GCP/ICH Obligations: 12 Tips for Site Teams
ICH E6(R3) — effective July 2025 under EMA and published by FDA in September 2025 — is the most significant update to Good Clinical Practice in nearly three decades. While the guideline introduces a risk-proportionate, Quality by Design framework,
GCP/ICH Sponsors and Monitors: 15 Practice Questions
Under ICH E6(R3), the sponsor is the entity that takes ultimate responsibility for the initiation, management, and financing of a clinical trial. The monitor is the sponsor's representative at the site, responsible for verifying that the trial is
GCP/ICH Obligations of Investigators: Complete Guide
The principal investigator is the individual responsible for the conduct of a clinical trial at a site. Under ICH E6(R3) — the Good Clinical Practice guideline that came into effect on 23 July 2025 — the investigator's obligations span every phase
Financial Disclosure by Clinical Investigators Guide
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
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
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