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Home » Clinical: Pharmaceutical » Page 2

Clinical: Pharmaceutical

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June 16, 2026
by VelSafe Editorial Team Law

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

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ethics-foundation-clinical-research-tips
June 15, 2026
by VelSafe Editorial Team Tips

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

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irb_v3
June 15, 2026
by VelSafe Editorial Team Practice Tests

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

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Building an Audit-Ready Culture How Clinical Sites Can Integrate Safety and Compliance Training
July 20, 2025
by VelSafe Editorial Team Worker Safety

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

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A Step-by-Step Guide to U.S. Regulatory Agencies in Clinical Trials FDA, HHS and OHRP
July 16, 2025
by VelSafe Editorial Team Guides

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

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Holiday Season Risks in Clinical Trial Management What CRCs Need to Watch Out For
July 5, 2025
by VelSafe Editorial Team Situational

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

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Workplace ergonomics for clinical research associates featured image showing a female CRA working at a laptop on a stand at a clinical site visit workstation, with ergonomic posture annotations for neutral neck, back support, arm position, and foot placement, and an OSHA 29 CFR 1910 ergonomics requirement note.
July 5, 2025
by VelSafe Editorial Team Worker Safety

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

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Hazard Communication in FDA Workplaces A Role-Based Overview
June 29, 2025
by VelSafe Editorial Team Worker Safety

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

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