Читать книгу The Fundamentals of Clinical Research - P. Michael Dubinsky - Страница 35

1 1 EMA Scientific Guidelines http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000043.jsp&mid=WC0b01ac05800240cb (accessed 27 January 2020)

2 2 FDA (2000). Good Guidance Practices/Guidance documents FDA Regs at 21 CFR 10.115. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=10.115 (accessed 27 January 2020)

3 3 EMA (2012). Reflection paper on laboratories that test clinical trial samples http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2012/05/WC500127124.pdf (accessed 27 January 2020)

4 4 ISO (2011) ISO 14155:2011). Clinical Investigation of Medical Devices for Human Subjects — Good Clinical Practice. International Organization for Standardization https://www.iso.org/standard/45557.html (accessed 27 January 2020).

5 5 Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on Clinical Trials on Medicinal Products for Human Use, and Repealing Directive 2001/20/EC https://ec.europa.eu/health//sites/health/files/files/eudralex/vol‐1/reg_2014_536/reg_2014_536_en.pdf (accessed 27 January 2020)

6 6 Penn Medicine (2020). What is an Academic Medical Center. https://www.pennmedicine.org/about/benefits‐of‐an‐academic‐medical‐center (accessed 27 January 2020)