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QMSQMS
QMS
  • Welcome to your QMS
  • Quality Manual
  • Procedures
    • GP-001 Control of documents
    • GP-002 Quality planning
    • GP-003 Audits
    • GP-004 Vigilance system
    • GP-005 Human Resources and Training
    • GP-006 Non-conformity, Corrective and Preventive actions
    • GP-007 Post-market surveillance
    • GP-008 Product requirements
    • GP-009 Sales
    • GP-010 Purchases and suppliers evaluation
    • GP-011 Provision of service
    • GP-012 Design, Redesign and Development
    • GP-013 Risk management
    • GP-014 Feedback and complaints
    • GP-015 Clinical evaluation
      • Templates
        • T-015-001 Clinical Evaluation Plan_YYYY_nnn
        • T-015-002 Preclinical and clinical evaluation record_YYYY_nnn
        • T-015-003 Clinical Evaluation Report_YYYY_nnn
        • T-015-004 Clinical Investigation Plan_Study code
        • T-015-005 Investigator's Brochure_Study code_es
        • T-015-006 Clinical investigation report_Study code_en
        • T-015-006 Clinical investigation report_Study code_es
        • T-015-007 Delaration of interest Clinical evaluation team
        • T-015-008 Clinical development plan_YYYY_nnn
        • T-015-009 Clinical Investigation Plan_Study code_en
    • GP-016 Traceability and identification
    • GP-017 Technical assistance service
    • GP-018 Infrastructure and facilities
    • GP-019 Software validation plan
    • GP-020 QMS Data analysis
    • GP-021 Communications
    • GP-022 Document translation
    • GP-023 Change control management
    • GP-024 Cybersecurity
    • GP-025 Corporate Governance
    • GP-026 Product requirements for US market
    • GP-027 Product requirements for UK market
    • GP-028 Product requirements for the Brazilian market
    • GP-050 Data Protection
    • GP-051 Security violations
    • GP-052 Data Privacy Impact Assessment (DPIA)
    • GP-100 Business Continuity (BCP) and Disaster Recovery plans (DRP)
    • GP-101 Information security
    • GP-200 Remote Data Acquisition in Clinical Investigations
  • Records
  • TF_Legit.Health_Plus
  • Licenses and accreditations
  • External documentation
  • Procedures
  • GP-015 Clinical evaluation
  • Templates
  • T-015-007 Delaration of interest Clinical evaluation team

T-015-007 Delaration of interest Clinical evaluation team

Declaration of interest​

This declaration of interests is made and signed to document the possible conflicts of interest of Clinical evaluator NAME, with DNI 0000000-X, as a participant of the clinical evaluation conducted by AI LABS GROUP S.L. for the PRODUCT NAME medical device.

note

To include the Clinical evaluator NAME education, training, professional experience, self-employment and other relevant data

Clinical evaluator NAME, at present and in the XX months prior to this evaluation (from 20XX), receives economics income in compensation for his work within the organization, not being his main professional activity.

Being certain all the information related regarding to the interests specified previously, Clinical evaluator NAME certifies, under their responsibility, their technical independence in the realization of the clinical evaluation of PRODUCT NAME.

Signature and date
Signature and date
General Manager full name Clinical evaluator full name
note

This is a general template, and it's important to adapt it to each evaluator.

Record signature meaning​

  • Author: JD-004 Author name
  • Review and approve: JD-001 Reviewer and approver name

Template signature meaning​

info

Delete this section when you create a new record from this template.

  • Author: JD-004 María Diez
  • Review: JD-005 Mr. Alfonso Medela
  • Approval: JD-001 Ms. Andy Aguilar
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T-015-006 Clinical investigation report_Study code_es
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T-015-008 Clinical development plan_YYYY_nnn
  • Declaration of interest
  • Record signature meaning
  • Template signature meaning
All the information contained in this QMS is confidential. The recipient agrees not to transmit or reproduce the information, neither by himself nor by third parties, through whichever means, without obtaining the prior written permission of Legit.Health (AI LABS GROUP S.L.)