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          • R-TF-015-006 Clinical investigation report_LEGIT_URT_EVCDAO_2020
        • R-TF-015-004 Clinical investigation plan LEGIT.HEALTH_BI_2024
        • R-TF-015-004 Clinical investigation plan LEGIT.HEALTH_DAO_Derivación_O_2022.
        • R-TF-015-004 Clinical investigation plan LEGIT.HEALTH_DAO_Derivación_PH_2022.
        • R-TF-015-004 Clinical investigation plan LEGIT.HEALTH_PH_2024_NIPPLE
        • R-TF-015-004 Clinical investigation plan LEGIT.HEALTH_SAN_2024
        • R-TF-015-004 Clinical investigation plan LEGIT_COVIDX_EVCDAO_2022
        • R-TF-015-004 Clinical investigation plan LEGIT_MC_EVCDAO_2019
        • R-TF-015-004 Clinical investigation plan LEGIT.HEALTH_DAO_Derivación_O_2022.
        • R-TF-015-004 Clinical investigation plan Legit.Health_IDEI_2023.
        • R-TF-015-006 Clinical investigation report LEGIT.HEALTH_BI_2024
        • R-TF-015-006 Clinical investigation report LEGIT.HEALTH_DAO_Derivación_O_2022
        • R-TF-015-006 Clinical investigation report LEGIT.HEALTH_DAO_Derivación_PH_2022
        • R-TF-015-006 Clinical investigation report LEGIT.HEALTH_PH_2024
        • R-TF-015-006 Clinical investigation report LEGIT.HEALTH_PH_2024_NIPPLE
        • R-TF-015-006 Clinical investigation report LEGIT.HEALTH_SAN_2024
        • R-TF-015-006 Clinical investigation report LEGIT_COVIDX_EVCDAO_2022
        • R-TF-015-006 Clinical investigation report LEGIT_MC_EVCDAO_2019
        • R-TF-015-006 Clinical investigation report Legit.Health_IDEI_2023
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  • R-TF-015-006 Clinical investigation report_LEGIT_URT_EVCDAO_2020

R-TF-015-006 Clinical investigation report_LEGIT_URT_EVCDAO_2020

Research Title​

Research Description​

info

If it is not clearly evident from the title itself, provide a single sentence describing the study design, comparison, duration, method of use, and the subject population.

Product Identification​

Promoter Identification and Contact​

CIP Identification​

Public Access Database​

Research Team​

Compliance Statement​

This clinical research has been conducted in accordance with the harmonized standard UNE-EN ISO 14155:2021 and European Regulation MDR 2017/745.

Report Date​

Report Author(s)​

Table of contents

  • Research Title
  • Research Description
  • Product Identification
  • Promoter Identification and Contact
  • CIP Identification
  • Public Access Database
  • Research Team
  • Compliance Statement
  • Report Date
  • Report Author(s)
  • Abbreviations and Definitions
  • Summary
    • Title
    • Introduction
    • Objectives
    • Population
    • Design and Methods
    • Results
    • Conclusions
  • Introduction
  • Materials and methods
    • Product Description
    • Clinical Research Plan
  • Results
    • Initiation and Completion Date
    • Subject and Investigational Product Management
    • Subject Demographics
    • CIP (Clinical Investigation Plan) Compliance
    • Analysis
  • Discussion and Overall Conclusions
    • Clinical Performance, Efficacy, and Safety
    • Clinical Risks and Benefits
    • Clinical Relevance
    • Specific Benefit or Special Precaution
    • Implications for Future Research
    • Limitations of Clinical Research
  • Ethical Aspects of Clinical Research
  • Investigators and Administrative Structure of Clinical Research
    • Brief Description
    • Investigators
    • External Organization
    • Promoter and Monitor
  • Signature Page
  • Report Annexes
  • Record signature meaning

Abbreviations and Definitions​

Summary​

Title​

Introduction​

Objectives​

Population​

Design and Methods​

Design​

Number of Subjects​

Initiation Date​

Completion Date​

Duration​

Methods​

Results​

Conclusions​

Introduction​

info

The introduction should contain a brief statement framing the clinical research in the context of product development under investigation and linking critical aspects of clinical research (e.g., objectives and hypotheses, target population, treatment, and follow-up duration) with such development. Any guidelines followed in CIP (Clinical Investigation Plan) development or any other agreements/meetings between the promoter and regulatory authorities relevant to the specific clinical research should be identified or described.

Materials and methods​

Product Description​

Product Description​

Intended Purpose of the Product​

Intended Previous Uses​

Product Changes During Clinical Research​

Clinical Research Plan​

info

Provide a summary of the CIP (Clinical Investigation Plan), including any subsequent modifications with justification for each modification. The summary should include a brief description of the points indicated below.

Objectives​

Design (type of research, assessment criteria, methods, active group, and control group)​

Ethical Considerations​

Data Quality Assurance​

Subject Population (inclusion/exclusion criteria and sample size)​

Treatment​

Concomitant Medication/Treatment​

Follow-Up Duration​

Statistical Analysis​

info

Include hypotheses or success/failure criteria, sample size calculation, statistical analysis methods, and interim analyses, where applicable.

Results​

Initiation and Completion Date​

info

The initiation date of the clinical research and the completion/suspension date of the clinical research.

Subject and Investigational Product Management​

info

Management of subjects (number screened, randomized, and received therapy) and disposition of investigational products.

Subject Demographics​

CIP (Clinical Investigation Plan) Compliance​

Analysis​

info

There should be a clear distinction between primary analyses, other pre-specified analyses, and additional analyses.

Clinical Performance, Efficacy, and Safety​

info

An analysis of performance and results based on the evaluation criteria specified in the CIP (Clinical Investigation Plan).

Adverse Events and Adverse Reactions to the Product​

info

A summary of all adverse events and adverse reactions to the product, including a discussion of the significance and severity of the event, necessary treatment, resolution, and the competent principal investigator's opinion on the causal relationship with the investigational products or procedures.

Product Deficiencies​

info

A table summarizing all observed product deficiencies that could have caused a serious adverse reaction to the product and any corrective actions taken during the clinical research.

Subgroup Analysis for Special Populations​

info

Any subgroup analysis required for special populations (e.g., sex, racial/cultural/ethnic subgroups), as applicable.

Accounting for All Subjects​

info

Description of how missing data or deviations in the analysis were handled, including subjects who did not pass screening, were lost to follow-up, withdrew, or had their participation terminated prematurely and the reasons for such.

Discussion and Overall Conclusions​

Clinical Performance, Efficacy, and Safety​

info

Results of safety and performance and any other assessment criteria.

Clinical Risks and Benefits​

Clinical Relevance​

info

A discussion of the clinical relevance and importance of the results in light of other existing data and the state of the art.

Specific Benefit or Special Precaution​

Implications for Future Research​

Limitations of Clinical Research​

info

Any limitations of clinical research (subject selection, retention, and compliance; investigator and user selection, retention, and compliance; bias introduced by lack of data, confounding factors, etc.).

Ethical Aspects of Clinical Research​

info

This section should include:

  • Confirmation that the EC reviewed the CIP (Clinical Investigation Plan) and any amendments (if required).
  • Enumeration of all consulted ECs.
  • Confirmation that the research was conducted in accordance with the ethical principles of the Helsinki Declaration.
  • A statement that informed consent was obtained and when it was obtained.

Investigators and Administrative Structure of Clinical Research​

Brief Description​

Investigators​

info

A list of investigators, including their institutional affiliation.

External Organization​

info

The names and addresses of any third parties (such as central laboratories, CROs, consultants, and other contractors) who contributed to clinical research.

Promoter and Monitor​

Signature Page​

info

Signatures of the promoter and the coordinating investigator(s) indicating their agreement with the content of the clinical research report. If no coordinating investigator has been appointed, the signatures of the principal investigators should be obtained. Signature pages can be included separately from the clinical research report itself.

Report Annexes​

info

Annexes to the report may contain the following information:

  • The CIP, including amendments.
  • Instructions for use.
  • A list of principal investigators and the research centers to which they are affiliated, including a summary of their qualifications or a copy of their CVs.
  • A list of collaborating investigators and the research centers to which they are affiliated, including a summary of their qualifications or a copy of their CVs.
  • A list of the names and addresses of any third parties (such as central laboratories, CROs, consultants, and other contractors) who contributed to clinical research.
  • A list of monitors.
  • A list of ECs.
  • Tabulation of all relevant datasets, including:
  • Deviations from the CIP that affected subject rights, safety, or welfare, or the scientific integrity of clinical research.
  • All adverse events, adverse reactions to the product, and product deficiencies.
  • Withdrawals and suspensions.
  • The audit certificate, if applicable.

Record signature meaning​

  • Author: JD-00X Author name
  • Reviewer: JD-003 Taig Mac Carthy
  • Approval: JD-005 Approver name
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R-TF-015-004 Clinical investigation plan LEGIT.HEALTH_BI_2024
  • Research Title
  • Research Description
  • Product Identification
  • Promoter Identification and Contact
  • CIP Identification
  • Public Access Database
  • Research Team
  • Compliance Statement
  • Report Date
  • Report Author(s)
  • Abbreviations and Definitions
  • Summary
    • Title
    • Introduction
    • Objectives
    • Population
    • Design and Methods
      • Design
      • Number of Subjects
      • Initiation Date
      • Completion Date
      • Duration
      • Methods
    • Results
    • Conclusions
  • Introduction
  • Materials and methods
    • Product Description
      • Product Description
      • Intended Purpose of the Product
      • Intended Previous Uses
      • Product Changes During Clinical Research
    • Clinical Research Plan
      • Objectives
      • Design (type of research, assessment criteria, methods, active group, and control group)
      • Ethical Considerations
      • Data Quality Assurance
      • Subject Population (inclusion/exclusion criteria and sample size)
      • Treatment
      • Concomitant Medication/Treatment
      • Follow-Up Duration
      • Statistical Analysis
  • Results
    • Initiation and Completion Date
    • Subject and Investigational Product Management
    • Subject Demographics
    • CIP (Clinical Investigation Plan) Compliance
    • Analysis
      • Clinical Performance, Efficacy, and Safety
      • Adverse Events and Adverse Reactions to the Product
      • Product Deficiencies
      • Subgroup Analysis for Special Populations
      • Accounting for All Subjects
  • Discussion and Overall Conclusions
    • Clinical Performance, Efficacy, and Safety
    • Clinical Risks and Benefits
    • Clinical Relevance
    • Specific Benefit or Special Precaution
    • Implications for Future Research
    • Limitations of Clinical Research
  • Ethical Aspects of Clinical Research
  • Investigators and Administrative Structure of Clinical Research
    • Brief Description
    • Investigators
    • External Organization
    • Promoter and Monitor
  • Signature Page
  • Report Annexes
  • Record 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.)