COMPUTERIZED SYSTEMS USED IN CLINICAL TRIALS

U.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Biologic Evaluation and Research (CBER)Center for Drug Evaluation and Research (CDER)Center for Devices and Radiological Health (CDRH)Center for Food Safety and Nutrition (CFSAN)Center for Veterinary Medicine (CVM)Office of Regulatory Affairs (ORA)
April 1999


TABLE OF CONTENTS
I. INTRODUCTION *
II. DEFINITIONS *
III. GENERAL PRINCIPLES *
IV. STANDARD OPERATING PROCEDURES *
V. DATA ENTRY *
A Electronic Signatures *B. Audit Trails *C. Date/Time Stamps *
VI. SYSTEM FEATURES *
A. Facilitating the collection of quality data *B. Facilitating the inspection and review of data *C. Retrieval of Data *D. Reconstruction of Study *
VII. SECURITY *
A. Physical Security *B. Logical Security *
VIII. SYSTEM DEPENDABILITY *
A. Systems documentation *B. Software validation *C. Change Control *
IX. SYSTEM CONTROLS *
A. Software Version Control *B. Contingency Plans *C. Backup and Recovery of Electronic Records *
X. TRAINING OF PERSONNEL *
A. Qualifications *B. Training *C. Documentation *
XI. RECORDS INSPECTION *
XII. CERTIFICATION OF ELECTRONIC SIGNATURES *
XIII. REFERENCES *

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