- ISO 14155 is an international standard that specifies requirements for the planning, conduct, recording, and reporting of clinical investigations carried out on human subjects to assess the safety and performance of medical devices.
- The standard emphasizes the protection of human subjects as a primary consideration, ensuring that clinical investigations are conducted in accordance with ethical principles, sound scientific methodology, and regulatory requirements.
- Good Clinical Practice (GCP) principles are fundamental to the standard, providing a framework for the ethical and scientific quality standards in clinical investigations of medical devices.
- Risk management is integrated throughout the clinical investigation process, requiring ongoing assessment and mitigation of risks to subjects, while balancing these against potential benefits.
- The responsibilities of sponsors are clearly defined, including investigation planning, selection of qualified investigators, monitoring, data management, and safety reporting. Sponsors must ensure adequate resources and oversight throughout the investigation.
- Investigator responsibilities include subject protection, protocol adherence, data integrity, and adverse event reporting. Investigators must be qualified by education, training, and experience to conduct the investigation.
- Clinical investigation planning requires development of the Clinical Investigation Plan (CIP), which must include detailed information about investigation design, objectives, subject selection, procedures, and statistical considerations.
- Subject protection measures include informed consent procedures, ethics committee review and approval, privacy protection, and ongoing safety monitoring throughout the investigation.
- Documentation requirements are extensive, covering essential documents needed before, during, and after the clinical investigation. This includes source documents, case report forms, and investigation records.
- Monitoring procedures must be established to ensure subject protection, data quality, and protocol compliance. This includes site initiation, routine monitoring visits, and close-out activities.
- Adverse event reporting requirements specify timeframes and procedures for reporting serious adverse events and device deficiencies. This includes both immediate and periodic safety reporting.
- Data management systems must ensure data integrity, traceability, and security. Procedures for data collection, processing, and verification must be established and documented.
- Statistical considerations include sample size determination, analysis methods, and handling of missing data. The statistical analysis plan should be defined before investigation initiation.
- Quality control and quality assurance procedures must be implemented to ensure investigation quality and compliance with the protocol, standard, and regulatory requirements.
- Ethics committee interaction includes initial review and approval, ongoing reporting, and communication of significant changes or safety information throughout the investigation.
- Investigation closure procedures include site close-out activities, final reporting, and archiving of essential documents. Records must be retained according to applicable regulatory requirements.
- The Clinical Investigation Report must provide a comprehensive summary of the investigation results, including safety and performance outcomes, adverse events, and protocol deviations.
- Device accountability procedures must track device receipt, use, return, and/or disposal throughout the investigation. This includes maintaining appropriate documentation of device handling.
- Subject follow-up requirements ensure appropriate medical care and monitoring of subjects after their participation in the investigation, particularly for implantable devices.
- Protocol amendments must be properly documented and approved by relevant authorities, including ethics committees, before implementation.
- Investigational site selection criteria must ensure appropriate facilities, equipment, and qualified personnel for conducting the investigation safely and effectively.
- Training requirements for investigation personnel must be defined and documented, ensuring all staff are qualified for their assigned responsibilities.
- Risk-benefit assessment must be ongoing throughout the investigation, with procedures for prompt identification and evaluation of new safety information.
- Compliance with local regulatory requirements must be ensured, including obtaining necessary approvals and permits before investigation initiation.
- The standard promotes standardization of clinical investigation practices globally while allowing flexibility to meet local regulatory requirements and investigation-specific needs.
