R-TF-015-010 Annex E ISO 14155
Applicability and scope
This annex documents compliance of the clinical investigation COVIDX_EVCDAO_2022 with the documentation requirements of UNE-EN ISO 14155:2021. The investigation is a prospective, observational, single-arm clinical investigation on real adult patients attending a hospital dermatology department; under MDCG 2020-6 Appendix III it constitutes Rank 2–4 evidence; under MDCG 2020-1 §4.4 it contributes Pillar 3 Clinical Performance supporting evidence for the clinical-utility, data-utility, usability and patient-satisfaction aspects of the clinician+device remote-monitoring workflow. The device under investigation corresponds to the current CE-marked release v1.1.0.0 (identity bridge documented in the Clinical Investigation Plan and Clinical Investigation Report).
The investigation was conducted as a non-interventional clinical investigation of a CE-marked medical device used within its intended purpose. It was conducted under prior favourable opinion of the competent Ethics Committee for Research with Medicinal Products and in accordance with applicable Spanish biomedical-research legislation, Regulation (EU) 2016/679 (GDPR) and the Spanish Organic Law 3/2018 on the Protection of Personal Data and Guarantee of Digital Rights.
UNE-EN ISO 14155:2021 compliance requirements
The table below documents the documentation elements required under UNE-EN ISO 14155:2021, and for each element indicates whether it is included and — where an element is marked as not included — the regulatory-level justification or the location of the retained record.
| Document Title | Purpose | Included | Location or justification |
|---|---|---|---|
| Investigator's Brochure | Provides clinical and non-clinical data on the investigational device relevant to its use in human subjects. | TRUE | The Instructions for Use v1.1.0.0 of the CE-marked device, together with the Device Description and Specifications record held within the technical file, served as the investigator orientation document for this investigation. |
| Clinical Investigation Plan (CIP) | Describes the rationale, objectives, design, methodology, monitoring and conduct of the clinical investigation. | TRUE | R-TF-015-004 Clinical Investigation Plan. |
| Subject Information Sheet and Informed Consent Form (ICF) | Ensures that potential study subjects are adequately informed about the investigation and provide voluntary consent. | TRUE | Patient Information Sheet and Informed Consent Form retained at the investigational site under the custody of the Principal Investigator; Annexes III and IV of the CIP reproduce the approved versions. |
| Ethics Committee Approval | Official approval from the Ethics Committee to conduct the clinical investigation. | TRUE | Favourable opinion dated 2022-04-13, reference number 12/04/22 LEGIT_COVIDX, issued by the Comité de Ética de la Investigación con Medicamentos de los Hospitales Universitarios Torrevieja y Elche-Vinalopó; retained in Annex II of the CIP. |
| Regulatory Authority Authorization | Authorisation or notification from relevant regulatory bodies to proceed with the clinical investigation. | FALSE | Non-interventional observational clinical investigation of a CE-marked medical device used within its intended purpose; under the Spanish biomedical-research framework applicable at the time of conduct, the investigation is subject to a favourable opinion of the competent Ethics Committee (obtained) but does not trigger a pre-market clinical-investigation authorisation under MDR Article 62. |
| Case Report Forms (CRFs) | Documents designed to record all protocol-required information to be reported to the sponsor on each trial subject. | TRUE | Electronic case-report form implemented in the device's secure, access-controlled web-based component; CRF version, data dictionary and source-data-verification method are described in the CIP §Data management and retained within the sponsor's trial master file. |
| Statistical Analysis Plan | Describes the pre-specified statistical methods, analysis populations, primary and secondary endpoints, and decision rules. | TRUE | Pre-specified in CIP §Statistical analysis; applied as reported in CIR §Analysis. |
| Monitoring Plan | Describes the strategy, methods, responsibilities and requirements for monitoring the clinical investigation. | TRUE | CIP §Monitoring plan; monitoring activities retained in the sponsor's trial master file. |
| Subject Recruitment Materials | Materials used to recruit subjects, ensuring they are ethically and appropriately informed. | TRUE | Patient Information Sheet (Annex III of the CIP) served as the recruitment material; the Ethics Committee favourable opinion covers the version approved at study initiation. |
| Signed Agreements | Contracts between the sponsor, investigators and institutions detailing roles and responsibilities. | TRUE | Signed agreements retained under sponsor custody and referenced in the sponsor's trial master file. |
| Delegation of Duties Log | Documents identifying the study-related duties and responsibilities assigned to each team member. | TRUE | Delegation-of-duties log retained at the investigational site under the custody of the Principal Investigator; the delegated roles are enumerated in CIP §CIP or protocol specifications and in CIR §Research Team. |
| Training Records | Evidence of training provided to the investigation team on the CIP, investigational device and GCP principles. | TRUE | Initiation-visit training records retained at the investigational site under the custody of the Principal Investigator; training materials retained under the sponsor's training-record procedure. |
| Investigational Device Accountability Records | Tracks the receipt, use and disposition of the investigational device to ensure traceability. | TRUE | Version provisioning and session logging were controlled by the manufacturer under the QMS; the device version under investigation corresponds to the current CE-marked release v1.1.0.0 (identity bridge, PRRC-signed, CIP §Device version under investigation and bridging to the CE-marked release). Individual authenticated user accounts were provisioned to each investigator and each subject; session logs were retained under the sponsor's information-security and records-retention procedures. |
| Subject Identification Code List | Confidential list linking subjects' codes to their identities, maintained by the investigator. | TRUE | Subject identification code list retained confidentially at the investigational site under the custody of the Principal Investigator; un-pseudonymised mapping not released outside the investigational site except as required by applicable regulatory audit. |
| Screening and Enrollment Logs | Documents tracking the screening and enrolment status of potential and actual study subjects. | TRUE | Screening and enrolment log retained confidentially at the investigational site under the custody of the Principal Investigator; cohort accountability (400 screened, 240 excluded at screening, 160 enrolled) is reported in CIR §Subject disposition and accountability. |
| Deviations Log | Documents protocol deviations identified during the investigation, with assessment of impact and actions taken. | TRUE | Documented in CIR §Deviations from the Clinical Investigation Plan. |
| Adverse-event reporting procedure | Describes the mechanism for identifying, recording and reporting adverse events and adverse device effects during the investigation. | TRUE | AE-collection mechanism described in CIR §Adverse events and adverse reactions to the product; no AEs, adverse reactions or serious adverse events related to the investigational product were reported during the investigation window. |
| Device-deficiency reporting procedure | Describes the mechanism for identifying, recording and reporting device deficiencies during the investigation. | TRUE | Device-deficiency reporting mechanism described in GP-009 Post-Market Surveillance and in the CIP; no device deficiencies that could have led to a serious adverse event or adverse device effect were reported during the investigation. |
| Annual safety and progress report to the Ethics Committee | Periodic report to the Ethics Committee on the progress and safety of the investigation. | TRUE | The Ethics Committee was kept informed of the investigation's progress and of the timeline extension during the recruitment period; retained under sponsor custody. |
| Investigational Device Dossier (IDD) | Comprehensive technical and clinical data on the investigational device, including design, manufacturing and performance information. | FALSE | The device is CE-marked and its technical file is maintained under the MDR Annex II and Annex III structure of the QMS (R-TF-012 design-and-development series, R-TF-013-002 Risk Management Record, verification-and-validation records, cybersecurity documentation and the Instructions for Use v1.1.0.0). These records, taken together, serve the IDD purpose for this investigation. |
| Insurance Statement | Proof of insurance coverage for participants in case of study-related injuries. | FALSE | The investigation is a non-interventional observational clinical investigation of a CE-marked medical device used within its intended purpose; participants continued to receive standard of care and no investigational intervention was performed. Under the Spanish biomedical-research framework applicable at the time of conduct, a specific clinical-trial insurance instrument was not required. |
| Financial Disclosure Records | Documentation of any financial interests of investigators that could affect the integrity of the investigation. | TRUE | Financial-disclosure records retained under sponsor custody. |
| Audit Certificates | Reports from independent audits assessing compliance with the CIP and GCP. | FALSE | No independent compliance audit was commissioned for this investigation; internal monitoring was conducted in accordance with the Monitoring Plan and retained under sponsor custody. |
| Final Clinical Investigation Report | Comprehensive report summarising the clinical investigation's methodology and results. | TRUE | R-TF-015-006 Clinical Investigation Report. |
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-018 Clinical Research Coordinator
- Approver: JD-022 Medical Manager