R-TF-015-004 Clinical investigation plan
Scope
This clinical Investigation Plan (CIP) sets out the rationale, objectives, design, methodology, conduct, implementation, record-keeping, and method of analysis for the clinical investigation.
CIP Identification
CIP | |
---|---|
Title of the clinical investigation | Pilot study for the clinical validation of an artificial intelligence algorithm to optimize the appropriateness of dermatology referrals |
Device under investigation | Legit.Health |
Protocol version | Version 1.0 |
Date | 2022-04-07 |
Protocol code | LEGIT.HEALTH_DAO_Derivación_O_2022 |
Sponsor | AI Labs Group S.L. |
Coordinating Investigator | Dr. Jesús Gardeazabals and Dr. Rosa Mª Izu |
Principal Investigator(s) | Dr. Jesús Gardeazabals and Dr. Rosa Mª Izu |
Investigational site(s) | Health Center Sodupe-Güeñes, Health Center Balmaseda, Health Center Buruaga, and Health Center Zurbaran |
Ethics Committee | Comité de Ética de la Investigación con Medicamentos de Euskadi |
Table of contents
- Scope
- CIP Identification
- Compliance Statement
- Abbreviations and definitions
- CIP or protocol specifications
- Product Identification and Description
- Justification of the design
- Hypothesis
- Objectives
- Summary of the study
- Design and methods
- Condition of interest
- Ethical considerations
- CIP Modification
- CIP Deviations
- Start, follow-up and end reports
- Statements of compliance
- Informed Consent process
- Adverse events, adverse product reactions and product deficiencies
- Annexes
Compliance Statement
- Harmonized standard UNE-EN ISO 14155:2021.
- Regulation (EU) 2017/745 on medical devices (MDR).
- Harmonized standard UNE-EN ISO 13485:2016s.
- Regulation (EU) 2016/679 (GDPR).
- Spanish Organic Law 3/2018 on the Protection of Personal Data and guarantee of digital rights.
- Spanish Organic Law 1090/2015 on regulating clinical trials with medicines, the Ethics Committees for Research with Medicines and the Spanish Registry of Clinical Studies.