Revolutionizing the Role of Quality Assurance in Clinical Trials
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Palricia W. Brown, PhD, ARNP Florida Hospital Heartland Division
Melissa P. Ball, BA The Catholic University of America Both authors were employed by Clinical euroscience Solutions Inc at the time this article was written. The ideas and processes weredeveloped during that time.
Revolutionizing the Role of Quality Assurance in Clinical Trials
Key Words Clinical drug trials; Quality assurance; Training
Correspondence Address Patricia IV. Brown. 1221 Lakeside Way. Sebring, FL 33876
INTRODUCTION The presen ce of a successful quality assurance (QA) pro gram is th e defining eleme nt in any orga nization th at separates the avera ge from th e excellent. The conce pt of QA epito mizes th e drive toward excellence in a world th at is becoming more compe tit ive eac h day.Most impor tant, it is a process that must e nsure th e subject's safety and, ultimately, se rves to improve th e quality of life of many by ensuring that the most efficacious drugs are brought to market. The importance of quality within clinical trials cannot be underestimated and should never be considered an afterthought, but should be systematically incorporated into th e site's development plan as well as th e development of its staff (1,2). This article is about the ever-increasing need for research ce nte rs to sophisticate trial management th ereby producin g quality outco mes. The application of proj ect mana gem ent techniqu es in clin ical trial s is a feature that has undergon e th e most developm ent and has shown th e most impact in pro viding usabl e result s in clini cal trial s. By instituting a rigo rou s QA pro gram , a site can e nsure learning, ad he rence, and deliverance of meaningful data. Gon e are th e days that QA is simply the sponsor's monitor visiting a site to ensure that the source and case report forms (CRFs) are com-
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As tile pharmaceutical industry continues to be pressured for reliable data from clinical drug trials. tile role and presence of quality assurance within a research site becomes paramount. The use of a structured quality assurance program can be usedto train and educate new clinical research coordinators and study physicians. In addition, this article aims to prepare the site for monitoring visits. as well as indentifyindividual personnel needs. or any site procedural concems. This article will outline a structured quality assurance program that was developed and utilized to periomi thesefunctions.
plete. Acomprehe ns ive approach to QA goes beyond merely appl ying auditing principles to clinical research. Responsibilities include submission s to regulatory authorities, compliance with laboratory practices, good clinical pra ctic es, and even goo d manufacturing pra cti ces and elec tronic co mpliance for larger firms. Routin e monitoring of th ese area s e ncourages co mpliance with regulation s and requirements as set forth in a site's standard operating pro cedures. However, if these function s are performed in a vacuum, the true impact of a QA system is lost. With proper ed ucation and tra inin
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