ROTEIRO PARA ELABORAÇÃO DE RELATÓRIO 
DE SUSPENSÃO DE ESTUDOS CLÍNICOS UNICÊNTRICOS E 
MULTICÊNTRICOS 

DADOS DO PROJETO 

1. Registro CONEP: 
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2. Título do projeto: 
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3. Razões da suspensão: 

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4. Análise do CEP sobre as razões da suspensão: 
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DADOS DOS SUJEITOS 

1. Total de sujeitos recrutados no centro/ em cada centro: 
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2. Total de sujeitos incluídos no centro/ em cada centro: 
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3. Total de sujeitos selecionados para randomização centro/ em cada centro: 
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4. Total de sujeitos excluídos na randomização centro/ em cada centro: 
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5. Total de sujeitos efetivamente incluídos no estudo (após a randomização) centro/ 
em cada centro: 
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6. Total de sujeitos retirados/descontinuados centro/ em cada centro: 
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7. Todos os centros participantes suspenderam o estudo? Se não, justifique. 
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8. Houve registro de eventos adversos graves por parte dos pesquisadores em 
algum centro participante? 
· Se sim, em qual(is) centro(s)? 
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· Qual(is) foi(ram) o(s) eventos adversos? 
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· Qual a conduta tomada? 
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9. Algum sujeito buscou compensação por danos causados por este estudo em 
algum dos centros participantes? 
· Se sim, em qual (is) centro(s)? 
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· Qual (is) foi (ram) o (os) dano(s)? 
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· Qual a conduta tomada? 
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DADOS DA SEGURANÇA DOS SUJEITOS MEDIANTE SUSPENSÃO DO 
ESTUDO 

1. Informar como foi feito o acompanhamento dos sujeitos de pesquisa (mencionar 
quais as medidas de proteção tomadas em relação aos sujeitos que foram 
realizadas). 
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