Abstracts

RATIONALE: The clinical research environment is dynamically challenging with clinical trials becoming increasingly competitive and complex.It is imperative for clinical coordinators to keep abreast of audit requirements as the U.S. Food and Drug Administration (FDA) regulations are continually updated.
METHODS: Our center evaluated 2 comprehensive audits to evaluate any appreciable differences.The audits compared results between a 1993 audit and 2001 that were governed by FDA regulation updates.Once the clinical center is notified by the FDA,the pharmaceutical sponsor should be notified.The study coordinator involved in the primary research was the main contact individual for the FDA inspector.Study materials or patient charts not related to the current audit were removed from the conference room prior to the inspector[ssquote]s arrival.At the FDA[ssquote]s exit interviews, their findings were reviewed with the clinical study site.The site[ssquote]s post inspection meetings provided the entire staff opportunity to critically evaluate the results and formulate suggestions for improved data collection.
RESULTS: There was different emphasis between the audits and the way the materials were reviewed.The first audit in 1993,was held without sponsor assistance.The visit of the sponsor before the 2001,audit provided the site an opportunity to experience the review process.The sponsor offered tips and suggestions to enhance the inspection process.Essential methods include retain one copy for the center all the documents requested by the inspector.Document every question asked and the answer provided.It is imperative to be sure to clarify the inspector[ssquote]s question before responding,if there is any uncertainty,postpone the answer until further review.Each answer should be specific to the question without elaboration.The first audit was concerned with procedures and the data collected.The more recent audit focused on source documents,precise sequencing,and the center[ssquote]s overall protocol knowledge.One of the noticeable differences was documentation on the source documents.Signatures were required by everyone who wrote on the source document,and each persons involvement must be clearly distinguished.The clinical site must be aware of any revised FDA regulations that would affect the audit process.The inspector must use the version of regulation applicable during the time the study was performed,not at the time it is being audited.After each audit,our site updated Standard Operating Procedures,created new forms,and disseminated information through staff meetings.
CONCLUSIONS: The increasingly complex clinical research environment requires meticulous attention to detail,flexible adaptations to FDA regulations and a cooperative relationship between the investigator site,and the pharmaceutical sponsor or their representatives.