Mason Cardiac Safety Consulting
Regulatory guidance documents, Q&A documents, and technical white papers relevant to cardiac safety and QT studies. Click any document title to open it.
ICH E-14 Guidance Document
ICH S7B Guidance Document
ICH E-14 Q&A
ICH E-14 Q&A R1 Concept Paper
ICH E-14 Q&A R1 (April 2012)
ICH E-14 Q&A R1 FDA (October 2012)
E14-Q&A R2 ICH (March 2014)
ICH E-14 Q&A R3 (December 2015)
E14/S7B Q&A (June 14, 2020)
Health Canada QT Guidance Document
Health Canada Q&A regarding QT Studies
Health Canada QT Product Labeling Recommendations
US FDA Q&A regarding QT Studies
MAPP 6020.14: FDA's Interdisciplinary Review Team for QT Studies
IRTs Highlights of Clinical Pharmacology and Cardiac Safety
QT Evaluation Report Submission Checklist
CiPA Protocol with Best Practice
EMEA Q&A regarding QT Studies
BioQT Review Slide
IQ First in Man TQT Study (December 2014)
Implications of IQ FIM TQTS (July 2015)
Which QT Protocol: Standard ICH E14 or C-E Modelling? (Nov 2016)
Technical Specifications for TQTS Submission
AF Cardioversion White Paper
Garnett 2018 C-E Modeling White Paper
CV — Jay W. Mason, MD (May 2026)
Baseline Triplicates
ECG Normal Values
QRS Rate Dependence
ECG Interpretation Algorithms
Moxifloxacin Heart Rate Effect
Automated HR Correction