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. | TRUE | |
| 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. | TRUE | |
| Ethics Committee Approval | Official approval from the ethics committee to conduct the clinical investigation. | TRUE | |
| Regulatory Authority Authorization | Authorization or notification from relevant regulatory bodies to proceed with the clinical investigation. | FALSE | No Competent Authority (CA) approval was required under Spanish law for these types of observational, non-interventional studies. ISO 14155 and MDR Annex XV compliance were considered in study design |
| Case Report Forms (CRFs) | Documents designed to record all protocol-required information to be reported to the sponsor on each trial subject. | TRUE | |
| Monitoring Plan | Describes the strategy, methods, responsibilities, and requirements for monitoring the clinical investigation. | TRUE | Described in the CIP |
| Subject Recruitment Materials | Materials used to recruit subjects, ensuring they are ethically and appropriately informed. | FALSE | ICF serving the same purpose |
| Signed Agreements | Contracts between the sponsor, investigators, and institutions detailing roles and responsibilities. | TRUE | |
| Delegation of Duties Log | Documents identifying the study-related duties and responsibilities assigned to each team member. | TRUE | Described in the CIP |
| Training Records | Evidence of training provided to the investigation team on the CIP, investigational device, and GCP principles. | TRUE | The study initiation visit was conducted to familiarize the investigators with the CIP and the medical device. Specific training materials were prepared for this session and can be made available upon formal 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 medical device app 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 | Kept confidentially in each study centre |
| Screening and Enrollment Logs | Documents tracking the screening and enrollment status of potential and actual study subjects. | FALSE | Kept confidentially in each study centre |
| Investigational Device Dossier (IDD) | Comprehensive technical and clinical data on the investigational device, including design, manufacturing, and performance information. | FALSE | IB serving the same purpose |
| Insurance Statement | Proof of insurance coverage for participants in case of study-related injuries. | FALSE | In accordance with Article 2(2) of the MDR and the provisions of ISO 14155:2020, it is confirmed that this clinical investigation is non-interventional in nature and, therefore, does not require specific insurance coverage for study participants. Documentation supporting this rationale, including the Clinical Investigation Plan and ethical committee approvals, is available upon request. |
| 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