Here is a case where the title belies the full scope of the guidance. In the Introduction, FDA states:
"The purpose of this guidance is to provide recommendations to applicants and testing site management on achieving and maintaining data integrity for the clinical and bioanalytical portions of bioavailability (BA) and bioequivalence (BE) studies submitted in support of investigational new drug applications (INDs), new drug applications (NDAs), and abbreviated new drug applications (ANDAs), and the bioanalytical portion of clinical pharmacologic studies supporting CDER-regulated biologic license applications (BLAs) as well as amendments and supplements to these applications. In addition, the recommendations in this guidance apply to the bioanalytical portion of nonclinical studies. FDA also encourages applicants and testing sites to consider these recommendations when conducting other studies, including in vitro and pharmacology and toxicology studies."
The bolded statements put most of what regulated bioanalytical labs do within the scope of this guidance. Prior to getting into the details, the guidances notes the difference between data integrity and data quality:
"data integrity refers to the accuracy, completeness, and reliability of data" (i.e., the ALCOA+ principles)
"data quality refers to the assurance that data produced are generated in compliance with applicable standards and can be used for its intended purpose"
It also indicates the applicability to both electronic and other forms of records.
Once into the details, they are extensive and broad covering all aspects of clinical trial conduct with the associated participants and systems.
#fda #DataIntegrity #BE #BA
link to guidance
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Mark Arnold Ph.D., FAAPS
Westampton, NJ
[email protected]Bioanalytical Solution Integration
LinkedIn:
https://www.linkedin.com/in/markearnoldphd/Website & Blog: Bioanalysis & Biomarkers <bioanalysisandbiomarkers.blogspot.com>
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