Estudos Pré-Clínicos
PESQUISADOR COMISSÃO COMITÊ/
Cadastro Online da Pesquisa (se houver) Protocolo (Integral e em Português)
Termo de Consentimento Livre e Esclarecido (TCLE) conforme modelo institucional se houver)
Folha de Rosto
Aspectos financeiros do Estudo Clínico (orçamento detalhado) Aprovação no país de origem
Lista de Centros participantes (indicação do 1º Centro) Comprovante de Pagamento da taxa de submissão Carta de Submissão
Brochura do Investigador Emendas (se houver)
Documentos informativos (se houver) Publicidade para recrutamento (se houver) Declaração de seguro
Curriculum vitae (Conforme solicitado pela instituição) Valores normais/ variações para procedimentos e/ou exames médicos, laboratoriais/ técnicos incluídos no protocolo Procedimentos, exames médicos, laboratoriais e técnicos (certificado ou, credenciamento, ou controle de qualidade estabelecido e/ou avaliação externa de qualidade, ou outras validações quando necessário)
Modelo de etiqueta afixada no recipiente do produto em investigação (se houver)
Instruções para o manuseio do produto em investigação e do material relacionado ao estudo (se não incluído no protocolo ou brochura do investigador)
Registro de embarque para produtos sob investigação e materiais relacionados ao estudo
Certificado de análise do produto sob investigação enviado Procedimentos para decodificação de estudos cegos (se houver)
Relação geral de randomização
Todos os documentos solicitados pelo patrocinador, Normas de Boas Práticas Clínicas e Normatizações institucionais foram anexados a este formulário
INFORMAÇÕES ADICIONAIS (Identifique o documento faltante
e justifique)
* Preenchimento obrigatório
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