Table 2.

Clinical Development Audit Checklist¹

Business Development Plan	Organizational chart High-level business strategy with first intended use Defined working relationship between the academic and business laboratories Intellectual property status: patents, copyrights, trade secrets
Regulatory Strategy	Strategy supporting business plan/ commercialization strategy Plan for bringing components into regulatory compliance: Records, documents, change control Patient sample regulations with patient confidentiality, Informed Consent
GLP Compliance	Laboratory equipment list Document controls SOP list Laboratory notebook system Equipment controls with documentation Instrument status, calibration, maintenance and monitoring Computer systems Back-up systems, freezer alarm, environmental monitoring systems Material management: reagent stability testing, preparation, expiration dates Samples: stability chain of custody documentation, security. Supplier Controls Training: plan and records for training, certifications Assay procedures Hardware and software development strategy, life cycle
Assay System	High level technical description of assay Pre-analytic sample processing Analytic parameters: sensitivity, specificity/accuracy, precision, reproducibility, reportable range, robustness, repeatability, etc. Post-analytic parameters: data analysis/statistical analysis, reference standards, quality assurance, result reporting, reference intervals Assay components Critical reagents, components, instruments, computer systems Back-up strategy,system redundancy as appropriate
Analytical Validation	Validation plan Validation report Sample handling, assay procedure, data acquisition Instrument: data acquisition, analysis, reporting software, computer systems Reagent and sample stability studies Additional validation records from external sources

¹Abbreviations: GLP, Good Laboratory Practice; SOP, Standard Operating Procedure. Adapted from (2, 32, 38, 39).