Karmela Krleža-Jerić
Canadian Institutes of Health Research
17 Papers
27 Citations
Karmela Krleža-Jerić is an academic researcher from Canadian Institutes of Health Research. The author has contributed to research in topics: Clinical trial & Medicine. The author has an hindex of 10, co-authored 17 publications. Previous affiliations of Karmela Krleža-Jerić include University of Ottawa & University of Split.
Chat about Author
Papers
SPIRIT 2013 statement: defining standard protocol items for clinical trials.
An-Wen Chan,Jennifer Tetzlaff,Douglas G. Altman test,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 test,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
- 01 Jan 2017
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.
3.9K
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.
The use of electronic data capture tools in clinical trials: Web-survey of 259 Canadian trials
TL;DR: The adoption of EDC systems in clinical trials in Canada is higher than the literature indicated: a large proportion of clinical Trials in Canada use some form of automated data capture system.
110
Reporting of Methodologic Information on Trial Registries for Quality Assessment: A Study of Trial Records Retrieved from the WHO Search Portal
Ludovic Reveiz,An-Wen Chan,Karmela Krleža-Jerić,Carlos E Granados,Mariona Pinart,Itziar Etxeandia,Diego Rada,Monserrat Martinez,Xavier Bonfill,Andrés F. Cardona +9 more
TL;DR: In order to permit adequate critical appraisal of trial results reported in journals and registries, trial registries should consider requesting details on key RCT methods to complement journal publications.