Advancing Clinical Investigator Site Audits: A Quality-Focused, Risk-Based Approach
Clinical research is undergoing a profound transformation, driven by technological innovation, globalization, evolving regulatory expectations, and a growing emphasis on data integrity and subject protection. At the center of this evolution is the need for robust oversight mechanisms, especially for clinical investigator site audits, which serve as a cornerstone of Good Clinical Practice (GCP) compliance. […]
Learning from Recent FDA Warning Letters: A Call for Proactive Compliance
Every FDA Warning Letter offers more than a glimpse into individual noncompliance; it reveals systemic risks that can impact the safety of clinical trial participants, the reliability of study data, and the integrity of an organization’s quality systems. Between 2024 and 2025, several Warning Letters were issued that highlight critical—and recurring—compliance failures in drug and […]
Informed Consent: Getting It Right in Clinical Trials
Informed consent is one of the most vital elements of ethical clinical research. It serves not only as a regulatory requirement but also as a profound moral commitment to the autonomy, dignity, and well-being of every participant. But its meaning has often been misunderstood, reduced to a formality—a signature on a document—rather than the process […]
Beyond the Signature: Reexamining Informed Consent in Clinical Research
Informed consent in clinical research is often considered a regulatory checkbox, but it deserves far more attention. At its core, it’s an ongoing ethical commitment to transparency, respect, and protecting human participants. Yet too often, informed consent is reduced to paperwork. At Compliance Architects, we believe this critical process must evolve to meet the demands […]
100 Years of Consent: The History of Informed Consent & Why the Past Still Shapes Today’s Research Ethics
Informed consent is not a checkbox. It’s not merely a form signed and filed. It is a living, ethical, and regulatory process rooted in the foundational values of autonomy, transparency, and respect for individuals. As clinical research grows more complex and diverse, with digital platforms, decentralized trials, and global recruitment, the principles of informed consent […]
ICH E6(R3): Ushering in a New Era of Clinical Trial Oversight
In May 2023, the International Council for Harmonization (ICH) released the Step 2 draft of ICH E6(R3) for public consultation. This transformative update marks a significant milestone in the evolution of Good Clinical Practice (GCP). On May 22, 2024, the ICH announced the final Step 5 version of ICH E6(R3), a transformational update to the […]
Integrated Quality Assurance Systems: Clinical Trials
The notion that the role of Integrated Quality Assurance Systems in clinical development should be relegated to reviews, audits, and quality control (QC) checks is an old-fashioned one. This could well run medical product developers afoul of FDA and international regulations. The Role of Quality Assurance (QA) in Clinical Trials The role of QA in […]
MIT COUHES IRB Warning: Ensuring Compliance in Research
In the realm of clinical research oversight, adherence to regulatory standards is not merely a recommendation but a fundamental obligation. Recently, a significant development underscores this imperative, as the Massachusetts Institute of Technology’s Committee on the Use of Humans as Experimental Subjects (MIT COUHES) Institutional Review Board (IRB) received a warning letter from the FDA […]
