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 | In this retrospective observational study, an Investigator's Brochure is not required. The research involves analysis of previously collected anonymized clinical data and images without direct subject involvement or new interventions. The study does not involve investigation of the device in human subjects but rather retrospective assessment of algorithm performance using existing datasets. The technical specifications and performance data of AIHS4 are documented in the device's technical file and risk management record. |
| 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 | Informed consent collection is waived for this retrospective, non-interventional observational study because the research involved only analysis of fully anonymized clinical data that were previously collected in the M-27134-01 trial. Subjects enrolled in the original trial provided informed consent that explicitly authorized future use of their anonymized data in research investigations related to HS assessment. No new patient contact, procedures, or interventions occurred in this study; therefore, obtaining new informed consent would be neither feasible nor ethically necessary. The original informed consent encompasses the present analysis under its scope of authorization for future research use of anonymized data. |
| Ethics Committee Approval | Official approval from the ethics committee to conduct the clinical investigation. | FALSE | Prospective ethics committee approval is not required for this study because it involves retrospective analysis of fully anonymized clinical data that were irreversibly de-identified and originally collected during the M-27134-01 clinical trial. Under GDPR Article 4(1) and Spanish data protection legislation, truly anonymized data that cannot be linked to identifiable individuals fall outside the scope of data protection regulations and do not constitute research involving human subjects requiring ethics approval. The original M-27134-01 trial obtained appropriate ethics committee approval for the initial data collection. This retrospective analysis does not introduce any new ethical concerns or risks to subjects since no personal data processing occurs. |
| Regulatory Authority Authorization | Authorization or notification from relevant regulatory bodies to proceed with the clinical investigation. | FALSE | This retrospective observational study does not require prospective Regulatory Authority authorization. Under Spanish legislation and EU regulations, observational studies that involve analysis of previously collected anonymized data are exempt from regulatory authorization requirements. The data analyzed were originally collected under the M-27134-01 clinical trial framework which would have obtained appropriate regulatory approvals. This current analysis represents retrospective evaluation of existing anonymized datasets and is not subject to the same regulatory authorization requirements as prospective clinical investigations involving human subjects. The study design adheres to ISO 14155:2021 principles and is compliant with MDR Annex XV requirements for clinical evidence generation. |
| 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 collection of anonymized images and HS severity scores. 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 and severity scores of the algorithm, 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 | Subject recruitment materials are not applicable to this retrospective observational study. No active recruitment or enrollment of study participants was conducted; the study involved secondary analysis of previously collected anonymized data from the M-27134-01 clinical trial. Subjects from the original trial were recruited under that study's recruitment framework and provided informed consent. The current retrospective analysis does not involve recruitment of new subjects or direct contact with trial participants. Therefore, development of recruitment materials for this study was neither necessary nor relevant. |
| 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 | Investigational device accountability records in the traditional sense are not applicable because Legit.Health Plus is a software medical device. Access and usage were managed through individualized login credentials (username and password) assigned to authorized team members, ensuring proper access control and auditability. This electronic access management system provides traceability equivalent to physical device accountability records. Email communications documenting access provisioning and system usage logs provide an auditable trail of device interactions. This approach maintains appropriate documentation of device access and use in compliance with regulatory requirements for software medical devices. |
| Subject Identification Code List | Confidential list linking subjects' codes to their identities, maintained by the investigator. | FALSE | A subject identification code list is not required for this study because the analysis involved fully anonymized and irreversibly de-identified clinical data from the M-27134-01 trial. Patient identifiers were permanently removed prior to data transfer, making it technically impossible to re-identify subjects through any reasonable means. The data controller has confirmed that de-identification is complete and irreversible. Under GDPR Article 4(1), such truly anonymized data are not considered personal data and therefore do not require maintenance of identification code lists or other linking mechanisms. |
| 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 because this retrospective observational study did not involve prospective recruitment or enrollment of new study participants. The study analyzed previously collected data from subjects already enrolled in the M-27134-01 trial. No screening procedures, enrollment decisions, or participant recruitment occurred during this study phase. Such documentation would only be relevant for prospective studies involving active subject recruitment and enrollment processes. |
| Investigational Device Dossier (IDD) | Comprehensive technical and clinical data on the investigational device, including design, manufacturing, and performance information. | TRUE | Training records in this case served the same purpose. |
| Insurance Statement | Proof of insurance coverage for participants in case of study-related injuries. | FALSE | It was not required for this study, as it involved only the retrospective analysis of fully anonymized clinical data collected during the course of the clinical trial. No interventions, procedures, or actions involving risk to participants were performed. |
| 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 audit has been carried out for CIP and GCP compliance |
| 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