MHRA Inspection Readiness: A Practical Guide for Clinical Research Teams

MHRA Inspection Readiness: A Practical Guide for Clinical Research Teams

"MHRA Inspection Readiness: A Practical Guide for Clinical Research Teams" is a comprehensive, hands-on resource designed for clinical researchers, study coordinators, sponsors, and site staff preparing for UK Medicines and Healthcare products Regulatory Agency (MHRA) inspections. Covering every stage of inspection readiness— from Trial Master File (TMF) and Investigator Site File (ISF) organisation to CAPA management, vendor oversight, and digital system audits— this book offers practical tools, templates, and checklists to help research teams achieve full compliance. Learn how to handle unannounced visits, master documentation standards, respond effectively to inspection findings, and stay aligned with Good Clinical Practice (GCP) and ICH E6(R3) guidelines. Whether you’re working in a single-site or multi-site trial, this guide equips you with the confidence and resources to pass inspections successfully and maintain high-quality, inspection-ready trials at all times.