scholarly journals A multi-technique approach to bridge electronic case report form design and data standard adoption

2015 ◽  
Vol 53 ◽  
pp. 49-57 ◽  
Author(s):  
Ching-Heng Lin ◽  
Nai-Yuan Wu ◽  
Der-Ming Liou
2012 ◽  
Vol 12 (12) ◽  
pp. 714-720
Author(s):  
Young-Hwa Baek ◽  
Ho-Seok Kim ◽  
Si-Woo Lee ◽  
Hee-Jeong Jin

2019 ◽  
Vol 22 ◽  
pp. S113
Author(s):  
M. Labrador ◽  
A. Seshatri ◽  
D. Garofalo ◽  
J. Webster ◽  
M. Gopalkrishna ◽  
...  

2019 ◽  
Vol 6 (2) ◽  
pp. 41-41
Author(s):  
Virginia Abello Polo ◽  
María Helena Solano ◽  
Iván Perdomo ◽  
Kenny Galves ◽  
José Domingo Saavedra ◽  
...  

Introducción: la ACHO está comprometida con la creación de un grupo de investigación que se encargue de desarrollar un análisis del patrón epidemiológico de los principales tipos de neoplasias hematológicas en el país. La primera neoplasia que será analizada es el mieloma múltiple (MM); este es el primer reporte preliminar de los hallazgos de este registro, que incluye información de 10 centros con investigadores de la ACHO y cuyo objetivo principal es describir el perfil epidemiológico del MM en la población colombiana y su relación con factores de mal pronóstico. Métodos: se propone un estudio descriptivo observacional multicéntrico bidireccional (retrospectivo hasta máximo 10 años y prospectivo) de 100 casos de MM en Colombia. Se recolectarán datos sociodemográficos, criterios diagnósticos de las patologías, factores pronósticos e intervenciones terapéuticas. Los datos han sido recopilados usando un Electronic Case Report Form (eCRF), compuesto de pestañas de información de acuerdo con las variables de interés del estudio. Todos los pacientes objeto de reclutamiento y aptos para ser incluidos deberán contar con consentimiento informado firmado antes del ingreso al registro epidemiológico. Resultados: los datos del registro están en recolección, los resultados estarán disponibles en la fecha final. Conclusión: los datos del registro están en recolección, los resultados estarán disponibles en la fecha final.


2011 ◽  
Vol 47 ◽  
pp. S216
Author(s):  
K.N.M. Knud Mejer ◽  
T.G. Torben Gøth ◽  
G.D. Gedske Daugaard ◽  
B.C. Birgitte Christiansen ◽  
D.N. Dorte Nielsen

F1000Research ◽  
2020 ◽  
Vol 9 ◽  
pp. 81
Author(s):  
Sander de Ridder ◽  
Jeroen A.M. Beliën

Semantic interoperability of clinical data is essential to preserve its meaning and intent when the data is exchanged, re-used or integrated with other data. Achieving semantic operability requires the use of a communication standard, such as HL7, as well as (functional) information standards. Manually mapping clinical data to a medical thesaurus, such as SNOMED CT, is complicated and requires expert knowledge of both the dataset, including its context, and the thesaurus. As an alternative, the (re-)use of codebooks, data definitions which may already have been mapped to a thesaurus, can be a viable approach. We’ve developed the iCRF Generator, a Java program that can generate the core of an interoperable electronic case report form (iCRF) for several of the major electronic data capture systems (EDCs). To build their CRFs, users can select one or more items from established codebooks, available from an online system called ART-DECOR. By providing an easy to use method to create CRFs for multiple EDCs based on the same codebooks, interoperability can be more easily attained.


F1000Research ◽  
2020 ◽  
Vol 9 ◽  
pp. 81
Author(s):  
Sander de Ridder ◽  
Jeroen A.M. Beliën

Semantic interoperability of clinical data is essential to preserve its meaning and intent when the data is exchanged, re-used or integrated with other data. Achieving semantic operability requires the use of a communication standard, such as HL7, as well as (functional) information standards. Manually mapping clinical data to a medical thesaurus, such as SNOMED CT, is complicated and requires expert knowledge of both the dataset, including its context, and the thesaurus. As an alternative, the (re-)use of codebooks, data definitions which may already have been mapped to a thesaurus, can be a viable approach. We’ve developed the iCRF Generator, a Java program that can generate the core of an interoperable electronic case report form (iCRF) for several of the major electronic data capture systems (EDCs). To build their CRFs, users can select one or more items from established codebooks, available from an online system called ART-DECOR. By providing an easy to use method to create CRFs for multiple EDCs based on the same codebooks, interoperability can be more easily attained.


2010 ◽  
Vol 39 ◽  
pp. 19-24 ◽  
Author(s):  
Ling Li Fu ◽  
Tao Chen

With more clinical trials using electronic way, new drugs electronic application has becoming an inevitable trend in near future. A well-designed case report form (CRF) is the premise of high quality clinical trials which facilitates data collection and entry, and directly benefits other facets of clinical data management. Firstly, paper introduces the CRF design modes and design principles. Then paper describes the CRF design process, and based on this, paper constructs the data structure with CDISC ODM concept. Lastly, paper explores how to convert the paper CRF to electronic format in web application with SAS statistic requirements in detail.


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