ETI - Ética

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Overview

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Key Features

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Ethics Committee Management

• Committee Configuration: Set up multiple ethics committees (CEI, CEEA, etc.) with specific workflows
• Evaluator Management: Assign evaluators with expertise areas and conflict of interest tracking
• Meeting Scheduling: Plan committee meetings with agendas and documentation
• Minute Management: Generate and approve formal meeting minutes (Acta)
• Dynamic Forms: Configure custom evaluation forms per committee type

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Ethics Review Process (Memorias)

• Submission Types:
  • NUEVA: New ethics review request
  • MODIFICACION: Modification to existing approval
  • RATIFICACION: Ratification of previous decision
• State Workflow: Track submission through evaluation states (TipoEstadoMemoria)
• Version Control: Maintain version history of submissions
• Retrospective Reviews: Handle retrospective ethics reviews when required
• Multi-language Support: Titles and content in multiple languages

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Evaluation Workflow

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Dynamic Forms and Reports

• Form Configuration: Use Formly-based dynamic forms for flexible data collection
• Custom Checklists: Define evaluation criteria per committee type
• Multi-language Reports: Generate reports in different languages using configured templates
• Report Types: Ethics approval certificates, evaluation reports, committee minutes

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Main Entities

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Comité (Ethics Committee)

• codigo: Committee code (e.g., “CEI”, “CEEA”)
• nombre: Committee name (multi-language)
• formularioMemoriaId: Main evaluation form
• formularioSeguimientoAnualId: Annual follow-up form
• formularioSeguimientoFinalId: Final follow-up form
• formularioRetrospectivaId: Retrospective review form
• requiereRetrospectiva: Whether committee requires retrospective reviews
• prefijoReferencia: Reference prefix for memory codes
• permitirRatificacion: Allow ratification submissions
• Configuration flags for task and memory customization

• Evaluador: Committee members and evaluators
• ConvocatoriaReunion: Committee meetings
• CargoComite: Committee positions/roles

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Memoria (Ethics Memory/Submission)

• numReferencia: Unique reference number
• peticionEvaluacion: Associated evaluation request
• comite: Ethics committee handling the review
• formulario: Evaluation form used
• titulo: Memory title (multi-language)
• personaRef: Responsible researcher
• tipo: Memory type (NUEVA, MODIFICACION, RATIFICACION)
• estadoActual: Current state in workflow
• fechaEnvioSecretaria: Submission date
• version: Version number
• requiereRetrospectiva: Retrospective review required flag
• retrospectiva: Linked retrospective review
• memoriaOriginal: Original memory for modifications

• Evaluacion: Evaluations performed on the memory
• DocumentacionMemoria: Supporting documents
• EstadoMemoria: State history
• Comentario: Comments and feedback

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PeticionEvaluacion (Evaluation Request)

• titulo: Request title
• resumen: Research summary
• objetivos: Research objectives
• disMetodologico: Methodological design
• fuenteFinanciacion: Funding source
• Team and researcher information
• Risk assessment data

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Evaluacion (Evaluation)

• memoria: Memory being evaluated
• convocatoriaReunion: Committee meeting
• tipoEvaluacion: Evaluation type
• dictamen: Final decision/verdict
• evaluador1, evaluador2: Assigned evaluators
• version: Evaluation version
• Comments and assessment data

• Comentario: Evaluation comments
• Dictamen: Possible verdicts (approved, rejected, modifications required, etc.)

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ConvocatoriaReunion (Committee Meeting)

• comite: Committee holding the meeting
• fechaEvaluacion: Meeting date and time
• lugar: Meeting location (multi-language)
• ordenDia: Agenda (multi-language)
• tipoConvocatoriaReunion: Meeting type
• horaInicio, horaInicio2: Session times
• videoconferencia: Video conference flag

• Asistentes: Meeting attendees
• DocumentacionConvocatoriaReunion: Meeting documentation
• Acta: Generated meeting minutes

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Acta (Meeting Minutes)

• convocatoriaReunion: Associated meeting
• numero: Minutes number
• resumen: Summary (multi-language)
• estadoActual: Current state
• inactiva: Inactive flag

• ActaDocumento: Formal minutes documents
• Comentario: Comments and decisions recorded

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User Workflows

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Submitting an Ethics Review Request

1. Create new evaluation request (PeticionEvaluacion)
2. Complete research details: objectives, methodology, funding
3. Define research team and responsibilities
4. Assess ethical risks and considerations
5. Create associated memory (Memoria)
6. Select appropriate committee and form
7. Complete ethics evaluation form
8. Attach required documentation
9. Submit to committee secretary
10. Track evaluation status

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Conducting Committee Review

1. Secretary receives and validates submissions
2. Assign evaluators (avoiding conflicts of interest)
3. Evaluators review and complete checklists
4. Schedule committee meeting
5. Prepare meeting agenda with memories to review
6. Distribute documentation to committee members
7. Conduct meeting and discuss each case
8. Record decisions in minutes (Acta)
9. Generate formal approval/rejection documents
10. Notify researchers of decisions
11. Track follow-up requirements

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Managing Follow-up Reports

1. Approved projects receive follow-up requirements
2. Researchers submit annual follow-up reports
3. Committee reviews compliance
4. Final follow-up report at project completion
5. Close ethics approval record

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Dynamic Form System

• Ethics memory evaluation forms
• Annual follow-up forms
• Final follow-up forms
• Retrospective review forms
• Task and training forms

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Report Generation

• FormularioReport: Links forms to report templates
• Informe: Generated report metadata
• InformeDocumento: Report documents in multiple languages

• Ethics approval certificates
• Evaluation reports
• Committee minutes
• Follow-up assessments

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Conflict of Interest Management

• Track evaluator conflicts (ConflictoInteres)
• Prevent assignment of conflicted evaluators
• Automatic validation during assignment
• Transparency in committee decisions

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Integration Points

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API Endpoints

• /comites: Committee management
• /memorias: Memory submission and tracking
• /peticion-evaluaciones: Evaluation requests
• /evaluaciones: Evaluation management
• /convocatoria-reuniones: Meeting scheduling
• /actas: Minutes management
• /evaluadores: Evaluator assignment

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Database Schema

sgi-eti-service/src/main/resources/db/changelog/

• comite - Ethics committees
• memoria - Ethics submissions
• evaluacion - Evaluations
• convocatoria_reunion - Meetings
• acta - Minutes
• formulario - Dynamic forms
• Supporting tables for form definitions and relationships

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Frontend Components

sgi-webapp/src/app/module/eti/

• Memory submission wizard
• Committee dashboard
• Evaluation interface
• Meeting management
• Dynamic form rendering
• Report generation tools