Clinical Trials Register Platform

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

• Executive Comittee Meetings: Fiocruz Oct. 2009, Fiocruz Nov. 2009, BIREME Dec. 2009, Elluminate Jan. 2010, BIREME Jan. 2010, Fiocruz Fev. 2010, Online Mar. 2010?,

• Consultative Comittee Meetings: BIREME Jan. 2010, Fiocruz Fev. 2010

Technical documents

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

• WebPlatform: analysis and selection of tools for this project

• HowToInstall: instructions for deployment

• CodingStandards: best practices and procedures for developers

About this project

• SobreEsteProjeto (in Portuguese)

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