Articles tagged with “ich-gcp”

Learn the key differences between ISO 14155 for medical device trials and ICH GCP for pharma. This guide compares their scope, risk management, and regulatory c

Compare ACRP vs. SOCRA clinical research certifications. This guide analyzes eligibility, exam content (ICH GCP), cost, and recertification for CCRC, CCRA & CCR

Learn the key differences between an Adverse Event (AE), Serious AE (SAE), and SUSAR. This guide clarifies definitions, causality, and expedited reporting timel

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

Learn about clinical trial vendor management and how CROs ensure oversight of labs, logistics, and translation services per ICH GCP and regulatory standards.

Learn about the informed consent form (ICF), the cornerstone of ethics in clinical trials. This guide covers its history, regulations, and role in patient auton

A guide to the clinical trial protocol. 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. This guide explains eISF vs. eTMF, regulatory compliance, and benefit

Learn about the TMF Reference Model, the industry-standard taxonomy for organizing Trial Master File (TMF) documents in clinical trials for ICH-GCP compliance.