Descriptive Analysis of Good Clinical Practice Inspection Findings from the Saudi Food and Drug Authority.

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 that trials are conducted in compliance with GCP and applicable laws.

Objectives

The study aims to provide a description of GCP inspection findings, analyze their impact on the clinical trial ecosystem, and provide recommendations to improve clinical trial conduction in Saudi Arabia.

Methods

A review was conducted on inspection reports, with two senior independent inspectors examining, collecting, and categorizing the data. Descriptive statistics were used to summarize the categorical variable via frequency distribution

SUBMITTER: Arab OO 

PROVIDER: S-EPMC11880033 | biostudies-literature | 2025 Mar

REPOSITORIES: biostudies-literature