1. Welch RW, Antoine JM, Berta JL, Bub A, de Vries J, Guraner F et al. Guidelines for the design, conduct and reporting of human interventions studies to evaluate the health benefits of foods. Br J Nutr 2011; 106: S4–S15.
2. ICH. Guideline for Good Clinical Practice E6(R1) 1996:
http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6_R1/Step4/E6_R1__Guideline.pdf
.
3. U.S. Department of Health and Human Services Food and Drug Administration. Guidance for industry. Oversight of clinical investigations—a risk-based approach to monitoring 2011:
www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM269919.pdf
.
4. European Medicines Agency. Reflection paper on risk based quality management in clinical trials 2011:
www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/08/WC500110059.pdf
.
5. Medicines and Healthcare Products Regulatory Agency. Risk-adapted approaches to the management of clinical trials of investigational medicinal products 2011:
www.mhra.gov.uk/Howweregulate/Medicines/Inspectionandstandards/GoodClinicalPractice/News/CON126145
.