title: Procedural elements involved in maintaining bioanalytical data integrity for good laboratory practices studies and regulated clinical studies.
abstract: This article describes procedural elements involved in ensuring the integrity of bioanalytical data. These elements can be divided into 3 areas. First, there are those ensuring the integrity of the analyte until analysis, through correct sample collection, handling, shipment, and storage procedures. Incorrect procedures can lead to loss of analyte via instability, addition of analyte through contamination or instability of related metabolites, or changes in the matrix composition that may adversely affect the performance of the analytical method. Second, the integrity of the sample identity needs to be maintained to ensure that the final result reported relates to the individual sample that was taken. Possible sources of error include sample mixup or mislabeling, or errors in data handling. Finally, there is the overall integrity of the documentation that supports the analysis, and any prestudy validation of the method. This includes a wide range of information, from paper and electronic raw data, through standard operating procedures and analytical procedures and facility records, to study plans and final reports. These are critical to allow an auditor or regulatory body to reconstruct the study.
authors.affiliation: Pharmacokinetics and Drug Metabolism, Amgen Inc, Thousand Oaks, CA 91320-1799, USA. cajames@amgen.com
authors.forename: Christopher A
authors.initials: CA
authors.lastname: James
authors.forename: Howard M
authors.initials: HM
authors.lastname: Hill
mesh_terms: D002623:Chemistry Techniques, Analytical / Q000592:standards*; D019411:Clinical Laboratory Techniques / Q000592:standards*; D002986:Clinical Trials as Topic / Q000592:standards*; D006801:Humans; D011786:Quality Control; D015203:Reproducibility of Results; D013048:Specimen Handling / Q000592:standards*