Version 21 (modified by luciano.ramalho, 3 years ago)

--

Field 15. Study Type

  1. Field 15. Study Type
    1. WHO description
    2. Schema
    3. Validation
    4. Labels
    5. Sample Values
    6. Discussion
      1. Fields for possible future implementation
      2. Who Primary Registry Criteria

WHO description

A single arm study is one in which all participants are given the same intervention. Trials in which participants are assigned to receive one of two or more interventions are NOT single arm studies. Crossover trials are NOT single arm studies.

A trial is "randomized" if participants are assigned to intervention groups using a method based on chance (e.g., random number table, random computer-generated sequence, minimization, adaptive randomization).

Schema

Validation

Labels

EN: Study Type

PT: Tipo de estudo

ES: Tipo de estudio

Sample Values

sample 1
sample 2
sample 3

Discussion

Programa de acesso expandido (expanded access program) (Executive Committee 2009-11-19)

  • yes
  • no

Sugestão de sub-campos para o tipo de estudo (provenientes da Plataforma Brasil - CONEP):

Enfoque principal do estudo / purpose of the study / propósito del estudio (I,O)

  • Diagnóstico (diagnostic)
  • Etiológico (etiological)
  • Prognóstico (prognostic)
  • Prevenção (prevention) prevención
  • Terapêutica / Operatória (treatment/surgery)
  • Outro: _ (other)

Tipo de destinação do estudo / Type of study endpoint / (I,O)

  • |X| Segurança (safety)
  • |X| Eficácia (efficacy)
  • |X| Bioequivalência (bioequivalence)
  • |X| Biodisponibilidade (biodisponibility)
  • |X| Farmacocinética (pharmacokinetics)
  • |X| Farmacodinâmica (pharmacodynamics)
  • |X| Farmacogenética (pharmacogenetics)

Fase do ensaio (CIOMS) / Phase / Fase (I)

  • Fase 0 (exploratória) (phase 0)
  • Fase 1 (phase 1)
  • Fase 1/2 (phase 1/2)
  • Fase 2 (phase 2)
  • Fase 2/3 (phase 2/3)
  • Fase 3 (phase 3)
  • Fase 4 (phase 4)
  • N/A (N/A) - default

Desenho da intervenção / intervention assignment / diseño de la intervención: (I)

  • Grupo único (single group)
  • Paralelo (parallel)
  • Cruzado (cross-over)
  • Fatorial (factorial)
  • Outro: (other)

Número de braços / number of arms / numero de brazos (I,O)

_ (enter 1 for single-arm study).

Tipo de mascaramento / type of masking / tipo de enmascaramiento: (I)

  • Aberto (open) abierto
  • Unicego (single blind) simple ciego
  • Duplo-cego (double-blind) doble ciego
  • Triplo-cego (triple-blind) triple ciego

Tipo de alocação / allocation type / tipo de asignación: (I)

  • Não randomizado controlado (non-randomized controlled) controlado no-aleatorizado
  • Randomizado controlado (randomized controlled) controlado aleatorizado
  • N/A (single arm study) N/A (brazo único)

Desenho do estudo observacional / observational study design [otherwise skip] / diseño de estudio observacional: (O)

  • Coorte (cohort)
  • Caso-controle (case-control)
  • Caso (case study)
  • Caso-cruzado (crossover)
  • Ecológico ou comunidade (ecologic or community studies)
  • Base familiar (family-based)
  • Outro: (other)

Fields for possible future implementation

Tipo de estudo / Study type / Tipo de estudio:

  • Intervenção (interventional) intervención (Executive Committee 2009-08-06)
  • Observacional (observational) observacional (Executive Committee 2009-08-06)

Temporalidade / time perspective / temporalidad: (O)

  • Prospectivo / Prospective
  • Retrospectivo / retrospective
  • Retrospectivo e prospectivo / restropective and prospective
  • Transversal / Cross-sectional
  • Outro / Other

Who Primary Registry Criteria

Content: "If a registry does include these studies [clinical trials registered retrospectively and/or observational studies] then it should be possible to distinguish between prospectively registered interventional trials and other studies".

(use this area to post further suggestions)

Fields suggested by WHO Best practice - Study type

  • controle / control
  • placebo / placebo/ placebo
  • ativo / active / activo
  • não-controlado / uncontrolled / non-controlado
  • histórico / historical / histórico
  • comparação de dose / dose comparison / comparación de dosis

Fields suggested by WHO Best practice - Study type & Plataforma Brasil

  • Quem está sendo mascarado / Who is masked
  • sujeito da pesquisa / participant / participante
  • colaborador profissional / profesional colaborator/ colaborador
  • investigador / investigator / investigador
  • estatístico bioestatistico analista de dados / statistician or data analystis
  • consultor
  • assessor

Part of: TrialRegistrationDataSet