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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
        • T-015-010 Annex E ISO 14155
    • 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 Usability and Human Factors Engineering
    • GP-027 Corporate Governance
    • 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
    • GP-026 Market-specific product requirements
  • Records
  • Legit.Health Plus Version 1.1.0.0
  • Legit.Health Plus Version 1.1.0.1
  • Licenses and accreditations
  • External documentation
  • Procedures
  • GP-015 Clinical evaluation
  • Templates
  • T-015-010 Annex E ISO 14155

T-015-010 Annex E ISO 14155

Scope​

This document contains all the essential documentation required before, during, and after a clinical investigation.

Document TitlePurposeIncludedJustification if not provided
Investigator's BrochureProvides clinical and non-clinical data on the investigational device relevant to its study in human subjects.
Clinical Investigation Plan (CIP)Describes the rationale, objectives, design, methodology, monitoring, and conduct of the clinical investigation.
Subject Information Sheet and Informed Consent Form (ICF)Ensures that potential study subjects are adequately informed about the investigation and provide voluntary consent.
Ethics Committee ApprovalOfficial approval from the ethics committee to conduct the clinical investigation.
Regulatory Authority AuthorizationAuthorization or notification from relevant regulatory bodies to proceed with the clinical investigation.
Case Report Forms (CRFs)Documents designed to record all protocol-required information to be reported to the sponsor on each trial subject.
Monitoring PlanDescribes the strategy, methods, responsibilities, and requirements for monitoring the clinical investigation.
Subject Recruitment MaterialsMaterials used to recruit subjects, ensuring they are ethically and appropriately informed.
Signed AgreementsContracts between the sponsor, investigators, and institutions detailing roles and responsibilities.
Delegation of Duties LogDocuments identifying the study-related duties and responsibilities assigned to each team member.
Training RecordsEvidence of training provided to the investigation team on the CIP, investigational device, and GCP principles.
Investigational Device Accountability RecordsTracks the receipt, use, and disposition of the investigational device to ensure traceability.
Subject Identification Code ListConfidential list linking subjects' codes to their identities, maintained by the investigator.
Screening and Enrollment LogsDocuments tracking the screening and enrollment status of potential and actual study subjects.
Investigational Device Dossier (IDD)Comprehensive technical and clinical data on the investigational device, including design, manufacturing, and performance information.
Insurance StatementProof of insurance coverage for participants in case of study-related injuries.
Financial Disclosure RecordsDocumentation of any financial interests of investigators that could affect the study's integrity.
Audit CertificatesReports from independent audits assessing compliance with the CIP and GCP.
Final Clinical Investigation ReportA comprehensive report summarizing the clinical investigation's methodology and results.
info

If any of the documents listed do not apply or have not been prepared for the study in question, it is necessary to provide a justification and explain why.

Furthermore, if the document is not attached to the Trial Master File, the location of the document must be clearly justified, and it should be specified whether access requires an explicit request to the study sponsor.

Signature meaning

The signatures for the approval process of this document can be found in the verified commits at the repository for the QMS. As a reference, the team members who are expected to participate in this document and their roles in the approval process, as defined in Annex I Responsibility Matrix of the GP-001, are:

  • Author: Team members involved
  • Reviewer: JD-003, JD-004
  • Approver: JD-001
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  • Scope
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.)