A Statistically-Based Process for Auditing Clinical Data Listings
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Drug Information Journal. Vol. 31, pp. 647653. 1997 Printed in the USA. All rights reserved.
A STATISTICALLY-BASED PROCESS FOR AUDITING CLINICAL DATA LISTINGS ELLENM. SULLIVAN, MS Director, Quality Assurance
MARYANN GORKO,MS Project Biostatistician
RONALDC. STELLON,BA Senior Director, Quality Assurance
GEORGECHAO,PHD Executive Director, Biometrics DuPont Merck Pharmaceutical Co., Wilmington, Delaware
In October 1995, members of the DuPont Merck Biometrics and Quality Assurance staffs met to discuss improvements in the audit process for clinical data listings, With the advent of the International Conference on Harmonization (ICH) good clinical practices (GCPs), they were concerned about assuring that the procedures and processes for managing incoming clinical data and reporting to regulatory agencies were appropriately rigorous to ensure complete and accurate processing of clinical trial data. The following article describes a statistically-based audit plan that takes into consideration the phase of the trial, the importance of the trial to regulatory filings, and key study variables. The audit plan also includes a procedure for randomly selecting studies and patients for audit, and establishes statistically-based acceptance and rejection criteria. This audit process has been in use for sir months and has resulted in more eficient planning and execution of clinical data audits. Due to the randomness of the process and high standards f o r acceptable quality levels (AQL), internal quality control (QC) procedures have been strengthened to assure that all data listings meet these standards.
Key Words: Audit; Data listing; Acceptance criteria; Sampling plan; GCP
INTRODUCTION GOOD CLINICAL PRACTICE has become a globally accepted term for describing the standards of quality, ethics, and scientific rigor associated with the design, conduct, and reporting of clinical trials. Through the International Conference on Harmonization, the Food and Drug Administration (FDA) is participating with its regulatory and industry
colleagues in Europe, Japan, and the United States to establish a unified standard of GCPs ,_ ~
(1).
At the DuPont Merck Pharmaceutical Company (DMPC), representatives from Quality Assurance and Biometrics met to discuss ways to collaborate and improve the quality control and quality assurance (QA) processes associated with the internal management and reporting of clinical trial data. The primary focus of this meeting was to Reprint address: Ellen Sullivan, DuPont Merck Plaza, ensure the accurate and complete processing P.O. Box 80721, Wilmington. DE 198804721. of clinical data from the time of receipt by 647 Downloaded from dij.sagepub.com at NEW YORK UNIV LIBRARY on May 2, 2015
648
E. M. Sullivan, M.A . Gorko, R. C.Stellon, and G. Chao
Data that have been appropriately QCed by Biornetrics are locked and provided to Quality Assurance for audit. A decision to audit a locked database is determined by: the importance of the project and company expectations for product registration, and the clinical p
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