K
Karmela Krleža-Jerić
Researcher at Canadian Institutes of Health Research
Publications - 17
Citations - 7968
Karmela Krleža-Jerić is an academic researcher from Canadian Institutes of Health Research. The author has contributed to research in topics: Clinical trial & Public disclosure. The author has an hindex of 10, co-authored 17 publications receiving 5732 citations. Previous affiliations of Karmela Krleža-Jerić include University of Ottawa & University of Split.
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SPIRIT 2013 statement: defining standard protocol items for clinical trials.
An-Wen Chan,Jennifer Tetzlaff,Douglas G. Altman,Andreas Laupacis,Peter C Gøtzsche,Karmela Krleža-Jerić,Asbjørn Hróbjartsson,Howard Mann,Kay Dickersin,Jesse A. Berlin,Caroline J Doré,Wendy R. Parulekar,William S.M. Summerskill,Trish Groves,Kenneth F. Schulz,Harold C. Sox,Frank W. Rockhold,Drummond Rennie,David Moher +18 more
TL;DR: The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol, is presented in this paper.
SPIRIT 2013 statement: Defining standard protocol items for clinical trials
An-Wen Chan,Jennifer Tetzlaff,Douglas G. Altman,Andreas Laupacis,Peter C Gøtzsche,Karmela Krleža-Jerić,Asbjørn Hróbjartsson,Howard Mann,Kay Dickersin,Jesse A. Berlin,Caroline J Doré,Wendy R. Parulekar,Summerskill Wsm.,Trish Groves,K F Schulz,Harold Sox,Frank W. Rockhold,M Rennie,David Moher +18 more
TL;DR: The systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 is described, a guideline for the minimum content of a clinical trial protocol.
Journal ArticleDOI
Spirit 2013 statement: Defining standard protocol items for clinical trials
An-Wen Chan,Jennifer Tetzlaff,Douglas G. Altman,Andreas Laupacis,Peter C Gøtzsche,Karmela Krleža-Jerić,Asbjørn Hróbjartsson,Howard Mann,Kay Dickersin,Jesse A. Berlin,Caroline J Doré,Wendy R. Parulekar,William S.M. Summerskill,Trish Groves,Kenneth F. Schulz,Harold C. Sox,Frank W. Rockhold,Drummond Rennie,David Moher +18 more
TL;DR: The systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 is described, a guideline for the minimum content of a clinical trial protocol.
Journal ArticleDOI
Principles for international registration of protocol information and results from human trials of health related interventions: Ottawa statement (part 1)
TL;DR: An open meeting on 4 October 2004 in Ottawa, Canada, to foster international consensus on trial registration aims to establish internationally recognised principles for registration and highlights and discusses some of the key principles.
Journal ArticleDOI
Sharing and reuse of individual participant data from clinical trials: principles and recommendations
Christian Ohmann,Rita Banzi,Steve Canham,Serena Battaglia,Mihaela Matei,Christopher Ariyo,Lauren B. Becnel,Barbara E. Bierer,Sarion R. Bowers,Luca Clivio,Monica Dias,Christiane Druml,Hélène Faure,Martin Fenner,Jose Galvez,Davina Ghersi,Christian Gluud,Trish Groves,Paul Houston,Ghassan Karam,Dipak Kalra,Rachel L Knowles,Karmela Krleža-Jerić,Christine Kubiak,Wolfgang Kuchinke,Rebecca Kush,Ari Lukkarinen,Pedro Silverio Marques,Andrew Newbigging,Jennifer O’Callaghan,Philippe Ravaud,Irene Schlünder,Daniel Shanahan,Helmut Sitter,Dylan Spalding,Catrin Tudur-Smith,Peter van Reusel,Evert-Ben van Veen,Gerben Rienk Visser,Julia Wilson,Jacques Demotes-Mainard +40 more
TL;DR: The adoption of the recommendations in this document would help to promote and support data sharing and reuse among researchers, adequately inform trial participants and protect their rights, and provide effective and efficient systems for preparing, storing and accessing data.