Open AccessData Integrity in the Pharmaceutical Industry: Analysis of Inspections and Warning Letters Issued by the Bioresearch Monitoring Program Between Fiscal Years 2007–2018
Author(s) -
Clinton A. Rogers,
Jennifer D Ahearn,
Michael G. Bartlett
Publication year - 2020
Publication title -
therapeutic innovation and regulatory science
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.569
H-Index - 44
eISSN - 2168-4804
pISSN - 2168-4790
DOI - 10.1007/s43441-020-00129-z
Subject(s) - documentation , pharmacy , warning system , misconduct , business , compliance (psychology) , enforcement , pharmaceutical industry , medicine , accounting , operations management , public relations , psychology , family medicine , computer science , engineering , pharmacology , political science , law , social psychology , programming language , telecommunications
Warning Letters issued by the Food and Drug Administration's Bioresearch Monitoring (BIMO) Program provide insight into data integrity issues and other research misconduct in the premarket side of the pharmaceutical industry. The objectives of this study were to understand the common compliance issues for clinical investigators, institutional review boards, sponsors of clinical studies, good laboratory practice laboratories, and bioequivalence studies and to see how compliance has changed over time.