Descriptive Analysis of Good Clinical Practice Inspection Findings from the Saudi Food and Drug Authority Running Title: SFDA GCP inspections

Abstract

Introduction The Saudi Food and Drug Authority (SFDA) conducts inspections in accordance with Good clinical practice (GCP) to safeguard clinical trial integrity and protect the rights, safety, and welfare of study participants. These inspections ensure trials are conducted in compliance with GCP and applicable laws. Objectives The study aims to provide a description of GCP inspection findings and to analyze their impact on clinical trials ecosystems, and provide recommendations to improve clinical trial conduction in Saudi. Methods A review was conducted on inspection reports, with two senior independent inspectors examined, collected and categorized the data. Descriptive statistics were used to summarize the categorical variable by frequency distributions. Results A total of 131 GCP inspections were performed between 2017 and 2023. There was a total of 722 observations from 116 (88.5%) inspection visits, and the remaining 15 (11.5%) inspection visits had no observation. The highest number of visits were conducted in contract research organizations (CRO) (n=50; 38.2%) with 118 observations, followed by clinical investigator sites (n=46; 35.1%) with 313 observations, then bioequivalence centers (BE) (n=33; 25.2%) with 256 observations, and the last 2 (1.5%) visits were conducted in phase I clinical trials units with 35 observations. Conclusion This study assesses GCP inspection reports and examines the type of deficiencies and grades in each area. Observation findings category and grade vary by the type of organizations, which indicate the need for specific action plans addressing each organization type separately. This report provided recommendation based on the top most common findings to assist researchers and sponsors when conducting a clinical trial in Saudi Arabia.