Download Documents

​Click here to view or download the ICH E-14 Guidance Document
Click here to view or download the Health Canada QT Guidance Document
Click here to view or download the Health Canada QA regarding QT Studies
Click here to view or download the US FDA QA regarding QT Studies
Click here to view or download EMEA QA regarding QT Studies
Click here to view or download MAPP 6020.14: FDA's Interdisciplinary Review Team for QT Studies
Click here to view or download Health Canada QT product labeling recommendations
Click here to view or download the ICH S7B Guidance Document
Click here to view or download a slide that reviews BioQT
Click here to view or download ICH E-14 Q&A
Click here to view or download ICH E-14 Q&A R1 Concept Paper
Click here to view or download ICHE-14 Q&A R1 (April 2012)
Click here to view or download ICHE-14 Q&A R1 FDA (October 2012)
Click here to view or download E14-Q&A R2 ICH (March 2014)
Click here to view or download IQ First in Man TQT Study (December 2014)
Click here to view or download Implications of IQ FIM TQTS (July 2015)
Click here to view or download ICH E_14 Q&A R3 (December 2015)
Click here to view or download Which QT Protocol: Standard ICH E14 or C-E Modelling? (Nov 2016)

Jay W. Mason, MD

​Click here to download E14/SB Q&A June 14, 2020