Glossary: Evidence Generation in Clinical Studies – Functional Imaging
Completion requirements
| Term | Definition |
|---|---|
| Clinical Evidence | Verified data demonstrating the safety, performance, and clinical benefit of a medical device, obtained through clinical studies or post-market data. |
| Evidence Generation | The systematic process of collecting, analyzing, and interpreting clinical data to support regulatory approval and clinical use of medical technologies. |
| Functional Imaging | A type of medical imaging (e.g., fMRI, PET) that measures physiological or metabolic activity, providing insight into organ or brain function rather than just structure. |
| Clinical Study | A structured investigation conducted on human subjects to evaluate the safety or effectiveness of a medical device, drug, or imaging method. |
| Endpoint | A specific measurement or outcome used to assess the effect of a medical intervention in a clinical study. |
| Regulatory Compliance | Adherence to the rules and guidelines set by authorities such as the European Commission, EMA, or national health agencies for conducting and reporting clinical research. |
| MDR (Medical Device Regulation) | EU Regulation (EU) 2017/745 establishing requirements for the safety and clinical evaluation of medical devices. |
| IVDR (In Vitro Diagnostic Regulation) | EU Regulation (EU) 2017/746 setting standards for in vitro diagnostic devices, including clinical evidence requirements. |
| Clinical Evaluation | The assessment and analysis of clinical data to verify the clinical safety and performance of a medical device. |
| Performance Evaluation | For diagnostic devices, the process of demonstrating that the device produces results consistent with its intended purpose. |
| Real-World Evidence (RWE) | Evidence derived from real-world data (registries, EHRs, post-market studies) rather than controlled clinical trials. |
| Study Protocol | A written plan detailing the study’s objectives, methodology, design, and statistical approach, used to ensure consistency and quality. |
| Data Quality | The accuracy, completeness, and reliability of data collected during a clinical study, essential for valid conclusions. |
| Reproducibility | The ability to achieve consistent results when a study or experiment is repeated under the same conditions. |
| Imaging Biomarker | A measurable characteristic derived from imaging (e.g., metabolic rate, perfusion, activation pattern) that serves as an indicator of normal or pathological processes. |