R-TF-015-006 Clinical investigation report_LEGIT_MX_EVCDAO_2020
Research Title
Research Description
If it is not clearly evident from the title itself, provide a single sentence describing the study design, comparison, duration, method of use, and the subject population.
Product Identification
Promoter Identification and Contact
CIP Identification
Public Access Database
Research Team
Compliance Statement
This clinical research has been conducted in accordance with the harmonized standard UNE-EN ISO 14155:2021 and European Regulation MDR 2017/745.
Report Date
Report author(s)
The full name, the ID and the signature for the authorship, as well as the approval process of this document, can be found in the verified commits at the repository. This information is saved alongside the digital signature, to ensure the integrity of the document.
Table of contents
Table of contents
- Research Title
- Research Description
- Product Identification
- Promoter Identification and Contact
- CIP Identification
- Public Access Database
- Research Team
- Compliance Statement
- Report Date
- Report author(s)
- Table of contents
- Abbreviations and Definitions
- Summary
- Introduction
- Materials and methods
- Results
- Discussion and Overall Conclusions
- Ethical Aspects of Clinical Research
- Investigators and Administrative Structure of Clinical Research
- Signature Page
- Report Annexes
Abbreviations and Definitions
Summary
Title
Introduction
Objectives
Population
Design and Methods
Design
Number of Subjects
Initiation Date
Completion Date
Duration
Methods
Results
Conclusions
Introduction
The introduction should contain a brief statement framing the clinical research in the context of product development under investigation and linking critical aspects of clinical research (e.g., objectives and hypotheses, target population, treatment, and follow-up duration) with such development. Any guidelines followed in CIP (Clinical Investigation Plan) development or any other agreements/meetings between the promoter and regulatory authorities relevant to the specific clinical research should be identified or described.
Materials and methods
Product Description
Product Description
Intended Purpose of the Product
Intended Previous Uses
Product Changes During Clinical Research
Clinical Research Plan
Provide a summary of the CIP (Clinical Investigation Plan), including any subsequent modifications with justification for each modification. The summary should include a brief description of the points indicated below.
Objectives
Design (type of research, assessment criteria, methods, active group, and control group)
Ethical Considerations
This study adhered to international Good Clinical Practice (GCP) guidelines, the Declaration of Helsinki in its latest amendment, and applicable international and national regulations. As applicable, approval from the relevant Ethics Committee was obtained prior to the initiation of the study. When applicable, modifications to the protocol were reviewed and approved by the Principal Investigator (PI) and subsequently evaluated by the Ethics Committee before subjects were enrolled under a modified protocol.
This study was conducted in compliance with European Regulation 2016/679, of 27 April, concerning the protection of natural persons with regard to the processing of personal data and the free movement of such data (General Data Protection Regulation, GDPR), and Organic Law 3/2018, of 5 December, on the Protection of Personal Data and the guarantee of digital rights. In accordance with these regulations, no data enabling the personal identification of participants was collected, and all information was managed securely in an encrypted format.
Participants were informed both orally and in writing about all relevant aspects of the study, with the information being tailored to their level of understanding. They were provided with a copy of the informed consent form and the accompanying patient information sheet. Adequate time was given to patients to ask questions and fully comprehend the details of the study before providing their consent.
The PI was responsible for the preparation of the informed consent form, ensuring it included all elements required by the International Conference on Harmonisation (ICH), adhered to current regulatory guidelines, and complied with the ethical principles of GCP and the Declaration of Helsinki.
The original signed informed consent forms were securely stored in a restricted access area under the custody of the PI. These documents remained at the research site at all times. Participants were provided with a copy of their signed consent form for their records.
Data confidentiality
Current legislation will be complied with in terms of data confidentiality protection (European Regulation 2016/679, of 27 April, on the protection of natural persons with regard to the processing of personal data and the free movement of such data and Organic Law 3/2018, of 5 December, on Personal Data Protection and guarantee of digital rights). For this purpose, when applicable, each participant will receive an alphanumeric identification code in the study that will not include any data allowing personal identification (coded CRD). The Principal Investigator will have an independent list that will allow the connection of the identification codes of the patients participating in the study with their clinical and personal data. This document will be filed in a secure area with restricted access, under the custody of the Principal Investigator and will never leave the centre.
Once the paper CRDs are completed and closed by the Principal Investigator, the data will be transferred to a database.
As in the CRDs, the Database will comply with current legislation in terms of data confidentiality protection (European Regulation 2016/679, of 27 April, on the protection of natural persons about the processing of personal data and the free movement of such data and Organic Law 3/2018, of 5 December, on the Protection of Personal Data and guarantee of digital rights) in which no data allowing personal identification of patients will be included.
Data Quality Assurance
The Principal Investigator is responsible for reviewing and approving the protocol, signing the Principal Investigator commitment, guaranteeing that the persons involved in the centre will respect the confidentiality of patient information and protect personal data, and reviewing and approving the final study report together with the sponsor. All the clinical members of the research team assess the eligibility of the patients in the study, inform and request written informed consent, collect the source data of the study in the clinical record and transfer them to the Data Collection Notebook (DCN) or Data Collection Forms (CRF).
Subject Population (inclusion/exclusion criteria and sample size)
Treatment
Concomitant Medication/Treatment
Follow-Up Duration
Statistical Analysis
Include hypotheses or success/failure criteria, sample size calculation, statistical analysis methods, and interim analyses, where applicable.
Results
Initiation and Completion Date
The initiation date of the clinical research and the completion/suspension date of the clinical research.
Subject and Investigational Product Management
Management of subjects (number screened, randomized, and received therapy) and disposition of investigational products.
Subject Demographics
CIP (Clinical Investigation Plan) Compliance
Analysis
There should be a clear distinction between primary analyses, other pre-specified analyses, and additional analyses.
Clinical Performance, Efficacy, and Safety
An analysis of performance and results based on the evaluation criteria specified in the CIP (Clinical Investigation Plan).
Adverse Events and Adverse Reactions to the Product
A summary of all adverse events and adverse reactions to the product, including a discussion of the significance and severity of the event, necessary treatment, resolution, and the competent principal investigator's opinion on the causal relationship with the investigational products or procedures.
Product Deficiencies
A table summarizing all observed product deficiencies that could have caused a serious adverse reaction to the product and any corrective actions taken during the clinical research.
Subgroup Analysis for Special Populations
Any subgroup analysis required for special populations (e.g., sex, racial/cultural/ethnic subgroups), as applicable.
Accounting for All Subjects
Description of how missing data or deviations in the analysis were handled, including subjects who did not pass screening, were lost to follow-up, withdrew, or had their participation terminated prematurely and the reasons for such.
Discussion and Overall Conclusions
Clinical Performance, Efficacy, and Safety
Results of safety and performance and any other assessment criteria.
Clinical Risks and Benefits
Clinical Relevance
A discussion of the clinical relevance and importance of the results in light of other existing data and the state of the art.
Specific Benefit or Special Precaution
Implications for Future Research
Limitations of Clinical Research
Any limitations of clinical research (subject selection, retention, and compliance; investigator and user selection, retention, and compliance; bias introduced by lack of data, confounding factors, etc.).
Ethical Aspects of Clinical Research
This section should include:
- Confirmation that the EC reviewed the CIP (Clinical Investigation Plan) and any amendments (if required).
- Enumeration of all consulted ECs.
- Confirmation that the research was conducted in accordance with the ethical principles of the Helsinki Declaration.
- A statement that informed consent was obtained and when it was obtained.
Investigators and Administrative Structure of Clinical Research
Brief Description
Investigators
A list of investigators, including their institutional affiliation.
External Organization
The names and addresses of any third parties (such as central laboratories, CROs, consultants, and other contractors) who contributed to clinical research.
Promoter and Monitor
Signature Page
Signatures of the promoter and the coordinating investigator(s) indicating their agreement with the content of the clinical research report. If no coordinating investigator has been appointed, the signatures of the principal investigators should be obtained. Signature pages can be included separately from the clinical research report itself.
Report Annexes
Annexes to the report may contain the following information:
- The CIP, including amendments.
- Instructions for use.
- A list of principal investigators and the research centers to which they are affiliated, including a summary of their qualifications or a copy of their CVs.
- A list of collaborating investigators and the research centers to which they are affiliated, including a summary of their qualifications or a copy of their CVs.
- A list of the names and addresses of any third parties (such as central laboratories, CROs, consultants, and other contractors) who contributed to clinical research.
- A list of monitors.
- A list of ECs.
- Tabulation of all relevant datasets, including:
- Deviations from the CIP that affected subject rights, safety, or welfare, or the scientific integrity of clinical research.
- All adverse events, adverse reactions to the product, and product deficiencies.
- Withdrawals and suspensions.
- The audit certificate, if applicable.
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