R-TF-015-004 Clinical investigation plan LEGIT_COVIDX_EVCDAO_2022
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 | Clinical Validation of a Computer-Aided Diagnosis (CAD) System Utilizing Artificial Intelligence Algorithms for Continuous and Remote Monitoring of Patient Condition Severity in an Objective and Stable Manner. |
| Device under investigation | Legit.Health |
| Protocol version | Version 2.0 |
| Date | 2022-03-03 |
| Protocol code | LEGIT_COVIDX_EVCDAO_2022 |
| Sponsor | AI Labs Group S.L. |
| Coordinating Investigator | Dra. Marta Andreu |
| Principal Investigator(s) | Dra. Marta Andreu |
| Investigational site(s) | Torrejón University Hospital |
| Ethics Committee | Comité de Ética de la Investigación con Medicamentos de los Hospitales Universitarios Torrevieja y Elche-Vinalopó |
Table of contents
- Scope
- CIP Identification
- Compliance statement
- Abbreviations and definitions
- CIP or protocol specifications
- Product Identification and Description
- Justification of the design
- Hypothesis
- Objectives
- Summary of the study
- Design and methods
- Ethical considerations
- CIP Modification
- CIP Deviations
- Start, follow-up and end reports
- Statements of compliance
- Informed Consent process
- Adverse events, adverse product reactions and product deficiencies
- Annexes
- Record signature meaning
Compliance statement
- Harmonized standard UNE-EN ISO 14155:2021.
- Regulation (EU) 2017/745 on medical devices (MDR).
- Harmonized standard UNE-EN ISO 13485:2016s.
- Regulation (EU) 2016/679 (GDPR).
- Spanish Organic Law 3/2018 on the Protection of Personal Data and guarantee of digital rights`.
- Spanish Organic Law 1090/2015 on regulating clinical trials with medicines, the Ethics Committees for Research with Medicines and the Spanish Registry of Clinical Studies.
Abbreviations and definitions
- CAD: Computer-Aided Diagnosis
- CIP: Clinical Investigation Plan
- CUS: Clinical Utility Questionnaire
- SUS: System Usability Scale
- GCP: Standards of Good Clinical Practice
- ICH: International Conference of Harmonization
- PI: Principal Investigator
- DLQI: Dermatology Quality of Life Index
- ICH: International Conference of Harmonization
- AUC: Area Under the ROC Curve
CIP or protocol specifications
Principal Investigator
- Dra. Marta Andreu Barasoain (Hospital Universitario de Torrejón).
Coordinating investigator
- Dra. Marta Andreu Barasoain (Hospital Universitario de Torrejón).
Collaborating Investigator(s)
- Hospital Universitario de Torrejón
- Dr. Leticia Calzado (Chief of Dermatology).
- Dr. Elena Sánchez-Largo (Attending Dermatology Physician).
- Dr. Javier Alcántara (Attending Dermatology Physician).
- Dr. Tania Marusia Capusan (Attending Dermatology Physician).
- Dr. Marta Ruano (Attending Dermatology Physician).
- AI Labs Group S.L.
- Mr. Alfonso Medela.
- Mr. Taig Mac Carthy.
Investigational sites
- Hospital Universitario de Torrejón
Funding
This research was carried out without any funding or sponsorship.
Product Identification and Description
| Information | |
|---|---|
| Device name | Legit.Health Plus (hereinafter, the device) |
| Model and type | NA |
| Version | 1.0.0.0 |
| 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 |
| Class | Class IIb |
| Classification rule | Rule 11 |
| Novel product (True/False) | FALSE |
| Novel related clinical procedure (True/False) | FALSE |
| SRN | ES-MF-000025345 |
Justification of the design
Background and rationale
The COVID-19 pandemic has disrupted healthcare systems globally, particularly in managing non-urgent medical conditions, including dermatology. The reduction of in-person consultations has left many dermatological patients without timely care, exacerbating conditions such as skin cancer and chronic diseases like psoriasis and eczema. The pandemic has underscored the critical need for an efficient, remote diagnostic system to ensure continuous monitoring and timely intervention for dermatological conditions, particularly in countries with an already imbalanced ratio of dermatologists to patients.
Currently, the diagnosis and monitoring of dermatological conditions heavily rely on subjective human assessments, which are prone to inconsistencies and biases. Physicians face challenges in quantifying lesions or disease severity accurately, and patient-reported outcomes often lack reliability. This situation has been further complicated by COVID-19, as patients avoid in-person visits, leading to delayed diagnoses and worsening of conditions. There is an urgent need for reliable tools that can support remote diagnosis and activity tracking of skin pathologies, which would reduce the risks of transmission while maintaining high standards of care.
This study seeks to address these challenges by clinically validating an innovative artificial intelligence (AI) tool designed for remote and continuous monitoring of dermatological conditions. Leveraging the Legit.Health platform, this AI-powered tool can enhance diagnostic precision, reduce human error, and improve the management of chronic skin diseases. By enabling patients to be evaluated from home and providing physicians with a more objective measurement tool, this technology has the potential to improve both patient outcomes and healthcare efficiency.
Risks and benefits of the product in investigation and clinical research
Participants in this study did not undergo any procedures posing a risk to their safety. However, using the device could optimize patient diagnosis, save costs and time, and provide better treatment to patients.
Hypothesis
Legit.Health Plus can perform remote monitoring of pathology severity in a continuous and objective manner. Moreover, it is a very useful tool to reduce the need for a patient to visit the doctor so often, since it is possible to monitor the evolution of the pathology remotely, thus increasing their empowerment, with the consequent reduction in the number of face-to-face consultations in hospitals.
Objectives
Primary objective
To ascertain the validity of the device, leveraging artificial intelligence and developed by AI Labs Group S.L., in objectively and reliably tracking the progression of chronic dermatological conditions. This validation is deemed successful if the tool achieves a score of 8 or higher in the Clinical Utility Questionnaire (CUS).
Secondary objective(s)
- Confirming that the utilization of the device elicits a high level of patient satisfaction, particularly in its remote application.
- Demonstrating that the implementation of the device leads to a reduction in face-to-face consultations, thereby optimizing healthcare resources and patient convenience.
- Validating the device's ability to consistently generate reliable condition monitoring, thereby establishing its trustworthiness as a monitoring system.
Summary of the study
This is a prospective, observational and analytical study designed to evaluate the effectiveness of the device in remotely monitoring chronic dermatologic pathologies. The research encompassed a diverse cohort of 180 patients, which are pretended to represent the studied population with various dermatological conditions. Data collection will include questionnaires, photograph analysis, and patient satisfaction surveys. The study adhered to strict ethical guidelines, ensuring patient confidentiality and compliance with international standards. Patients were provided with detailed information and informed consent. The study's robust methodology aimed to assess the clinical utility and usability of the device.
Design and methods
Type of clinical research
This is an observational and analytical study for the performance of the device monitoring patients with different skin conditions. There is a single group of participants and there is no control group, since we pretend to know the opinion of the dermatologists about the clinical utility of Legit.Health to monitore patients treated at the Dermatology Unit of the Torrejón University Hospital and its usefulness in medical consultations. We want to know also the opinion of patients with the medical device, aiming to understand the opinion of all intended users.
Population
Adult patients (>18 years) diagnosed with any of the specified chronic dermatological conditions that meet the inclusion criteria. These patients will be attended at the Dermatology Department of the Hospital Universitario de Torrejón.
Duration
This study estimates a recruitment period of 6 months.
The total duration of the study is estimated at 12 months, including the time required after recruitment of the last subject for closing and editing the database, data analysis, and preparation of the final study report.
The total duration of the study for each participant will be 6 months from the date of inclusion.
Acceptance criteria
- A score of 8 or higher in the Clinical Utility Score (CUS) filled by the medical staff.
Inclusion and exclusion criteria
Inclusion criteria
- Patients who have provided their informed consent for participation in the study.
- Patients who demonstrate proficiency in both written and spoken Spanish or English.
- Patients who possess a smartphone, defined as a phone equipped with internet access and an integrated camera, regardless of make, model, or technical specifications.
Exclusion criteria
- Patients who, as determined by the investigator, did not adhere to the study procedures.
- Patients who were already utilizing the tool under investigation prior to the commencement of the study.
Variables
Main variable
- The score given by the clinicians in the Clinical Utility Questionnaire (CUS).
Secondary variables
- Demographic data: sex, age, zip code.
- Clinical data: diagnosis, date of diagnosis, medication the patient is taking.
- Worsening pathology alerts.
- Quality of life: score of the Dermatology Quality of Life Index or DLQI questionnaire.
- Degree of patient satisfaction using the patient satisfaction questionnaire.
- Consultation management indicators: number of face-to-face consultations, number of telematic consultations and consultation times.
- Evaluation of the usability of the device by clinicians and patients, using the System Usability - Scale (SUS) questionnaire (Annex III).
- Use of the application: logins, photographs sent.
Condition of interest
Patients with any of the following chronic dermatological pathologies: Psoriasis, Urticaria, Hidrosadenitis suppurativa, Acne, Atopic dermatitis, Vitiligo, Infantile hemangioma and Nail pathology.
Limitations of clinical research
The main limitation of machine learning lies in the quantity and quality of the images collected. Variability in illumination, color, shape, size and focus are determinants, in addition to the number of images per patient. This means that a large variability within the same patient and an insufficient number of images to reflect that variability may result in a lower accuracy than expected.
On the other hand, it is worth mentioning that the present study excludes from its objectives factors that would play a role in the validation of a new scale for measuring the activity of some chronic dermatological pathology from the device, such as the Minimal Detectable Change or the inclusion of new parameters, such as the exact number of lesions or the diameter of the largest lesion, and focuses on the diagnostic capability of the algorithm and the usability advantages of the tool.
However, it could be expected that a new data collection tool, such as automatic vision algorithms, will open the door to the creation of new measurement scales for some chronic dermatological pathology, whose use was not feasible in the absence of such a tool - either because of the automaticity of data collection, or because of the precision in the calculation of parameters such as the number of lesions, the affected surface or the redness.
Ethical considerations
The conduct of the study will conform to international Good Clinical Practice standards, to the Declaration of Helsinki in its latest active amendment, and to international and national rules and regulations and will not be initiated until approval has been obtained from the Vinalopó-Torrevieja Ethics Committee. Any modification of this protocol will be reviewed and approved by the Principal Investigator and must be evaluated by the Ethics Committee for approval before including subjects in a modified protocol.
The study will be conducted according to European Regulation 2016/679, of 27 April, on the protection of natural persons with regard to the processing of personal data and the free movement of such data and Organic Law 3/2018, of 5 December, on the Protection of Personal Data and guarantee of digital rights with regard to data processing in which no data that allows the personal identification of subjects will be included, the information being managed in an encrypted manner.
Patients will be informed orally and in writing about all the information related to the study and adapted to their level of understanding. A copy of the consent form and information sheet should be provided to the patient. The investigator should allow the patient the necessary time to ask questions about the details of the study.
Preparation of the informed consent form is the responsibility of the Principal Investigator. This form should include all the elements required by the International Conference of Harmonization (ICH), current regulatory guidelines, and comply with the Standards of Good Clinical Practice (GCP) and ethical principles that originate from the Declaration of Helsinki.
The investigator or the Principal Investigator's designee will keep the original signed informed consent form in a secure restricted access area under the custody of the Principal Investigator and will never leave the center and will give a copy of the original signed consent form to the patient.
Data confidentiality
Current legislation will be complied with in terms of data confidentiality protection (European Regulation 2016/679, of 27 April, on the protection of natural persons with regard to the processing of personal data and the free movement of such data and Organic Law 3/2018, of 5 December, on Personal Data Protection and guarantee of digital rights). For this purpose, each patient will receive an alphanumeric identification code in the study that will not include any data allowing personal identification (coded CRD). The Principal Investigator will have an independent list that will allow the connection of the identification codes of the patients participating in the study with their clinical and personal data. This document will be filed in a secure area with restricted access, under the custody of the Principal Investigator and will never leave the center.
Once the paper CRDs are completed and closed by the Principal Investigator, the data will be transferred to a database. As in the CRDs, the Database will comply with current legislation in terms of data confidentiality protection (European Regulation 2016/679, of 27 April, on the protection of natural persons with regard to the processing of personal data and the free movement of such data and Organic Law 3/2018, of 5 December, on the Protection of Personal Data and guarantee of digital rights) in which no data allowing personal identification of patients will be included.
Bias minimization measures
In clinical research, minimizing bias is essential to ensure the validity and reliability of the study's results. In this study, patients will be randomly selected to participate in this. Thus, outcomes will not be influence by pre-existing characteristics of the participants. Furthermore, we will use standarized protocols, Using standardized procedures for conducting the study and measuring outcomes ensures that all participants are treated and evaluated in the same way, reducing variability due to differences in how the intervention is applied or how outcomes are assessed. Finally, Collecting data prospectively reduces the chance that participants or investigators will inaccurately recall past events, which is common in retrospective studies.
Calendar
This study estimates a recruitment period of 6 months. The total duration of the study is estimated at 12 months, including the time required after recruitment of the last subject for closing and editing the database, data analysis, and preparation of the final study report. The total duration of the study for each participant will be 6 months from the date of inclusion.
Monitoring plan
The Legit.Health team will hold a meeting with the investigative team every 3 months to address any potential questions and ensure that data is being collected properly.
Completition of the investigation
After the final closure of the clinical investigation, a Clinical Investigation Report (CIR: T-015-006 Clinical Investigation Report) will be drafted, even in the event of early termination or suspension. The CIR will be provided to the Ethics Committee and the Spanish Agency for Medicines and Medical Devices (AEMPS). The results obtained (whether positive, inconclusive, or negative) will be included in the previously mentioned public access database.
Additionally, if deemed appropriate, the results may be published in scientific journals. The Ethics Committee that approved this clinical investigation will be acknowledged, and any funds received by the author for the study and its source of funding will be disclosed. The anonymity of participants in the clinical investigation will be maintained at all times.
Upon completion of the study, the results of the clinical utility and satisfaction surveys, as per the annexed models, may be presented at conferences and scientific meetings, subject to prior authorization by both parties. Press releases and other communications may also be issued to share the study's results. All publications and communications must be reviewed and approved by the parties involved.
Statistical analysis
Each variable will be characterized using frequency distributions for qualitative variables and central tendency statistics such as mean and median and variability statistics such as standard deviation (S.D.) or interquartile range for quantitative variables according to their distributional characteristics.
Between-group and within-group comparisons will be made using parametric tests whenever the distributional characteristics of the data allow it. For intergroup comparisons, one- and two-factor Analysis of Variance techniques will be used with post-hoc comparisons if significant overall differences are detected. To assess intra-group changes, Student's t-test for related samples or Analysis of Variance/ANOVA with repeated measures will be used if the theoretical assumptions of the model are supported by the data. Otherwise, more flexible models (GEE) that allow incorporating different autocorrelation structures of the data will be fitted.
Comparisons between groups with respect to qualitative variables will be carried out by means of contingency tables and Fisher's exact or Chi-square tests. The probability of type I error will not be adjusted for multiple comparisons. The level of statistical significance in the contrasts (alpha) will be 5 percent with bilateral contrasts.
Comparisons between two continuous variables will be made using Pearson's or Spearman's correlation, depending on the distributional characteristics. Sensitivity, specificity, positive and negative predictive values (PPV and NPV) and likelihood ratios (LR+ and LR-) will be calculated by comparing the results obtained using the Legit.Health tool and the paper questionnaire system used as the gold standard.
Analyses will be performed using appropriate statistical software, SPSS version 23.0 and STATA 13.0. Values of p less than 0.05 will be considered significant.
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 databases 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 Legit.Health) is the owner of the software named "Legit.Health Plus". During the period of validity of this study, Legit.Health will grant a license to use the Legit.Health Plus device to the research team free of charge. The research team will be the administrator of the account created on the Legit.Health platform. Both patients and members of the medical team will have login credentials. The Legit.Health team will not have access to the account or patient information.
The Data Controller is the research team. Legit.Health is the Data Processor and is not responsible for the processing of the data included in the Software or its users. The storage of data and photographs will be in line with the European Regulation 2016/679 of 27 April on the protection of natural persons with regard to the processing of personal data and the free movement of such data 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 Legit.Health platform complies with current legislation on the protection and confidentiality of personal data (European Regulation 2016/679 of 27 April on the protection of natural persons with regard to the processing of personal data and on the free movement of such data and Organic Law 3/2018 of 5 December on the Protection of Personal Data and guarantee of digital rights). 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 will be 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 favorable feedback and the corresponding approval have been obtained.
- In the case of substantial modifications to authorized clinical investigations, a request must be submitted to the AEMPS.
- 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 emergency situations (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.
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. Annual follow-up reports will be submitted thereafter.
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 in accordance with 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.
This clinical investigation will not commence until approval/favorable 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.
Informed Consent process
The patient, or in their absence, the family member or legally authorized representative, must provide written consent before their inclusion in the clinical investigation. This will occur after they have understood, through a prior interview with the principal investigator or a member of the research team, the objectives of the investigation, its risks, inconveniences, and benefits, as well as the conditions under which it will be conducted, and after being informed of their right to withdraw from the investigation at any time without explanation and without incurring any responsibility or prejudice.
The principal investigator will discuss the study with the subject and provide the information objectively, without coercion or influence, and without offering any inappropriate or undue incentive. The principal investigator will use non-technical language in the subject's native language (or that of the spouse/closest relative or legally authorized representative) for better understanding and will allow sufficient time for reading and comprehending the information.
Each participant will document their informed consent by signing and dating the informed consent form. Each signed and dated consent will be kept by the principal investigator, and a copy of the informed consent will be provided to the subject.
If new important information arises that could affect the subject's willingness to continue participating in the clinical investigation, it will be provided in any case. If necessary, their continued informed consent will be confirmed in writing.
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.
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 other 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.
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.
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.
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. Likewise, the sponsor or principal investigator will notify the IRB. 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 center.
If the clinical investigation is resumed, the sponsor must inform the principal investigator, the IRB 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.
Annexes
Annex I. Protocol of the study
Annex II. Ethics committee approval
Record signature meaning
- Author: JD-018 Jordi Barrachina
- Review: JD-003 Taig Mac Carthy
- Approval: JD-005 Alfonso Medela