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2020, Number 2

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Revista Cubana de Informática Médica 2020; 12 (2)

Library for designing the case report form of clinical trials in Openclinica

Sánchez PV, Rey KDM, Ramos MG, Veliz AY, Alvarez FY, Barrera MM

Language: Spanish
References: 10
Page:
PDF size: 538.05 Kb.


ABSTRACT

Introduction: CENCEC uses OpenClinica software to design the database of the Case Report Forms (CRF) of the clinical trials (CT). Every trial has specific characteristics although some of them are common to all trials which permit to standardize the process.
Objective: To develop a library of templates in order to design the CRF.
Methods: A documentary analyses of the standards for data management in clinical trials was performed and in addition of that four designs developed at OpenClinica were reviewed.
Results: A library of 14 templates according to data types of CT was proposed. Every template is an Excel file with five sheets in which the definitions of the CRF is registered. The templates have been used in three CT.
Conclusions: The 14 templates that make up the CRF library were designed allowing their future reuse in the management of data from new clinical trials.


REFERENCES

  1. International Conference Harmonisation. Normas De Buena Práctica Clínica. Guía Armonizada de ICH Anexo Integrado a ICH E6 (R1): Guía Para La Buena Práctica Clínica ICH E6 (R2) Pauta De Consenso De ICH [Internet]. [citado 25 Oct 2019]. Disponible en: https://ichgcp.net/es/1-glossary/.

  2. CRD electrónico [Internet]. [citado 9 Mar 2020]. Disponible en: https://www.sharecrf.com/es/caracteristicas/crd-electronico.

  3. Gaddale J. R. Clinical Data Acquisition Standards Harmonization importance and benefits in clinical data management. Perspect Clin Res [Internet]. [cited 2020 Aug 11];6 (4):179–83. Available from: doi: 10.4103/2229-3485.167101.

  4. Clinical Data Interchange Standards Consortium Web site. To Amplify Data's Impact, CDISC Collaborative Standards Forum (CSF) [Internet]. 2002 [cited 2019 Nov 5]. Available from: http://www.cdisc.org/about/.

  5. Ruberg S. No one is as smart as everyone: CDISC and the Collaborative Standards Forum. DIA eBusiness Conference [Internet]. [cited 2019 Nov 5]. Available from: http://www.cdisc.org/publications/past_presentations.html.

  6. OpenClinica Enterprise Web site. OpenClinica press release. Hundreds of standardized CRFs now available in the OpenClinica Enterprise Case Report Form Library [Internet]. [cited 2019 Nov 5]. Available from: http://www.openclinica.org/crflibrary/.

  7. Medical University of South Carolina Web Site. Data Coordination Unit Case Report Form Library [Internet]. [cited 2019 Nov 5]. Available from: https://dcu.musc.edu/tools/crf_lib.asp.

  8. Openclinica [Internet]. [cited 2019 Nov 17]. Available from: https://www.openclinica.com/?lang=es.

  9. Openclinica Reference Guide. Create and Modify Case Report Forms (CRFs) [Internet]. [cited 2019 Nov 17]. Available from: https://docs.openclinica.com/3.1/study-setup/build-study/create-case-report-forms-crfs#content-title-5230.

  10. Clinical Data Acquisition Standards Harmonization CDASH 2.0 [Internet]. [cited 2020 Feb12]. Available from: https://www.cdisc.org/standards/foundational/cdash.




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