W1 AM Nuts and Bolts of Logistics and Data Management for Data-Intensive Programs
Wednesday, 16 November 2005: 8:00 AM - 11:40 AM in Ballroom 1

(KEN-1117-552158) Data Quality Assessment: A Critical – But Inadequately Applied – Component of HPV Chemical Regulation.

Kent, D¹, Heinze, J², ¹ Compliance Services International, Arlington, VA, USA² Council for LAB/LAS Environmental Research (CLER), Washington, DC, USA

ABSTRACT- The HPV Challenge, ICCA HPV Initiative, OECD SIDS, and other data collection programs (both voluntary and mandatory) all rely on the compilation of existing data. These data may come from high quality laboratory study reports or from older studies conducted before GLP standards and inadequately reported in journals or in conference presentations where the ability to assess data quality is limited. The reliability of existing data directly affects both the need to conduct additional testing and the values (toxicity, persistence, etc.) that will be used to make regulatory decisions. Therefore it is critical that data compilers and reviewers adequately assess the quality of the data for regulatory uses. This presentation will discuss some of the hidden reasons why data quality may be impacted, and how to determine what quality level can appropriately be assigned. The presentation will also introduce a strategy for adequately assessing data quality for the HPV program and other regulatory uses. The strategy recognizes the two main components of data quality: quality of the study conduct, and quality and completeness of the reporting and communication process. The use of original study reports rather than later review articles is stressed, as is the proper use of a data quality classification criteria standard. Finally, guidance will be presented on how to prepare a proper robust summary so that a user can fully understand what was tested, how it was tested, and how to interpret the results.

Key words: HPV, data, quality, chemical