplace Ergonomics for Clinical Research Associates: Preventing Strain and Fatigue Clinical Research Associates spend extended hours at laptops, in airport seating, at site office workstations that were not designe
Hazard Communication in FDA Workplaces: A Role-Based Overview
WORKER SAFETY: Hazard Communication Hazard Communication in FDA Workplaces: A Role-Based Overview FDA-regulated workplaces handle chemicals, biological materials, cleaning agents, and hazardous substances every day. Knowing what those substan










