7.6: References

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DAMOCLES Study Group. NHS. Health Technology Assessment Programme. 2005. A proposed charter for clinical trial data monitoring committees: helping them to do their job well. Lancet, 365, 711–22.

International Conference On Harmonisation. 1996. Technical requirements for registration of pharmaceuticals for human use: guideline for good clinical practice E6(R1) [Online]. Available at: <http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdf>.

International Conference On Harmonisation. 1998. Statistical principles for clinical trials [Online]. Available at: <http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E9/Step4/E9_Guideline.pdf>.

World Health Organization. 2005. Operational guidelines for the establishment and functioning of data and safety monitoring boards. Available at: <http://whqlibdoc.who.int/hq/2005/TDR_GEN_Guidelines_05.1_eng.pdf>.

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