.................................................................................................................................................................... 4 Research questions .............................................................................................................................................. 5 Introduction ............................................................................................................................................................ 6 Problem statement ............................................................................................................................................... 7 Scope of GRiP deliverable 3.01 ........................................................................................................................ 7 Methods .................................................................................................................................................................... 8 PHASE I: Regulatory and Scientific Guidance ......................................................................................................... 8 PHASE II: Empirical Evidence Gathering .................................................................................................................. 8 PHASE III: Tool Development ........................................................................................................................................ 9 Deliverables .......................................................................................................................................................... 10 Methods 31 December 2014 ..................................................................................................................................... 10 Final GRiP deliverable, to be finished by 30 September 2015 ....................................................................... 10 Knowledge Translation, to be finished by 31 December 2015 ...................................................................... 10 Appendix 1: Glossary of terms .................................................................................................................................... 11 Appendix 2: Adapted AGREE II Statement for Non-clinical Guidance ........................................................ 13 References ........................................................................................................................................................... 14 Document History ............................................................................................................................................. 15 GRiP – Global Research in Paediatrics D3.6 Evidenceand consensus-based guidance for the design, conduct and reporting of paediatric CTs (2) 3 List of authors Name Institution Activities Martin Offringa: martin.offringa@sickkids.ca Sick Kids W, C, R Mufiza Kapadia: mufiza.kapadia@sickkids.ca Sick Kids W, C, R Winnie Chan: winnie.chan@sickkids.ca Sick Kids W, C, R Pravheen Thurairajah: pravheen.thurairajah@sickkids.ca Sick Kids W