1. Food and Drug Administration (2011) 21 CFR part 312, subpart D: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=312&showFR=1&subpartNode=21:5.0.1.1.3.4 . and 21 CFR part 812, subpart C: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=812&showFR=1&subpartNode=21:8.0.1.1.9.3
2. The International Conference on Harmonisation (1996) Guideline for good clinical practice: E6: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdf
3. Food and Drug Administration (1988) Guidance for industry: guideline for the monitoring of clinical investigations: http://www.ahc.umn.edu/img/assets/19826/Clinical%20monitoring.pdf
4. Funning S, Grahnén A, Eriksson K, Kettis-Linblad Å (2009) Quality assurance within the scope of Good Clinical Practice (GCP)—what is the cost of GCP-related activities? A survey within the Swedish Association of the Pharmaceutical Industry (LIF)’s members. Qual Assur J 12(1):3–7
5. Scannell JW, Blanckley A, Boldon H, Warrington B (2012) Diagnosing the decline in pharmaceutical R&D efficiency. Nat Rev Drug Discov 11(3):191–200. doi: 10.1038/nrd3681