A Practical Guide to Study Directing
Alan P. Brown
Drug Safety Research & Development, Pﬁzer Global Research & Development, Ann Arbor, Michigan48105, USA
The Good Laboratory Practice (GLP) regulations are designed to provide regulatoryguidance and oversight of nonclinical studies that prospectively study the effects oftest articles in test systems under laboratory conditions to determinetheir safety. Theseregulations are designed to assure quality, accountability, and reliability of safety data,and provide guidelines for improving the scientiﬁc validity of the studies. A key ele-ment of the GLP regulations is with respect to the role of the Study Director, who is theindividual assigned as the single point of study control and has overall responsibilityfor the entire nonclinical study. Experience has shown that unless responsibility for theproper conduct of a study is assigned to a single individual, the potential exists forpersonnel to receive conﬂicting instructions, and for study events and issuance of theﬁnal report to occur in an uncoordinated fashion. While serving as the Study Directorcan be a challenging position with numerous demands and expectations, it is a rolethat allows an individual the opportunity to combine project management withtechnical and scientiﬁc skills in the pursuit of a single goal. Individuals who serve asStudy Directors in the nonclinical laboratory typically represent a diverse range ofeducational and professional backgrounds, and oftentimes learn to become StudyDirectors on the job. The goal of this paper is to provide a concise description of theStudy Director’s responsibilities and give guidance for planning, initiating, and com-pleting a nonclinical study. While this paper focuses on test articles that are evaluatedin the pharmaceutical/biotechnology industry and regulated by the US Food and DrugAdministration (FDA) GLPs, much of the information presented should apply to otherGLP and non-GLP studies. Copyright
2009 John Wiley & Sons, Ltd.
Study Director; GLP; Good Laboratory Practices; nonclinical laboratory;toxicology; US FDA
Introduction and Responsibilities
The US FDA Good Laboratory Practice (GLP)regulations (Section 58.33) state the following.‘‘For each nonclinical laboratory study, ascientist or other professional of appropriateeducation, training, and experience, or combi-nation thereof, shall be identiﬁed as the StudyDirector. The Study Director has overallresponsibility for the technical conduct of thestudy, as well as for the interpretation, analysis,documentation and reporting of results, andrepresents the single point of study control. TheStudy Director shall assure that:
*Correspondence to: Alan P. Brown, PhD, DABT,NAMSA Inc., 6750 Wales Road, Northwood, Ohio,USA. E-mail: email@example.com
Qual Assur J
, 40–50DOI: 10.1002/qaj.438Copyright
2009 John Wiley & Sons, Ltd.