There is currently a major effort to promote drug discovery in academia as a way to seed new drug development in the pharmaceutical industry. However, there are concerns in industry about the quality of drug candidates generated in academic institutions. These concerns encompass culture and perceptions with respect to intellectual property management, the process of product development, and the reliability of scientific data. Questions about data reliability underscore the particularly serious problem of mistrust in academic research. Therefore, the author became interested in the topic of industry standards for quality assurance (QA) and arranged training workshops at Okayama University on the appropriate methods for recording experimental notes by lecturers involved in QA. The outcomes are presented here.
Keywords: attributable, legible, contemporaneous, original, and accurate (ALCOA) and complete, consistent, enduring, and available (CCEA) standards; data integrity; good practice standard; laboratory notebook; research record.