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
- Omaima O. Arab (ORCID: https://orcid.org/0000-0001-6647-5306)
- Jahad Alghamdi (ORCID: https://orcid.org/0000-0001-7261-8975)
- Adel Alharf (ORCID: https://orcid.org/0000-0001-8215-3198)
- Mohammed Aldayan
- Khalid Almowaizri
- Ahmad Alghamdi
Institutions
- Saudi Arabian Monetary Authority (SA)
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