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. This is a prospective observational study involving the review and annotation of anonymized dermatological images from public sources and atlases. The research did not involve patient recruitment, direct contact with patients, or alterations to clinical care or treatment plans. The device's clinical and non-clinical data are documented in the Investigational Device Dossier and regulatory submissions, making a separate Investigator's Brochure redundant for this investigation. |
| 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 non-interventional nature of the research and the use of anonymized data. The study involved the review and annotation of fully anonymized dermatological images sourced from public atlases and databases, with no patient recruitment, patient contact, or interventions taking place. Healthcare professionals participating in the study received oral information and signed participation contracts. As per Spanish legislation and GDPR requirements, no patient consent is required for the use of anonymized, non-identifiable images from public sources. |
| Ethics Committee Approval | Official approval from the ethics committee to conduct the clinical investigation. | FALSE | This prospective observational study does not require Ethics Committee approval. The research involved the annotation of fully anonymized dermatological images sourced from public atlases and freely available databases, not identifiable patient data. No patient recruitment, intervention, or alterations to standard clinical practice occurred. The study design, use of anonymized images from public sources, and healthcare professional participation approach (participation contracts only) align with Spanish legislation (Organic Law 3/2018 on Data Protection) and GDPR provisions exempting such studies from ethics committee oversight. |
| Regulatory Authority Authorization | Authorization or notification from relevant regulatory bodies to proceed with the clinical investigation. | FALSE | This prospective observational study did not require Regulatory Authority Authorization. The study involved the annotation of fully anonymized dermatological images from public sources, with no patient recruitment or intervention. Under applicable Spanish legislation (Organic Law 1090/2015 and Organic Law 3/2018) and GDPR, observational studies using anonymized, non-identifiable data from public sources are exempt from regulatory authorization. The study was designed in alignment with ISO 14155:2021 principles and complies with MDR Annex XV provisions 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 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 the prospective observational review and annotation of fully anonymized dermatological images. No active recruitment, advertisement, or solicitation of potential subjects (image annotators) was conducted for the purposes of this study, as healthcare professionals were directly invited to participate. As there was no general subject recruitment campaign, recruitment materials were not necessary. Healthcare professionals instead received oral information about the study and signed participation contracts. This approach is in alignment with ISO 14155:2021 and relevant regulatory guidelines for observational 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, 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 prospective observational study did not involve patient recruitment or the use of identifiable patient images. The research used fully anonymized dermatological images sourced from public atlases and databases. No patient identification, linkage codes, or identification lists were necessary or created. The healthcare professionals participating as image annotators provided their informed consent through participation contracts, and no subject identification code lists were required. |
| Screening and Enrollment Logs | Documents tracking the screening and enrollment status of potential and actual study subjects. | FALSE | This prospective observational study did not require formal screening and enrollment logs for subjects. Instead of recruiting patients for the study, the research involved inviting healthcare professionals (dermatologists and primary care practitioners) to participate in annotating dermatological images. These healthcare professionals were directly invited and signed participation contracts, without formal screening procedures. Enrollment records of participating healthcare professionals are maintained and available upon request. Consequently, traditional subject screening and enrollment logs were not applicable to this study design. |
| 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 | Insurance coverage was not required for this prospective observational study. The research involved only the review and annotation of anonymized dermatological images on a secure web-based platform. No procedures, interventions, or direct patient contact occurred that would create risk of injury to any study participants. Healthcare professionals participated voluntarily with informed understanding of the study's observational and non-interventional nature through participation contracts. Therefore, liability insurance specific to study-related injuries was not applicable. |
| Financial Disclosure Records | Documentation of any financial interests of investigators that could affect the study's integrity. | TRUE | Financial disclosure forms were collected from all investigators and study personnel involved in the clinical investigation. These forms document any potential financial interests, conflicts of interest, or relationships that could affect the study's integrity or objectivity. The disclosures are maintained as essential study documents and are available upon formal request. |
| Audit Certificates | Reports from independent audits assessing compliance with the CIP and GCP. | FALSE | An external independent audit was not deemed necessary for this study. Instead, an internal audit and comprehensive monitoring program was conducted by the sponsor to assess compliance with the Clinical Investigation Plan (CIP) and Good Clinical Practice (GCP) requirements. This internal audit included regular monitoring visits every three months, Source Data Verification (SDV), platform access audit trails, and documentation review. Given the straightforward observational design, limited duration, focused team, and robust internal monitoring mechanisms in place, an external audit was not required. All audit findings and monitoring reports are maintained as part of the study's essential documents. |
| 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, JD-004
- Approver: JD-005