Key Documentation For Iso 14155 Clinical Investigations

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ISO 14155 provides guidelines for the clinical investigation of medical devices, ensuring that studies are conducted ethically, scientifically, and in compliance with regulatory standards. Proper documentation is essential for maintaining transparency, accountability, and participant safety throughout the clinical investigation process. Below are the key documentation requirements under ISO 14155.

Clinical Investigation Plan (CIP): The Clinical Investigation Plan (CIP) is a critical document that outlines the study’s design, objectives, methodology, and statistical analysis plan. It includes inclusion and exclusion criteria for participants, risk management procedures, data collection methods, and ethical considerations. The CIP ensures the study is organized, consistent, and focused on evaluating the safety and performance of the medical device.

Informed Consent Forms (ICF): Informed consent is a fundamental requirement in clinical studies, ensuring that participants are fully aware of the risks and procedures involved before agreeing to participate. The Informed Consent Form (ICF) must explain the study’s ...
... purpose, potential risks, procedures, and the participant's right to withdraw at any time. This documentation is critical to respecting participants' rights and autonomy.

Investigator’s Brochure (IB): The Investigator’s Brochure (IB) provides detailed information about the investigational device, including preclinical data, safety profiles, and potential risks. The IB helps investigators understand the device’s properties, allowing for informed decision-making during the study. It is regularly updated to reflect new information or changes in the safety profile of the device.

Case Report Forms (CRFs): Case Report Forms (CRFs) are used to collect data from each participant during the clinical investigation. These forms capture important information such as demographics, medical history, device usage, and any adverse events. CRFs ensure consistent and accurate data collection throughout the study, which is vital for analyzing the investigation’s outcomes.

Adverse Event Reports: Adverse events related to the device must be documented and reported according to ISO 14155. These reports should detail the nature, severity, and actions taken in response to the event. Timely and accurate reporting ensures participant safety and complies with regulatory requirements.

Ethics Committee Approvals: Before beginning a clinical investigation, approval from an independent ethics committee or institutional review board (IRB) is required. Documentation of the approval, including the date and any conditions, is essential. This ensures that the study meets ethical standards and protects participants' rights.

Monitoring and Audit Reports: Monitoring and auditing are essential for ensuring that the study adheres to the CIP and maintains ethical and regulatory compliance. Monitoring reports document the results of visits to study sites, highlighting any deviations or non-conformances, while audit reports assess overall study integrity. These reports ensure transparency and help maintain compliance.

Final Report of the Clinical Investigation: A final report summarizes the study’s findings, including the results of the statistical analysis, safety evaluations, and recommendations for future research. This report is a crucial part of regulatory submissions and demonstrates the validity and reliability of the clinical investigation’s outcomes.

Data Management Plan (DMP): A Data Management Plan (DMP) outlines how data will be collected, stored, and analyzed throughout the clinical investigation. It ensures data integrity, protects participant privacy, and complies with relevant regulations.

ISO 14155 Documentation are essential to ensuring that clinical investigations of medical devices are ethically conducted, scientifically valid, and regulatory compliant. By maintaining comprehensive records in these ISO 14155 documents organizations can safeguard participant safety, enhance data integrity, and streamline regulatory approvals, ultimately supporting the development of safe and effective medical devices.

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