R-TF-015-010 Annex E ISO 14155
ISO 14155:2020 Compliance Requirements
This section documents compliance with ISO 14155:2020 requirements for clinical investigations of medical devices. The table below provides a comprehensive checklist of documentation required under ISO 14155 and indicates which documents have been provided or prepared for this clinical investigation.
| Document Title | Purpose | Included | Justification if not provided |
|---|---|---|---|
| Investigator's Brochure | Provides clinical and non-clinical data on the investigational device relevant to its study in human subjects. | FALSE | An Investigator's Brochure is not required for this study. The research team was not responsible for administering or directly operating the device itself. Instead, investigators reviewed diagnostic information and outputs provided by the Legit.Health Plus system. All necessary technical information about the device, its algorithms, performance characteristics, and clinical validation data are documented in the Investigational Device Dossier and the training materials provided to investigators. Comprehensive training covering device functionality, proper interpretation of outputs, and data entry procedures was provided to all investigators and is documented in the training records. This approach is consistent with ISO 14155 requirements for observational studies where investigators are end-users of system outputs rather than device operators. |
| Clinical Investigation Plan (CIP) | Describes the rationale, objectives, design, methodology, monitoring, and conduct of the clinical investigation. | TRUE | |
| Subject Information Sheet and Informed Consent Form (ICF) | Ensures that potential study subjects are adequately informed about the investigation and provide voluntary consent. | FALSE | The requirement for a Subject Information Sheet and Informed Consent Form (ICF) is waived due to the retrospective, non-interventional nature of the research. The study involved the review of anonymized clinical images that had been previously collected as part of routine medical care, with no additional data collection, patient contact, or interventions taking place. No human subjects underwent any study-related procedures; therefore, individual informed consent for study participation was not required. |
| Ethics Committee Approval | Official approval from the ethics committee to conduct the clinical investigation. | FALSE | This study does not require Ethics Committee approval because it involves the retrospective and prospective analysis of fully anonymized clinical images sourced from public dermatology databases and atlases. All images are completely de-identified and contain no information permitting patient identification. The research did not involve the recruitment of patients, any form of intervention, clinical contact, or changes to standard clinical practice. As an observational study of public, anonymized data, the research qualifies for exemption from ethics committee review under applicable EU and Spanish regulatory frameworks (EU Regulation 2016/679 and Spanish Organic Law 3/2018). |
| Regulatory Authority Authorization | Authorization or notification from relevant regulatory bodies to proceed with the clinical investigation. | FALSE | This study did not require Regulatory Authority Authorization. As an observational, non-interventional study involving only the analysis of fully anonymized clinical images from public sources, with no patient recruitment, interventions, or changes to clinical care, the research meets criteria for exemption from regulatory authorization requirements under applicable Spanish legislation (including Law 1090/2015 on clinical trials). The study design demonstrates compliance with ISO 14155:2020 principles and MDR Annex XV provisions for observational clinical studies. |
| Case Report Forms (CRFs) | Documents designed to record all protocol-required information to be reported to the sponsor on each trial subject. | TRUE | In the present clinical investigation, the Case Report Form (CRF) was implemented through a secure web-based system designed for the standardized annotation of study images. Data generated through investigator annotations were systematically captured, securely stored, and are available for export in CSV file format. The complete dataset, containing the original investigator annotations, can be provided upon formal request to the Sponsor. Full traceability from source data to exported records is maintained in accordance with Good Clinical Practice (GCP) and applicable regulatory requirements. |
| Monitoring Plan | Describes the strategy, methods, responsibilities, and requirements for monitoring the clinical investigation. | TRUE | Detailed in the CIP |
| Subject Recruitment Materials | Materials used to recruit subjects, ensuring they are ethically and appropriately informed. | FALSE | This study is exempt from the requirement to provide Subject Recruitment Materials because it involves only the retrospective analysis of fully anonymized clinical images collected during routine medical care. No active recruitment, advertisement, or solicitation of participants was conducted for the purposes of this study. As there was no direct contact with subjects, and no new data collection from them was performed, recruitment materials were not necessary nor applicable. This approach is in alignment with ISO 14155 and relevant regulatory guidelines for retrospective, non-interventional studies. |
| Signed Agreements | Contracts between the sponsor, investigators, and institutions detailing roles and responsibilities. | TRUE | Accessible upon formal request addressed to the study sponsor. |
| Delegation of Duties Log | Documents identifying the study-related duties and responsibilities assigned to each team member. | TRUE | Detailed in the CIP |
| Training Records | Evidence of training provided to the investigation team on the CIP, investigational device, and GCP principles. | TRUE | Training sessions were conducted for all investigators and study staff involved in the clinical investigation. The content of the training included the study protocol, the correct use of the device, data entry procedures, and compliance with ISO 14155 and Good Clinical Practice (GCP) requirements. Attendance logs were maintained, and the training records are available in presentation format (slides) detailing the topics covered. These presentations, along with participant attendance records, are retained as part of the study's essential documents and can be provided for audit or inspection upon request. |
| Investigational Device Accountability Records | Tracks the receipt, use, and disposition of the investigational device to ensure traceability. | FALSE | Given the software nature of the medical device, access and utilization traceability was maintained through controlled system access. The research team was granted restricted access to the Legit.Health Plus annotation platform through individualized login credentials (username and password), ensuring that all system interactions and data entries could be linked to specific investigators. This access control methodology provides full audit trail capabilities and traceability comparable to physical device accountability records. System access logs and corresponding email communications confirming credential issuance are available upon request to support documentation requirements. |
| Subject Identification Code List | Confidential list linking subjects' codes to their identities, maintained by the investigator. | FALSE | A Subject Identification Code List is not applicable to this study because all clinical images analyzed were fully anonymized and de-identified prior to the study. The images were sourced from public dermatology databases and atlases, containing no direct or indirect identifiers that could permit patient identification. No subject recruitment or enrollment occurred; therefore, no subject code list was generated or maintained. All data processing was conducted in full compliance with EU Regulation 2016/679 (GDPR) Article 4(1) definition of anonymized data and Spanish Organic Law 3/2018 requirements for data protection. The irreversible anonymization of source images prior to analysis ensures that subject identification is technically and legally impossible. |
| Screening and Enrollment Logs | Documents tracking the screening and enrollment status of potential and actual study subjects. | FALSE | Screening and Enrollment Logs are not applicable to this study. The research constitutes a retrospective analysis of existing anonymized clinical images sourced from public databases and collections. No patient screening, recruitment, or enrollment procedures were conducted. No subjects were prospectively identified, screened, or enrolled for the study. The healthcare professional investigators evaluated images as part of the study protocol, but this does not constitute subject recruitment or enrollment in the traditional clinical trial sense. As an observational study of public, de-identified data, traditional screening and enrollment logs are neither required nor applicable under ISO 14155 principles for observational studies. |
| Investigational Device Dossier (IDD) | Comprehensive technical and clinical data on the investigational device, including design, manufacturing, and performance information. | TRUE | Available as a separate document detailing device specifications, technical performance, manufacturing quality systems, and clinical validation data. |
| Insurance Statement | Proof of insurance coverage for participants in case of study-related injuries. | FALSE | An insurance statement is not required for this study. The research involved only the retrospective analysis of fully anonymized clinical images collected from public sources and databases. The study was non-interventional—no direct patient contact, clinical procedures, therapeutic interventions, or investigational treatments were administered. Investigator participants (healthcare professionals) were not research subjects but rather contributors to data collection through image evaluation. No participant-related injuries or adverse events were possible given the purely observational nature of the study using existing images. |
| Financial Disclosure Records | Documentation of any financial interests of investigators that could affect the study's integrity. | TRUE | |
| Audit Certificates | Reports from independent audits assessing compliance with the CIP and GCP. | FALSE | No independent third-party audit has been conducted for this clinical investigation as of the completion date (September 15, 2024). However, an internal quality review was performed by the sponsor to verify protocol compliance and adherence to Good Clinical Practice principles during study conduct. Should future regulatory submissions or approvals require an independent audit, external audit services can be commissioned and completed to assess CIP compliance and GCP adherence. The study documentation is designed to support such future audit activities with complete traceability of study conduct, data integrity, and investigator activities throughout the research period. |
| Final Clinical Investigation Report | A comprehensive report summarizing the clinical investigation's methodology and results. | TRUE |
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