| AE | Adverse Event | Any untoward medical occurrence in a subject, whether or not related to the device. |
| CEP | Clinical Evaluation Plan | EU MDR document that defines the scope, methods, and acceptance criteria for the clinical evaluation that will be reported in the Clinical Evaluation Report (CER). |
| CER | Clinical Evaluation Report | Documented assessment of clinical data demonstrating EU MDR conformity for a device. |
| CIP | Clinical Investigation Plan | EU MDR's term for the protocol document governing a clinical investigation of a device. |
| CRF | Case Report Form | Structured paper or electronic forms used to capture protocol-required data for each enrolled subject. |
| DCT | Decentralized Clinical Trial | A trial that uses telehealth, home-based assessments, wearables, and direct-to-patient logistics to reduce or eliminate site visits. |
| DSMB | Data Safety Monitoring Board | Independent committee that periodically reviews accumulating safety and (sometimes) efficacy data during a trial. |
| EDC | Electronic Data Capture | Software systems used to collect, manage, and report clinical trial data electronically, replacing paper case report forms. |
| EFS | Early Feasibility Study | FDA program enabling early human evaluation of novel devices with limited preclinical data and iterative design. |
| ePRO | Electronic Patient-Reported Outcome | A patient-reported outcome instrument administered and captured electronically, subject to validation and 21 CFR Part 11 data-integrity requirements when used in FDA-regulated trials. |
| FIH | First-in-Human Study | First clinical use of a device or therapy in humans, often outside the U.S. before a U.S. EFS. |
| GCPmore than one meaning | ICH E6 Good Clinical Practice | International standard for the design, conduct, and reporting of clinical trials. |
| HFE | Human Factors Engineering | Engineering discipline focused on safe and effective device use by intended users. |
| IB | Investigator Brochure | Compilation of clinical and nonclinical information on an investigational device given to clinical investigators, establishes what's 'anticipated' for UADE determinations. |
| IDE | Investigational Device Exemption | FDA authorization to use an investigational device in a clinical study. |
| IIT | Investigator-Initiated Trial | A clinical trial where an individual investigator (typically academic), not the device or drug manufacturer, holds the regulatory sponsor role and is responsible for IRB, IDE/IND, and conduct. |
| IRB | Institutional Review Board | Board that reviews and approves human-subjects research at an institution. |
| ITT / PP | Intent-to-Treat vs Per-Protocol | Two analysis populations: ITT analyzes everyone randomized; PP analyzes only those compliant with protocol. |
| LoD / LoQ | Limit of Detection / Limit of Quantitation | Lowest analyte concentrations an assay can reliably detect (LoD) or quantify (LoQ). |
| MCID | Minimal Clinically Important Difference | Smallest change in a measurement that patients perceive as clinically meaningful. |
| PGx | Pharmacogenomics | The study of how genetic variation affects an individual's response to drugs, used to guide dosing, drug selection, and companion diagnostic development. |
| RBM | Risk-Based Monitoring | Monitoring strategy that targets oversight resources to the highest-risk sites, processes, and data based on a documented risk assessment, replacing 100% source data verification. |
| RWD | Real-World Data | Data relating to patient health status or care delivery routinely collected from sources other than traditional clinical trials, the inputs from which Real-World Evidence is derived. |
| RWE | Real-World Evidence | Clinical evidence regarding the usage and potential benefits or risks of a device derived from real-world data. |
| SAE | Serious Adverse Event | Adverse event resulting in death, life-threat, hospitalization, persistent disability, or congenital anomaly. |
| SDV | Source Data Verification | Process of comparing data in case report forms against original source records. |
| TMF | Trial Master File | The collection of essential documents that demonstrates the conduct of a clinical trial complies with GCP and applicable regulatory requirements. |
| UADE | Unanticipated Adverse Device Effect | Any serious adverse effect on health or safety in an IDE study not previously identified in the investigational plan, triggers strict reporting timelines. |