Submission process of clinical research studies

Dear investigator, in order to submit a research study, follow the steps of this form.
If you have any questions, please send an email to investigacao.learninghealth@luzsaude.pt

If the study takes place in more than one unit, you should make one submission per unit.

Learning Health (LH) is responsible for Research within the Luz Saúde Group, and as such can provide support throughout the entire process of a research project. Should the Investigator or Sponsor require such support, they should contact LH through the email investigacao.learninghealth@luzsaude.pt   

Before you start the submission process, make sure that you have the following documents ready (some of the documents have templates available at Luz Link/Intranet in "documents and templates" or at Research_Documents_Sharefile).
  • Study protocol (optional example available - "Exemplo de Modelo de Protocolo de estudo")
  • Authorization from the Department Director/Declaration of Site Conditions (optional template available - "Autorização da Direção do Serviço")
  • Authorization Request to the Board of Directors and Ethics Committee (except clinical trials - optional template available - "Pedido de autorização ao Conselho de Administração e Comissão de Ética")
  • Brief CV of the Principal Investigator at the Luz Saúde unit (optional template available - "CV Investigador")
  • List of data to be collected in the scope of the study or CRF (Case Report Form)
  • Data Extraction Sheet (if applicable, usually for retrospective studies, only if our IT are asked to extract clinical data from the electronic medical system - mandatory template available - "Folha de extração de dados retrospetivos")
  • Informed consent (if applicable - 1 model of information to the participant about the study - "Folha de extração de dados retrospetivos" + 3 optional available consent models: Informed consent for study participation -  "Consentimento Informado para participação estudo"; Informed Consent for participation of an adult WITH DISABILITY - ".... maior COM INCAPACIDADE..." ; Informed Consent for participation of MINORS - "...MENORES...")
  • Draft of the Financial agreement (if applicable, only for studies with financial support - mandatory template available, please contact Learning Health for the review process)
  • Study budget (if applicable)
  • INFARMED’s authorization (if applicable)
  • CEIC’s approval (if applicable)
  •  Insurance certificate (if applicable)
  • Declaration of Consent to Data Transmission (except for clinical trials) declaration to be completed and submitted by all the members of Luz Saúde research team participating in the study. With this declaration, they commit to provide the necessary information for submission of the study to incentive programs.  The investigators also acknowledge that they are aware that the information can be shared with external entities.
  • DPIA (Data Protection Impact assessment) (If applicable, DPIA will be necessary whenever there is data treatment, either at the initial stage (by the researcher who anonymizes/pseudonymizes the data and delivers them already anonymized to the research team) or during the study.  DPIA will not be necessary if the data reaches the research team already anonymized, meaning, if the information to be used in the study was initially collected anonymously or automatically anonymized by a team outside the research team).

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