OpenTrials: an Open Source, multi-lingual Clinical Trials Registry Platform

Introductions

• About OpenTrials (English)

• Sobre o OpenTrials (em português)

• Presentation: PAHO Apr. 2010

Events

• Conference Call with ICTRP and Medicines Control Authority of Zimbabwe

Requirements and specification documents

• DomainReferences: background material for the Clinical Trials application domain

• TrialRegistrationDataSet (TRDS) [ES|PT-BR]: minimum required information for a registered clinical trial
  • Administrative Fields: 1 2 3 4 5 6 7 8 9 10 11
  • Scientific Fields: 12 13 14 15 16 17 18 19 20

• ControlledVocabularies: sources of terms used to describe values in some TRDS fields.

• UserStories: high-level system requirements
  • FiocruzStories, BiremeOpasStories, DecitMsStories, AnvisaStories

• UserRoles: profiles of users of a CTRP instance

• PublishingWorkflow: life cycle of a trial record

• BestPractices: standards agreed or under discussion by the ICRTP Best Practices Group

• SearchCriteria: criteria for filtering trial records in the advanced search interface

• WorkBreakdown: main modules of the system

• OpenQuestions: answers needed

Technical documents

• RegistrationDataModel: mapping of the TRDS to XML elements and RDB entities.

• WebPlatform: analysis and selection of tools for this project

• CodingStandards: best practices and procedures for developers

• ReleaseNamePolicy: understanding tags names

• Development mailing list: http://listas.bireme.br/pipermail/opentrials-dev/

• Django-Fossil no OpenTrials (em português): documentação narrativa sobre o uso do Django-Fossil

• Visão arquitetural do OpenTrials (em português)

How-Tos

• HowToInstall: instructions for deployment

• HowToTranslate: Translations policy and best practices

• DownloadAsXml: How to download in XML format

• HowToIndex: How to add new search criteria

• ComoAtualizar: Como migrar a aplicação em produção para uma versão mais nova (in Portuguese)

ReBEC: EnsaiosClinicos.gov.br

ReBEC (Resgistro Brasileiro de Ensaios Clínicos) http://www.EnsaiosClinicos.gov.br is the first instance of the OpenTrials platform. It is being developed by BIREME/PAHO/WHO with the collaboration of Fiocruz and Ministério da Saúde. It is managed by Fiocruz, with the goal of becoming an ICTRP/WHO primary registry. Most of the documents linked here are in Portuguese.

• Executive Comittee Meetings:
  • 2009: Fiocruz Oct. 2009, Fiocruz Nov. 2009, BIREME Dec. 2009
  • 2010: Elluminate Jan. 2010, BIREME Jan. 2010, Fiocruz Fev. 2010, Elluminate Mar. 2010, Elluminate Apr. 2010, Fiocruz Maio 2010, Elluminate Jun. 2010, Elluminate Jul. 2010, BIREME Jul. 2010, Elluminate Ago. 2010, BIREME Out. 2010
  • 2011: BIREME Feb. 2011, Elluminate Feb. 10 2011, Elluminate Feb. 22 2011, Elluminate Feb. 25 2011, Elluminate Mar. 01 2011, Elluminate Mar. 22 2011, Elluminate Mar. 29 2011, Elluminate Abr. 05 2011, Elluminate Abr. 19 2011, Elluminate Mai. 17 2011, Elluminate Mai. 31 2011, Elluminate Jun. 07 2011, Elluminate Aug. 02 2011, Elluminate Aug. 11 2011, Elluminate Aug. 18 2011, Elluminate Aug. 25 2011, Elluminate Sep. 01 2011

• Operations Team Meetings:
  • Elluminate Oct. 10 2011, Elluminate Nov. 25 2011, Elluminate Dec. 1 2011, Elluminate Dec. 15 2011, BIREME Jan. 19 2012

• Advisory Comittee Meetings: BIREME Jan. 2010, Fiocruz Fev. 2010, Bireme July, 2010, Fiocruz, Mar, 2011, Brasilia, Abr. 16, 2012

• Workshops
  • 2010: BIREME 26 Nov. 2010

• ReBEC project management mailing list: http://listas.bireme.br/pipermail/rebrac/

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