Articles tagged with “ich-gcp”

Updated for 2026: Compare ISO 14155:2026 for medical device trials vs ICH E6(R3) GCP for pharma. Covers scope, risk management, regulatory compliance, and the l

Compare ACRP vs. SOCRA clinical research certifications (updated April 2026). Covers ICH E6(R3) transition, eligibility, exam content, updated fees, and recertification for CCRC, CCRA & CCRP

Learn the key differences between an Adverse Event (AE), Serious AE (SAE), and SUSAR. Updated for 2026 with ICH E6(R3), EU CTR 536/2014 CTIS, FDA Dec 2025 guidances, and ICH E2B(R3) mandate. Covers definitions, causality, and expedited reporting timelines.

Explore the critical role of an IRB/IEC in protecting human subjects. Learn how ethics committees review and approve clinical trials per key ethical regulations including ICH E6(R3), the 2024 Declaration of Helsinki, and EU CTIS requirements

Learn about clinical trial vendor management and how CROs ensure oversight of labs, logistics, and translation services per ICH E6(R3) GCP and regulatory standards. Updated for 2026 with the latest on ICH E6(R3) implementation, decentralized trial logistics, and AI-assisted translation.

Learn about informed consent forms (ICFs) in clinical trials. Updated for ICH E6(R3) 2025, eConsent innovations, and FDA/EU regulatory changes. Covers history, ethics, and patient autonomy.

A comprehensive guide to the clinical trial protocol, updated for 2026 with ICH E6(R3) and ICH M11 developments. Learn its core components, importance in research, and how to manage complexity and amendments for successful trials.

Learn what an electronic Investigator Site File (eISF) is and its role in clinical trials. Updated for 2026 with ICH E6(R3) finalization, latest adoption data, and eISF vs. eTMF comparison

Learn about the TMF Reference Model (now TMF Standard Model under CDISC), the industry-standard taxonomy for organizing Trial Master File documents in clinical trials. Covers TMF SM v1, ICH E6(R3) alignment, and AI-powered eTMF automation.