02848nas a2200253 4500008004100000245007100041210006900112260001500181300001000196490000700206520208800213653001902301653000902320653002002329653001102349653001302360653001702373100002502390700002802415700003302443700002602476700002902502856006302531 2022 eng d00aResearch Policy of the Investigational Drugs in the Clinical Trial0 aResearch Policy of the Investigational Drugs in the Clinical Tri cApril 2022 a03-080 v113 a

Objectives: This study aims to explore the research policy of investigational drugs in the clinical trial as a new initiative in Saudi Arabia. Methods: This article is a narrative review of pharmacy research. Litterateur researched specific research policies and procedures in pharmacy practice using a variety of databases, including PubMed, Medline, and Google Scholar. The period covered for the search is from the 1960s to October 2021. The terms used are in the English language and encompasses narrative reviews, systemic reviews, meta-analyses, and guidelines. The search term encompasses all hospital and community pharmacy-related services. Besides, there are national and international guidelines for conducting general research in hospital practice. The pharmacy research committee was formed and comprised numerous expert members, including clinical pharmacists, pharmacists specializing in drug information, and clinical research specialists. A member drafted the policy’s guidelines, which were then reviewed and corrected by another member. The research specialist made the third revision. The subject emphasizes the research policy for investigational drugs in the clinical trial. Results: A general policy was established for investigational drugs in clinical trials, which included defining clinical trials and addressing related issues. Clinical trial approval policy, the role of the Institutional Review Board, the clinical responsibilities of the research team, and patient informed consent. Apart from that, clinical trials require patient records and auditing. Conclusion: The research policy for investigational drugs in a clinical trial is a novel initiative within pharmaceutical care research and development. The research policy for investigational drug in clinical trials protects patient rights and safety. Additionally, encourage pharmacy services to implement and conduct clinical trials in pharmacy practice at healthcare institutions of Saudi Arabia.

10aClinical trial10aDrug10aInvestigational10aPolicy10aResearch10aSaudi Arabia1 aAlomi, Yousef, Ahmed1 aAl-Najjar, Amal, Hassan1 aAbushomi, Hamidah, Qasim Ali1 aHusseinAlmadany, Maha1 aAlmasoudi, Abeer, Hussin uhttps://www.ijphs.org/article/2022/11/1/105530ijpcs2022112