A statistically-based process for auditing clinical data listings

Drug Information Journal

Volumn 31, Issue 3, 1997, Pages 647-653

  Sullivan, Ellen M ^a   Gorko, Mary Ann ^a   Stellon, Ronald C ^a   Chao, George ^a  

^a DUPONT COMPANY   (United States)

Author keywords

Acceptance criteria; Audit; Data listing; GCP; Sampling plan

Indexed keywords

ARTICLE; DATA ANALYSIS; GOOD CLINICAL PRACTICE; INTERNATIONAL COOPERATION; MEDICAL AUDIT; PRIORITY JOURNAL; QUALITY CONTROL; SAMPLING; STATISTICAL ANALYSIS;

EID: 0030743174     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286159703100304     Document Type: Article

References (2)

1. Guidance for Good Clinical Practice, ICH EWG EG: Good Clinical Practice Version: May, 1996.
2. Duncan AJ. Quality Control and Industrial Statistics. Third Edition. Homewood, IL: Richard D. Irwin, Inc.; 1965:145-160.