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 study, the development of an Investigator's Brochure is not considered necessary. The research is a prospective observational study based on the review of completely anonymized images sourced from public dermatological atlases and freely available sources. At no point did the study involve direct contact with patients or recruitment of human subjects, nor did it alter clinical care or treatment plans. The images used were previously published materials with confirmed diagnoses, making an IB unnecessary. |
| 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 from patients is not applicable to this study. The research involved the review of completely anonymized images from public dermatological atlases and freely available sources, where individuals cannot be identified. There was no active patient recruitment, no direct patient contact, and no additional data collection from patients. The images constitute non-personal data under GDPR. For participating healthcare practitioners, while formal ICF was not required (as the study is observational and non-interventional with respect to their clinical practice), all practitioners signed a participation contract with the sponsor and received detailed written and oral information about the study. |
| Ethics Committee Approval | Official approval from the ethics committee to conduct the clinical investigation. | FALSE | This study does not require Ethics Committee approval. The research utilizes completely anonymized medical images sourced from public dermatological atlases and openly accessible public sources where individuals cannot be identified. These images are not derived from identifiable patients, and the study design ensures that patient recognition is impossible. As these images constitute non-personal data under GDPR (Regulation 2016/679) and Spanish Organic Law 3/2018, they do not fall under the scope of human subjects research requiring ethics committee review. Additionally, the study involves no patient recruitment, no direct patient contact, no interventions, and no modifications to standard clinical care. Under applicable Spanish legislation (Organic Law 1090/2015) and GDPR guidance, such research based entirely on fully anonymized, publicly available data does not require ethics committee authorization. |
| 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. The research is based exclusively on completely anonymized images from public dermatological atlases and freely available sources, where individuals cannot be identified. The study involved no patient recruitment, direct patient contact, or interventions. Under applicable Spanish legislation (Organic Law 1090/2015) and EU MDR 2017/745 guidance, observational studies based entirely on fully anonymized, publicly available data from non-identifiable sources are not subject to regulatory authority authorization requirements. Additionally, the study was designed in consideration of ISO 14155:2020 principles and follows best practices for non-interventional research. |
| 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 14155:2020 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 formal request to the sponsor, if deemed necessary. |
| 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, the research team was granted controlled access to the Legit.Health annotation platform through individualized login credentials (username and password). This method ensured proper access and traceability of all annotation activities. If required, the corresponding email communications confirming access provision can be shared to further support documentation and traceability. |
| Subject Identification Code List | Confidential list linking subjects' codes to their identities, maintained by the investigator. | FALSE | This study involves the retrospective analysis of fully anonymized clinical images that were originally collected during routine medical care. The research did not involve the recruitment of patients, any form of intervention, or changes to standard clinical practice. |
| Screening and Enrollment Logs | Documents tracking the screening and enrollment status of potential and actual study subjects. | FALSE | This study involves the retrospective analysis of fully anonymized clinical images that were originally collected during routine medical care. The research did not involve the recruitment of patients, any form of intervention, or changes to standard clinical practice. |
| 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 images collected during routine medical care. 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 | Financial disclosure and declaration of interests forms have been completed by all investigators involved in this clinical investigation. These documents provide documentation of any financial relationships or interests that could potentially affect their objectivity or the integrity of the research findings. The records are maintained as part of the study's essential documents and are available upon formal request. |
| Audit Certificates | Reports from independent audits assessing compliance with the CIP and GCP. | FALSE | An independent external audit was not conducted for this study. However, the study design, data collection processes, and compliance with the CIP and GCP requirements were assessed and verified internally by the sponsor. Given the straightforward, non-interventional nature of the research (review of anonymized images by trained practitioners on a secure platform), an internal assessment was determined to be sufficient for regulatory purposes. Records of the internal assessment and verification activities are available upon formal request. |
| 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