1. ICH E6 (R2), EMA/CHMP / ICH / 135/1995: Guideline for good clinical practice, 30–31. (2017). https://www.ema.europa.eu/en/documents/scientific-guideline/ich-e-6-r2-guideline-good-clinical-practice-step-5_en.pdf
2. Vaught JB, Henderson MK. (2011). Biological sample collection, processing, storage and information management. IARC Sci Publ. 163:23–42. https://pdfs.semanticscholar.org/32ed/d15bca381c4deb4d71079c2c857ea34e6473.pdf
3. EMA/INS/GMP/79766/2011 Quality risk management (ICH Q9). (2011)
4. Guidelines for failure modes and effects analysis (FMEA) for medical devices. (2003). Ontario, Canada. Dyadem Press.
5. McDermott RE, Mikulak RJ, Beauregard MR. (1996). The basics of FMEA.