R-TF-015-004 Clinical Investigation Plan

Scope

The purpose of this Clinical Investigation Plan (CIP) is to set out the rationale, objectives, design, methodology, conduct, implementation, record-keeping and the method of analysis for the clinical investigation.

CIP Identification

	CIP
Title of the clinical investigation	Evaluation of the performance of Legit.Health Plus in automatic triage in teledermatology.
Device under investigation	Legit.Health Plus
Protocol version	Version 2.0
Date	01/01/2026
Protocol code	Legit.Health_triaje_VH_2026
Sponsor	AI LABS GROUP, S.L (Legit.Health)
Coordinating Investigator	Dr. Álvaro Gómez-Tomás
Principal Investigator(s)	Dr. Álvaro Gómez-Tomás, Dr. Jordi Mollet, Dr. Vicente García-Patos
Collaborating Investigator(s)	Alfonso Medela, Taig Mac Carthy
Investigational site(s)	Hospital Universitario Vall D'Hebron
Ethics Committee	Comité de Ética de la Investigación -CEI- del Hospital Universitario Vall D'Hebron

Table of contents

• Scope
• CIP Identification
• Compliance statement
• Abbreviations and Definitions
• CIP or protocol specifications
  • Principal Investigator
  • Coordinating Investigator(s)
  • Collaborating Investigator(s)
  • Investigational sites
  • Funding
• Product Identification and Description
  • Device accountability
• Justification of the design
  • Background and rationale
  • Evaluation of preclinical and clinical data
• Hypothesis
• Objectives
  • Primary objetive(s)
  • Secondary objective(s)
• Summary of the study
• Design and Methods
  • Type of clinical research
  • Population
  • Duration
  • Acceptance criteria
  • Inclusion and exclusion criteria
  • Variables
  • Condition of interest
  • Quality control
  • Limitations of clinical research
• Ethical considerations
  • Data confidentiality
  • Information to subjects and informed consent
  • Bias minimization measures
  • Calendar
  • Monitoring plan
  • Subject follow-up procedures
  • Completition of the investigation
  • Statistical analysis
  • Procedures
  • Data management
• CIP Modification
• CIP Deviations
• Start, follow-up and end reports
• Statements of compliance
• Adverse events, adverse product reactions and product deficiencies
  • Adverse Events (AE) and Adverse Event to Product (AEP)
  • Product deficencies
  • Serious Adverse Events, serios adverse events to product and serious and unexpected adverse event to the product
  • Non-reportable Adverse Events
  • Notification Process
  • Foreseeable adverse events and adverse events to product
  • Emergency contact
  • Data Monitoring Committee (DMC)
• Vulnerable population (if applicable)
• Suspension or early termination of clinical research
• Publication policy
• Bibliography

Compliance statement

The clinical investigation will be conducted according to the Clinical Investigation Plan (CIP) and other applicable guidances and regulations. This includes compliance with:

• The ethical principles originating from the World Medical Association's Declaration of Helsinki
• Harmonized standard UNE-EN ISO 14155:2020
• Regulation (EU) 2017/745 on medical devices (MDR), including the applicable General Safety and Performance Requirements (GSPR) as outlined in Annex I, and the requirements of Annex XV (Chapter I and Chapter II, Section 3)
• Harmonized standard UNE-EN ISO 13485:2016
• MDCG 2024-3 for its structural and content expectations, MDCG 2021-8 concerning application requirements, and MDCG 2020-10/1 Rev 1 for safety reporting timelines and definitions
• Regulation (EU) 2016/679 (GDPR)
• Spanish Organic Law 3/2018 on the Protection of Personal Data and guarantee of digital rights.

All data processing within the device is carried out in accordance with the highest standards of data protection and privacy. Patient information is managed in an encrypted manner to ensure confidentiality and security.

The research team assumes the role of Data Controller, responsible for the collection and management of study data. Legit.Health acts as the Data Processor and is not involved in the processing of patient data.

The storage and transfer of data comply with European data protection regulations. At the conclusion of the study, all information stored in the device will be permanently and securely deleted.

The device employs robust technical and organizational security measures to safeguard personal data against unauthorized access, alteration, loss, or processing.

Abbreviations and Definitions

• AE: Adverse Event
• AEMPS: Spanish Agency of Medicines and Medical Devices
• AEP: Adverse Reaction to Product
• AUC: Area Under the ROC Curve
• CAD: Computer-Aided Diagnosis
• CMD: Data Monitoring Committee
• CIP: Clinical Investigation Plan
• CUS: Clinical Utility Questionnaire
• DLQI: Dermatology Quality of Life Index
• GCP: Standards of Good Clinical Practice
• ICH: International Conference of Harmonization
• IFU: Instructions For Use
• IRB: Institutional Review Board
• N/A: Not Applicable
• NCA: National Competent Authority
• PI: Principal Investigator
• PPV: Positive Predictive Value
• NPV: Negative Predictive Value
• SAE: Serious Adverse Events
• SAEP: Serious Adverse Event to Product
• SUAEP: Serious and Unexpected Adverse Event to the Product
• SUS: System Usability Scale

CIP or protocol specifications

Principal Investigator

Dr. Álvaro Gómez-Tomás, Dr. Jordi Mollet, Dr. Vicente García-Patos University Hospital Vall D'Hebron, Dermatology Service, VHIR and Universitat Autònoma de Barcelona.

Coordinating Investigator(s)

Dr. Álvaro Gómez-Tomás University Hospital Vall D'Hebron, Dermatology Service, VHIR and Universitat Autònoma de Barcelona.

Collaborating Investigator(s)

• Alfonso Medela (AI LABS GROUP SL)
• Taig Mac Carthy (AI LABS GROUP SL)

Investigational sites

University Hospital Vall D'Hebron, Dermatology Service

Funding

Sponsor: AI LABS GROUP, S.L. No external funding sources are anticipated. The associated costs of project execution are privately managed.

Product Identification and Description

	Information
Device name	Legit.Health Plus (hereinafter, the device)
Model and type	NA
Version	1.1.0.0
Basic UDI-DI	8437025550LegitCADx6X
Certificate number (if available)	MDR 792790
EMDN code(s)	Z12040192 (General medicine diagnosis and monitoring instruments - Medical device software)
GMDN code	65975
EU MDR 2017/745	Class IIb
EU MDR Classification rule	Rule 11
Novel product (True/False)	TRUE
Novel related clinical procedure (True/False)	TRUE
SRN	ES-MF-000025345

Device accountability

Given that the investigational device is a Software as a Medical Device (SaMD), product accountability is managed through strict access control to the platform. Access to the software is granted exclusively to authorized investigators during the clinical investigation through secure credentials (username and password). The sponsor will maintain a log of all active accounts and usage metrics associated with the clinical investigation. Upon completion, early termination, or temporary halt of the study, or if a user withdraws consent, their access credentials will be immediately revoked to prevent further use. Malfunctioning software versions or "expired" access rights are similarly managed by restricting access and disabling accounts, ensuring no unauthorized or obsolete product use occurs.

Justification of the design

Background and rationale

In Spain, primary care physicians represent the first line of care in the health system. They respond to the most frequent pathologies, although they often require the support of other medical specialists, such as dermatologists. However, there is a significant shortage of dermatologists in Spain (approximately three dermatologists per 100,000 inhabitants), leading to long waiting lists, sometimes up to a year in some hospitals.

With 15% of the European population suffering from a skin disease and a probability greater than 30% of developing some type of skin cancer over a lifetime, this lack of specialists poses a major challenge. For example, melanoma has registered a 2% increase between 2002 and 2022. Late diagnosis significantly decreases patient survival chances.

In the current Spanish health system, primary care physicians are responsible for deciding whether a patient should be prioritized for specialized dermatological care. This decision depends on a physician who in many cases may only have one month of practical training in Dermatology, which can cause a collapse of the system with the referral of non-urgent pathologies.

Today, many Spanish hospitals have incorporated telemedicine systems (teledermatology). However, these systems still present the same problems in prioritizing and triaging patients according to the severity of their pathology.

Recent advances in artificial intelligence (AI) are revolutionizing many fields, including medicine. The development of diagnostic and triage algorithms now allows identifying and prioritizing cases that require preferential attention. Legit.Health presents an AI-based solution that extracts relevant clinical information from dermatological images to improve decision-making and automate processes, such as patient prioritization based on malignancy or severity criteria.

Evaluation of preclinical and clinical data

These evaluations can be consulted in the T-015-005 Investigator's brochure.

Hypothesis

The implementation of the device in the Hospital Vall d'Hebron promises to significantly transform dermatological care thanks to the advanced artificial intelligence capabilities it offers. This project focuses on optimizing care for patients with skin cancer and severe dermatoses to reduce waiting times, improve accuracy in detecting skin cancer, and decrease the incidence of false positives and negatives.

Objectives

Primary objetive(s)

The main objective of this study is to improve care for patients with skin cancer and severe dermatoses by introducing the Legit.Health teledermatology triage system at the University Hospital Vall d'Hebron (HUVH). It seeks to validate whether the use of this tool reduces waiting times, improves accuracy in skin cancer detection, and decreases the cases of false positives and negatives.

Secondary objective(s)

• Reduction in the average waiting time for patients with cutaneous cancer.
• Evaluate the sensitivity and specificity of Legit.Health in detecting malignancy.
• Monitor image quality and identify non-malignant conditions that require preferential attention, such as toxicodermas and extensive inflammatory dermatoses.

Summary of the study

This is a retrospective study to evaluate the utility of a teleconsultation prioritization algorithm based on machine learning. The study sample consists of image teleconsultations made from Primary Care (adults and pediatrics) to the Dermatology Service from 13/07/2020 to December 2025. A detailed analysis of more than 30,000 referrals and other data will evaluate the tool's performance. The analysis and drafting of the manuscript will be carried out during the year 2026.

Design and Methods

Type of clinical research

Retrospective study to evaluate the utility of a teleconsultation prioritization algorithm based on machine learning.

Population

Patients who had image teleconsultations made from Primary Care (adults and pediatrics) to the Dermatology Service at HUVH between 13/07/2020 and December 2025.

Duration

The sample spans from July 13, 2020, to December 2025. Analysis and reporting during 2026.

Acceptance criteria

• Reduced average waiting times for patients with skin cancer compared to observed historical waiting times.
• Demonstrated sensitivity and specificity for Legit.Health in detecting malignancy.
• Identification of false negatives and false positives correctly flagged by Legit.Health.

Inclusion and exclusion criteria

Inclusion Criteria (Data):

• Image teleconsultations made from Primary Care to the Dermatology Service between 13/07/2020 and December 2025.
• Images with available required variables (sex, birth date, request date, priority, ICSP text, etc.).

Exclusion Criteria:

• Exclude data without corresponding images or minimum necessary ICSP metadata.

Variables

The main information will be the image, essential for processing through Legit.Health AI. Other necessary variables include:

• ICSP patient sex (Binary).
• ICSP patient phototype (I, II, III, IV, V and VI).
• ICSP patient birth date (Numeric: Month/year).
• ICSP request date (Date).
• ICSP request priority (Binary: NORMAL / PREFERENTE).
• ICSP request text (Text: Reason for referral and orientation).
• Number of attached images ICSP (Numeric).
• Attached images ICSP (Image).
• Diagnostic code associated with the ICSP (Text).
• Response/closure date ICSP by Dermatology team (Date).
• Clinical course of Dermatology at ICSP closure date (Text).
• Existence of an order for first visit in Dermatology issued on the same closure date (Binary).
• Date of order for first visit (Date).
• Priority of the order for first visit (Binary).
• Destination of the first visit (Binary: RAE vs CEX DERMATOLOGY).
• Text of the order for first visit (Text).
• Scheduling date of first visit (Date).
• Clinical course Dermatology on the date of first visit (Text).
• First visit diagnostic code Dermatology (Text).
• Biopsy request on the same date as first visit (Binary).
• SNOMED code for biopsy result (Text).
• Biopsy associated with the episode having a malignancy diagnosis (Binary).
• Existence of order issued for IQ or Plastic Surgery (Binary).
• Existence of successive visit in Dermatology or episode closure (Binary).

Condition of interest

Evaluation of performance in automatic teledermatology triage (prioritization of skin cancer and severe dermatoses).

Quality control

Strict data handling procedures will be implemented to ensure data confidentiality and integrity. Images will not be anonymized if they contain faces to ensure the precision and effectiveness of the algorithm. However, at no time will researchers have access to the identity of the patients, as direct identifying information will be removed. All data, including images, will be permanently deleted after the study concludes.

Limitations of clinical research

The main limitation of this study lies in the quality of the collected images. Factors such as variability in lighting, color, shape, size, and focus are determinant. There may be high intra-patient variability. To mitigate this limitation, Legit.Health software will evaluate the quality of the taken image through the Dermatology Image Quality Assessment, thereby reducing the capture of low-quality images.

Ethical considerations

This study adhered to international Good Clinical Practice (GCP) guidelines, the Declaration of Helsinki in its latest amendment, and applicable international and national regulations. As applicable, approval from the relevant Ethics Committee was obtained prior to the initiation of the study. When applicable, modifications to the protocol were reviewed and approved by the Principal Investigator (PI) and subsequently evaluated by the Ethics Committee before subjects were enrolled under a modified protocol.

This study was conducted in compliance with European Regulation 2016/679, of 27 April, concerning the protection of natural persons with regard to the processing of personal data and the free movement of such data (General Data Protection Regulation, GDPR), and Organic Law 3/2018, of 5 December, on the Protection of Personal Data and the guarantee of digital rights. In accordance with these regulations, no data enabling the personal identification of participants was collected, and all information was managed securely in an encrypted format.

Participants were informed both orally and in writing about all relevant aspects of the study, with the information being tailored to their level of understanding. They were provided with a copy of the informed consent form and the accompanying patient information sheet. Adequate time was given to patients to ask questions and fully comprehend the details of the study before providing their consent.

The PI was responsible for the preparation of the informed consent form, ensuring it included all elements required by the International Conference on Harmonisation (ICH), adhered to current regulatory guidelines, and complied with the ethical principles of GCP and the Declaration of Helsinki.

The original signed informed consent forms were securely stored in a restricted access area under the custody of the PI. These documents remained at the research site at all times. Participants were provided with a copy of their signed consent form for their records.

Data confidentiality

All personal data will be anonymized to safeguard patient privacy. Unique and non-identifiable identifiers will be assigned to each teleconsultation, removing any direct information that could link to specific individuals. Only researchers from the HUVH Dermatology department will have access to the equivalence of numerical codes with patient data to match them if necessary. Images containing faces will not be masked, but they are completely separated from patient identity. Access to the collected data will be restricted to an authorized group of professionals directly involved in the validation.

Information to subjects and informed consent

Due to the retrospective nature of the study utilizing anonymized records of past clinical encounters, direct patient consent is waived in accordance with current data protection regulations for historical research, provided that robust security and anonymization protocols are implemented.

Bias minimization measures

To mitigate image quality bias, the algorithm includes a module for Dermatology Image Quality Assessment (DIQA).

Calendar

Sample period: July 2020 to December 2025. Analysis and manuscript drafting: 2026.

Monitoring plan

N/A - Retrospective study.

Subject follow-up procedures

N/A - Retrospective study.

Completition of the investigation

The study concludes after the comparative analysis between observed waiting times and possible waiting times post-triage using the algorithm is completed. A final study report will be executed.

Statistical analysis

A comparative analysis will be performed between the observed waiting times and the possible waiting times after prioritization/triage using Legit.Health Plus. Additionally, an analysis of concordance between the artificial intelligence tool, dermatologists, and primary care physicians will be carried out using appropriate statistical tests based on the nature of the variables.

Procedures

Retrospective collection of over 30,000 teleconsultations from the hospital PACS and clinical systems. Relevant metadata and images are extracted and processed through the Legit.Health AI. The AI's prioritization (priority level and malignancy estimation) is then statistically compared to the historical outcomes and ground truth (e.g., biopsies, dermatologist clinical course).

Data management

The data will be managed and tabulated with consistency rules and logical ranges to control inconsistencies during data tabulation. A validation process of the clinical data will be carried out by running computer filters based on validation rules, which will automatically identify missing values or inconsistencies of clinical data according to the protocol. Additionally, manual editing and validation will be performed using descriptive and exploratory statistical techniques to complement the detection of logical errors and inconsistent values.

The database will be considered closed upon completion of all data management processes and satisfactory resolution of discrepancies and errors in the data. Any changes in the database after its closure can only be made after written agreement between the Principal Investigator and the technical coordinators of the project.

AI Labs Group, S.L. (hereinafter, the manufacturer) is the owner of the device. During the period of validity of this study, the manufacturer will grant a license to use the device by the research team free of charge. The research team will be the administrator of the account. Both patients and members of the medical team will have login credentials. The manufacturer will not have access to the account or patient information.

According to the definitions and roles set out in Regulation (EU) 2016/679 (GDPR), the Data Controller is the research team and the manufacturer is the Data Processor.

The storage of data and photographs will be in line with the European Regulation 2016/679 (GDPR) and the Organic Law 3/2018 of 5 December on the Protection of Personal Data and guarantee of digital rights. At the end of the study, all information stored in the device will be totally and permanently deleted.

The device complies with current legislation on the protection and confidentiality of personal data European Regulation 2016/679 (GDPR). Appropriate technical and organizational security measures are adopted to ensure the security of personal data and prevent its alteration, loss, unauthorized processing or access, given the state of technology, the nature of the data and the risks to which they are exposed, whether from human action or the natural physical environment.

CIP Modification

As indicated in the UNE-EN ISO 14155:2021 standard, the Clinical Investigation Plan (CIP) may be modified as necessary during the clinical investigation. The changes made must be described, along with their justification, potential impact on clinical performance, efficacy, safety, or other evaluation criteria, and identification of other affected documents.

CIP modifications will be prepared by the sponsor and agreed upon and accepted between the sponsor and the principal investigator. The modifications will be recorded with a justification for each one in the form of an amendment or addendum.

The required regulatory authority (AEMPS) and the Ethics Committee or Institutional Review Board (IRB) will be notified, if necessary. Modifications to the clinical investigation may only be implemented once favourable feedback and the corresponding approval have been obtained.

In accordance with Article 75 of Regulation (EU) 2017/745, substantial modifications to the clinical investigation must be approved by both the Ethics Committee for investigation with medicines (CEIm) and the Competent Authority (AEMPS) prior to their implementation.

• In the case of substantial modifications to authorized clinical investigations, a request must be submitted to the AEMPS and the CEIm.
• For non-substantial modifications to authorized clinical investigations, until the corresponding module is available in the EUDAMED database, the updated documentation will be sent to the AEMPS for inclusion in their file.

CIP Deviations

As indicated in the UNE-EN ISO 14155:2021 standard, the investigator may not deviate from the Clinical Investigation Plan (CIP), except in emergencies (section 4.5.4.b of the standard). In such cases, the investigator may proceed without prior approval from the sponsor and the Ethics Committee to protect the rights, safety, and well-being of human subjects. The use of waivers from the Clinical Investigation Plan is strictly prohibited.

These deviations must be documented by the principal investigator and notified to the sponsor and the IRB as soon as possible, and always within a maximum of 15 days. Immediately after receiving the notification, the sponsor will record and analyze the deviations carried out and their potential impact. Depending on the findings, the sponsor will take the necessary corrective and/or preventive measures.

In other circumstances, when deviations affect the rights, safety, and well-being of the subject or the scientific integrity of the clinical investigation, deviation requests and reports must be provided to the IRB if required.

Start, follow-up and end reports

The start of the study will be notified to the ethics committee.

Upon obtaining the study conclusions, a final report (T-015-006 Clinical Investigation Report (CIR)) will be prepared and submitted to the ethics committee.

Statements of compliance

The present clinical investigation will be conducted following the ethical principles originating from the Declaration of Helsinki.

Additionally, the clinical investigation will comply with the harmonized standard UNE-EN ISO 14155:2021 and the European Regulation MDR 2017/745. The statement specifying compliance with the general safety and performance requirements in accordance with MDR can be found in the document Manufacturer's Declaration of Compliance with Requirements.

As appropiate, clinical investigation will not commence until approval/favourable opinion has been obtained from the Clinical Research Ethics Committee (CREC) and the required regulatory authority (Spanish Agency for Medicines and Medical Devices, AEMPS), and it must comply with any additional requirements imposed by the CREC and/or AEMPS.

The statement regarding the funding of the clinical investigation, along with the description of the agreement between the sponsor and the research centers and between the sponsor and the principal investigator, can be found in the Clinical Trial Agreement (CTA) and can be accessed upon request.

Adverse events, adverse product reactions and product deficiencies

Adverse Events (AE) and Adverse Event to Product (AEP)

An AE is any unintended medical event, unanticipated illness or injury, or unintended clinical signs (including abnormal laboratory findings) in subjects, users, or other persons, whether or not related to the investigational product and whether intended or unintended.

A AEP is an adverse event related to the use of an investigational medical device.

Given these definitions, potential AEPs or AEs are documented in the product's IFU.

Product deficencies

Possible inadequacies of a medical device may relate to its identity, quality, durability, reliability, safety, or performance.

Considering this definition, the following issues could arise:

• Malfunctions, such as application crashes or failure to process images.
• Use errors, such as capturing poor quality photographs or incorrect data entry.
• Inadequate information provided by the manufacturer, such as a complex IFU and/or labeling.

Product deficiencies in the investigation will be managed by the sponsor according to non-conforming product control procedures. When appropriate, corrective and/or preventive actions will be taken to protect the safety of subjects, users, and individuals.

Serious Adverse Events, serios adverse events to product and serious and unexpected adverse event to the product

According to UNE-EN ISO 14155:2021:

• A Serious Adverse Product Reaction (SAEP) is a SAE that has produced any consequence characteristic of a serious adverse event.
• A Serious Adverse Event (SAE) is an AE that resulted in any of the following events: death, serious deterioration of the health status of the subject, users or other persons, or fetal distress, fetal death, congenital anomaly or birth defect.
• A Serious Unexpected Adverse Event to the Product (SUAEP) is a SAE that, due to its nature, incidence, intensity or consequences, has not been identified in the updated risk assessment.

Taking into account these definitions, there are no SAEP, SAEs or SUAEPs related to the use of the product.

Non-reportable Adverse Events

note

List non-reportable adverse events, if applicable, including justification.

There are no specific non-reportable adverse events defined for this study. Since this is an retrospective observational study using a digital tool without therapeutic intervention, subjects are not exposed to any procedures that could endanger their safety, and no adverse events related to the investigational product are expected.

Notification Process

Any SAEP, product deficiency or finding related to the above will be duly documented and reported in accordance with the provisions of document MDCG 2020-10/1 “Safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017/745”

In the situations detailed in the previous paragraph, the principal investigator must notify the sponsor immediately (but no later than 3 days after becoming aware of the event). The sponsor will then use the form published as an annex to said document, MDCG 2020-10/2 “Guidance safety report form”.

This form must be completed or updated for each reportable event or for new findings or updates of events already reported. It will be transmitted to all National Competent Authorities (NCA) where the clinical investigation is being conducted. In this case, the AEMPS.

The notification period of the sponsor to the NCA(s) will be immediately (but no later than 2 days after becoming aware of the event) for reportable events that involve an imminent risk of death, serious injury or serious illness and that require immediate corrective action, or new findings or updates of related events. For the rest of reportable events or new findings or updates, the notification period will be immediately (but no later than 7 days after becoming aware of the event).

Likewise, as indicated in the UNE-EN ISO 14155:2021 regulation, the IRB must be notified of the SAEs, if the IRB so requires.

Foreseeable adverse events and adverse events to product

The foreseeable adverse events and expected adverse reactions to the product, as well as their incidence, mitigation and treatment are documented in the T-013-002 Risk management record of the product under study.

Emergency contact

The emergency contact person for reporting serious adverse events and serious adverse effects of the product:

• Name: Dr. Álvaro Gómez-Tomás
• Professional role: Principal Investigator
• E-mail: alvaro.gomez@vallhebron.cat

Data Monitoring Committee (DMC)

Information on the DMC (Data Monitoring Committee), if established. This is an independent committee that the sponsor may establish to evaluate, at indicated intervals, the progress of the clinical investigation, the safety data or the critical clinical performance or efficacy endpoints and to recommend to the sponsor whether to continue, suspend, modify, or stop the clinical investigation.

Vulnerable population (if applicable)

N/A

Suspension or early termination of clinical research

As indicated in the UNE-EN ISO 14155:2021 regulation, the sponsor may suspend or terminate the clinical research early for significant and documented reasons. These are:

• If during the clinical research the suspicion of an unacceptable risk arises, including a serious threat to the health of the subjects. It must be suspended while the risk is determined.
• If an unacceptable risk that cannot be controlled is confirmed.
• Due to the impossibility of including a minimum number of subjects that allows the final assessment of the study within a reasonable period according to the characteristics of the study.
• When instructed by the IRB or the required regulatory authority (AEMPS).
• Due to non-compliance with the obligations assumed in the contract by any of the contracting parties.
• By mutual agreement between the parties, expressed in writing.
• By the will of one of the parties, expressed in writing at least one month in advance.

In the event of a suspension or early termination of the clinical research, the sponsor will inform the AEMPS. The sponsor must provide the resources to comply with the obligations of the CIP and with the existing agreements. The principal investigator must inform the subjects if so stipulated in the agreement between the sponsor and the research centre.

If the clinical investigation is resumed, the sponsor must inform the principal investigator and, where appropriate, the AEMPS. Approval from the IRB and, where appropriate, from the AEMPS will be required for such resumption. The principal investigator must inform the subjects.

In accordance with Article 77 of Regulation (EU) 2017/745, the sponsor must notify the Member States in which the clinical investigation is being conducted of the end of the clinical investigation, its temporary halt, or its early termination, within the deadlines specified by the regulation (within 15 days of the end, or within 24 hours in case of early termination or temporary halt for safety reasons). This notification must be accompanied by a justification in case of early termination or temporary halt.

Publication policy

The results of this study will be widely disseminated through various platforms, including the publication of articles in scientific journals, presentation at specialized medical congresses, as well as dissemination in mass media aimed at the general public.

In accordance with the legal requirements and ethical principles established in Section 1 of Chapter I of Annex XV of Regulation (EU) 2017/745, a Clinical Investigation Report (T-015-006 Clinical Investigation Report (CIR)) will be prepared within one year of the end of the clinical investigation or within three months of its early termination or temporary halt. The CIR will be provided to the IRB and the AEMPS.

The results of the clinical investigation will be published in the aforementioned public database. The summary of the clinical investigation report and its results (whether positive, negative, or inconclusive) will be made available to the public within 1 year from the end of the clinical investigation, or within 3 months in the event of early termination or temporary halt.

In addition, if deemed appropriate, the results obtained will be published in scientific journals. The CEIC that has approved this clinical research will be mentioned, and the funds obtained by the author for or for its conduct and the source of funding will be stated. The anonymity of the subjects participating in the clinical research will be maintained at all times.

Bibliography

References can be consulted in the original PDF protocol document.

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 Design & Development Manager, JD-004 Quality Manager & PRRC
• Approver: JD-001 General Manager

ㅤ