Clinical Trials & Evaluation Flashcards
What are the key differences between significant risk (SR) and non-significant risk (NSR) device studies?
SR studies require both FDA and IRB approval before beginning, while NSR studies require only IRB approval. SR studies involve devices that present a potential for serious risk to health, safety, or welfare of subjects. SR studies must follow all IDE regulations, while NSR studies follow abbreviated requirements.
What is informed consent in clinical investigations?
Informed consent is the process by which subjects voluntarily confirm their willingness to participate in a clinical investigation after being informed of all aspects relevant to their decision. It must be documented in a written form signed and dated by the subject (or legally authorized representative).
What elements must be included in an informed consent document?
Key elements include: explanation of research purpose, description of procedures, risks and benefits, alternative procedures, confidentiality measures, compensation for injury, voluntary participation statement, contact information, and statement that FDA may inspect records.
What is the role of an Institutional Review Board (IRB) in device clinical trials?
An IRB reviews and approves clinical investigation protocols involving human subjects to ensure protection of subjects’ rights, safety, and welfare. IRBs review study protocols, informed consent documents, investigator qualifications, and monitor ongoing studies.
What documentation is typically included in a clinical investigation plan?
A clinical investigation plan typically includes: study objectives, design, endpoints, subject selection criteria, procedures, statistical considerations, data collection methods, risk analysis, monitoring procedures, and investigator responsibilities.
What is the difference between a prospective and retrospective clinical study?
A prospective study follows subjects forward in time, collecting data as events occur. A retrospective study looks backward in time, using existing data that was collected for reasons other than the study. Prospective studies are generally considered stronger evidence but take longer to complete.
What are the key elements of Good Clinical Practice (GCP)?
GCP principles include: ethical conduct, risk/benefit assessment, qualified investigators, informed consent, quality assurance, protocol compliance, data integrity, confidentiality, and appropriate monitoring.
What is a clinical endpoint?
A clinical endpoint is a characteristic or variable that reflects how a patient feels, functions, or survives. It’s used to objectively determine the effectiveness of an intervention in a clinical study. Endpoints can be primary (main outcome) or secondary (additional outcomes).
What is clinical evaluation for medical devices in the EU context?
Clinical evaluation is the assessment and analysis of clinical data pertaining to a medical device to verify its clinical safety and performance. Under EU MDR, it’s a systematic and planned process that must be conducted throughout the device lifecycle and documented in a Clinical Evaluation Report (CER).
What is a Post-Market Clinical Follow-up (PMCF) study?
A PMCF study is a proactive collection of clinical data after a device is CE marked to confirm safety and performance throughout the expected device lifetime, identify previously unknown side-effects, and monitor identified risks. It’s part of post-market surveillance under EU MDR.
