Clinical Investigation Report (CSR)
Dr Klinisch research provide a Comprehensive and End to End Clinical Trial Management Services for Medical Devices Industry, which included Clinical Investigation of medical device.
Clinical Investigation Report is prepared as per EU Medical Device Regulation 2017/745 of Annex XV requirements and ISO 14155:2020- Clinical investigation of medical devices for human subjects — Good clinical practice.
Each step in the clinical investigation, from the initial consideration of the need for and justification of the study to the publication of the results, shall be carried out in accordance with recognised ethical principles.
Methods:
Clinical investigations shall be performed on the basis of an appropriate plan of investigation reflecting the latest scientific and technical knowledge and defined in such a way as to confirm or refute the manufacturer’s claims regarding the safety, performance and aspects relating to benefit-risk of devices as referred to in Article 62(1) of MDR; the clinical investigations shall include an adequate number of observations to guarantee the scientific validity of the conclusions
The procedures used to perform the clinical investigation shall be appropriate to the device under investigation
The research methodologies used to perform the clinical investigation shall be appropriate to the device under investigation
Clinical investigations shall be performed in accordance with the clinical investigation plan by a sufficient number of intended users and in a clinical environment that is representative of the intended normal conditions of use of the device in the target patient population
All the appropriate technical and functional features of the device, in particular those involving safety and performance, and their expected clinical outcomes shall be appropriately addressed in the investigational design. A list of the technical and functional features of the device and the related expected clinical outcomes shall be provided
The endpoints of the clinical investigation shall address the intended purpose, clinical benefits, performance and safety of the device. The endpoints shall be determined and assessed using scientifically valid methodologies. The primary endpoint shall be appropriate to the device and clinically relevant
Investigators shall have access to the technical and clinical data regarding the device. Personnel involved in the conduct of an investigation shall be adequately instructed and trained in the proper use of the investigational device, and as regards the clinical investigation plan and good clinical practice.
The clinical investigation report, signed by the investigator, shall contain a critical evaluation of all the data collected during the clinical investigation, and shall include any negative findings
Documentation regarding the application for Clinical Investigation:
Application Form
Investigator’s Brochure
Clinical Investigation Plan
A signed statement by the natural or legal person responsible for the manufacture of the investigational device that the device in question conforms to the general safety and performance requirements.
Where applicable according to national law, copy of the opinion or opinions of the ethics committee or committees concerned
Proof of insurance cover or indemnification of subjects in case of injury, pursuant to Article 69 of MDR and the corresponding national law.
Documents to be used to obtain informed consent, including the patient information sheet and the informed consent document
Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data
Full details of the available technical documentationshall, upon request, be submitted to the competent authority reviewing an application
Structure of ISO 14155: 2020
Structure of ISO 14155:2020 Annexes
Annex A Clinical investigation plan (CIP) (normative)
Annex B Investigator’s brochure (IB) (normative)
Annex C Case report form (CRFs) (informative)
Annex D Clinical investigation report (normative)
Annex E Essential clinical investigation documents (informative)
Annex F Adverse event categorization (informative)
Annex G EC responsibilities (informative)
Annex H Application of ISO 14971 to clinical investigations (informative)
Annex I Clinical development stages(informative)
Annex J Clinical investigation audits (informative)