Tag: ethics committee oversight

EMA Clinical Trial Audit Findings: Lessons for Sponsors and Sites

August 13, 2025

EMA Clinical Trial Audit Findings: Lessons for Sponsors and Sites Key Lessons from EMA Clinical Trial Audit Findings for Sponsors and Sites Introduction: The Role of EMA in Clinical Trial Oversight The European Medicines Agency (EMA), together with national competent authorities (NCAs), plays a central role in regulating clinical trials across the European Union. Since…

General Audit Findings in Clinical Trials, Regulatory Audit Findings

Fundamentals of the Informed Consent Process in Clinical Trials

June 10, 2025

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Fundamentals of the Informed Consent Process in Clinical Trials Understanding the Basics of the Informed Consent Process in Clinical Trials The informed consent process is a cornerstone of ethical conduct in clinical trials. It ensures that participants are adequately informed about a study’s purpose, risks, benefits, and their rights, before voluntarily agreeing to participate. This…

Informed Consent and Ethics Committees, Informed Consent Process

ICH-GCP Compliance: Principles, Responsibilities, and Best Practices for Clinical Research Integrity

May 4, 2025

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ICH-GCP Compliance: Principles, Responsibilities, and Best Practices for Clinical Research Integrity Mastering ICH-GCP Compliance for High-Quality Clinical Research Compliance with the International Council for Harmonisation Good Clinical Practice (ICH-GCP) standards is essential for ensuring ethical, scientifically credible, and regulatory-acceptable clinical research. ICH-GCP provides a globally harmonized framework that protects study participants while assuring the integrity…

Good Clinical Practice (GCP) and Compliance, ICH-GCP Compliance