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

This study assesses GCP inspection reports and examines the types of deficiencies and their grades in each area. Observation categories and grades were found to vary by organization type, which indicates the need for specific action plans addressing each organization type separately. This report provided recommendations based on the most common findings to assist researchers and sponsors when conducting clinical trials in Saudi Arabia.

Authors

Institutions

Publication Details

Journal
Therapeutic Innovation & Regulatory Science
Published
2024-12-26
DOI
https://doi.org/10.1007/s43441-024-00731-5
Citations
2
Primary Topic
Ethics in Clinical Research
Type
article
Field-Weighted Citation Impact
1.09
Controls
|||
ALL TIME
JAN
FEB
MAR
APR
MAY
JUN
JUL
AUG
SEP
OCT
article

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

Omaima O. Arab, Jahad Alghamdi, Adel Alharf, Mohammed Aldayan et al.
2 citations
Therapeutic Innovation & Regulatory Science
Ethics in Clinical Research
1.09
article

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

Omaima O. Arab, Jahad Alghamdi, Adel Alharf, Mohammed Aldayan, Khalid Almowaizri, Ahmad Alghamdi
article en
2 citations

Abstract

This study assesses GCP inspection reports and examines the types of deficiencies and their grades in each area. Observation categories and grades were found to vary by organization type, which indicates the need for specific action plans addressing each organization type separately. This report provided recommendations based on the most common findings to assist researchers and sponsors when conducting clinical trials in Saudi Arabia.

Therapeutic Innovation & Regulatory ScienceVol. 59(2)
Saudi Arabian Monetary Authority (SA)
Openalex Percentile: Top 19%
Ethics in Clinical Research
1.09
AI Navigator

Ask Laika to Summarize, Analyze, and Connect papers live on the map.

Summarize Papers & Methodologies

Extract key findings, datasets, and comparative methods across publications.

Benchmark Rankings & Visual Analytics

Rank top research institutions, authors, funders, topics, and journals by Field-Weighted Citation Impact (FWCI) and paper volume with instant charts.

Connect Distant Disciplines

Bridge topological clusters on the map to find hidden collaborative intersections.