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2012, Number 1

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Revista Cubana de Informática Médica 2012; 4 (1)

“ALASCLÍNICAS”: Clinical trial management system

Rodríguez GL, Hernández RMD, Díaz PR, Martínez JE, Hernández CL, González EL
Full text How to cite this article

Language: Spanish
References: 13
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Key words:

administration of clinical rehearsals, clinical data, clinical rehearsals.

ABSTRACT

The Clinical Trials constitute a type of medical study that, through their application to human beings, seek to value the effectiveness and security of new medications or treatments. All the scientific centers of the country that develop new medications need the execution of Clinical Trials to determine if these will contribute to prevent, detect or treat an illness; standing out vaccines against the cancer, the AIDS and other sufferings. At the moment this process associated to the Clinical Trials, is carried out gathering all the data in paper and transmitting the information, of the hospitals to the centers promoters and vice versa, generally via electronic mail or phone. To achieve the administration of the Clinical Trials, several electronic systems in the world have been carried out, among them, the OpenClinica system, which embraces great part of the processes in the administration of the Clinical Trials in the Molecular Immunology Center in Cuba, but not the entirety of these processes. With the objective of obtaining a system that embraces all the necessary requirements, it decides to adapt OpenClinica to obtain the system of handling of clinical trials: alasClínicas like tool for the control and pursuit of all the information associated to the Clinical Trials, facilitating the handling and storage of the same one. It consists of four fundamental modules: To administer company, Negotiate study, Negotiate data and Extract data. This work is guided to present the proposal of this system, showing its significant characteristics, functionalities and its contribution to the increase of the quality of life of the Cuban society.


REFERENCES

  1. ClinicalTrials, Understanding Clinical Trials. National Institutes of Health. 2007. Disponible en http://clinicaltrials.gov/ct2/info/understand

  2. Aznar-Salatti, J. Diseño de protocolos de un estudio clínico: las denominadas "case report forms" o cuadernos de recogida de datos. Jano [revista electrónica]. 1997. Disponible en http://www.uv.es/~docmed/documed/documed/591.html

  3. CIMAher. Centro de Inmunología Molecular. 2009. Disponible en http://www.cimaher.com/index.php?action=cim

  4. Leon Monzón, K. Propuesta de proyecto de colaboración con la UCI. Departamento de Ensayos Clínicos, Centro de Inmunología Molecular. 2006.

  5. Open Clinica, Open Source for Clinical Research. Akaza Research. 2007. Disponible en http://www.openclinica.org/section.php?sid=1

  6. Rational Unified Process. 2011. Disponible en http://www.rational.com.ar/herramientas/rup.html

  7. Barr, Sherold. DataLabs Introduces Single Data Management System to Unify Paper Data Entry and Electronic Data Capture. 2005. Disponible en http://www.datalabs.com/

  8. PRA International. 2011. Disponible en http://www.prainternational.com

  9. Medidata Solutions. 2011. Disponible en http://www.mdsol.com

  10. Bayer Healthcare estandariza la solución de gestión de datos clínicos Medidata So-lutions RAVE. 2011. Disponible en http://www.prnewswire.co.uk

  11. Bayer AG. 2011. Disponible en http://www.bayer.com

  12. Kbeedocs. 2011. Disponible en http://www.kbeedocs.com

  13. Trial Médico Elipse III. 2011. Disponible en http://www.opensistemas.com/soluciones/soluciones_a_medida/




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Revista Cubana de Informática Médica. 2012;4