R-TF-015-010 Annex E ISO 14155
| 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, as the research is an observational, retrospective study based solely on the review of previously collected patient images. At no point did the study involve direct contact with patients, nor did it alter their clinical care or treatment plans. |
| 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. |
| 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 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. |
| 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 it involved only the retrospective analysis of fully anonymized clinical images originally collected during routine clinical care. According to applicable Spanish legislation, such observational and non-interventional studies are exempt from regulatory authorization requirements. Additionally, the study was designed in consideration of ISO 14155 principles and MDR Annex XV provisions. |
| 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, 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 | |
| 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, JD-004
- Approver: JD-005