Related Experiment Video
Updated: Jul 13, 2026

Biobank for Translational Medicine: Standard Operating Procedures for Optimal Sample Management
Published on: November 30, 2022
Procedural elements involved in maintaining bioanalytical data integrity for good laboratory practices studies and
Christopher A James1, Howard M Hill
1Pharmacokinetics and Drug Metabolism, Amgen Inc, Thousand Oaks, CA 91320-1799, USA. cajames@amgen.com
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.
Related Concept Videos
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast, controlled...
Data Validation
Key parameters for method validation include:
Data Validation
Nursing assessment guides are generally based on holistic models rather than medical...
Quality Control
Quality control helps track data, visualize trends, and identify variations, making it easier to detect deviations that may affect the accuracy of an analysis. One way to do this is by generating a quality control chart, which...
Good Manufacturing Practices
Key Techniques in Microbiology

