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Research projects

Types of studies IEC

Research projects

Research projects include any project that does not meet the criteria to be considered observational studies with drugs, research with healthcare products, or clinical trials with drugs. Some examples would be:

  • Study of active patient participation, such as responses to questionnaires or therapeutic interventions or the co-creation and co-design of interventions.
  • Use of data from previous studies.
  • Projects for the improvement of health management, review of protocols and action procedures.
  • Administration of nutritional supplements or adjuncts.

Documents to be provided as part of the protocol  

  • IDIAPJGol Application Form.
  • Patient Information Sheet and Informed Consent (if applicable).
  • Data Protection Impact Assessment (DPIA) (if applicable).
  • Insurance Policy (if applicable).
  • Payment of Fees or Waiver of Fees.

Mandatory sections within the protocol

  • Economic report (if applicable) (not applicable for SIDIAP projects).
  • Procedures and materials used for subject recruitment (if applicable).
  • Section on ethical considerations and data protection

  • Informed consent exemption - Compatibility principle

  • Project Protocol Form (Model 03)

  • IMP-226-Project Entry Form

  • Biological samples protocol

  • Application for fee exemption

  • Patient information sheet (model 04)

  • Informed Consent (model 05)

  • Informed Consent for Biological Samples (model 06)

  • Informed Consent Cessio Images (model 07)

Data Protection Impact Assessment (DPIA)

Board of Trustees

Collaborators

Accreditations