Are the participants prospectively assigned to an intervention? Is the study designed to evaluate the effect of the intervention on the participants? Clinical trials are clinical research studies. How can researchers determine whether a proposed study is a clinical trial? The following questions should be used to determine whether a study meets the NIH clinical trial definition: Does the study involve human participants?
Are the participants prospectively assigned to an intervention? Is the study designed to evaluate the effect of the intervention on the participants? Is the effect being evaluated a health-related biomedical or behavioral outcome? Does the primary outcome of a study need to be a health-related outcome in order for a study to be considered a clinical trial? What is the difference between the clinical trial definition in the revised Common Rule and the NIH clinical trial definition?
NIH considers the two definitions to have the same meaning. What is the sub-definition of "intervention"? Are measurements the same as interventions? No; measurements are used to evaluate outcomes.
Does the NIH clinical trial definition apply to foreign awards? How will NIH educate researchers? Specific Cases If a proposed clinical study includes a plan for addressing incidental findings, is the study considered to be a clinical trial? Are studies that propose to evaluate a clinical intervention or to develop a diagnostic tool considered to be clinical trials? Are studies that elicit the opinions or preferences from human participants considered to be clinical trials?
No; studies eliciting opinions or preferences are not considered to be health-related outcomes. Are observational studies, which do not include an intervention, considered to be clinical trials? No; in order to meet the NIH clinical trial definition there must be an intervention. Are studies that involve only healthy participants considered to be clinical trials? Are studies that are not designed to impact diagnoses or treatment of patients considered to be clinical trials?
See Case Studies 8a-c Are studies designed to investigate whether a technique can be used to measure a response in research participants considered to be clinical trials? Source Document — Original documents, data, and records e. Standard Operating Procedure SOPs — Detailed written instructions to achieve uniformity of the performance of a specific function across studies and patients at an individual site.
Stopping Rules —Established safety criteria that would either pause or halt a study due to reasons including but not limited to futility or risk s to the participants. Stratification — Separation of a study cohort into subgroups or strata according to specific characteristics such as age, gender, etc. Unanticipated Problems UAPs — Unanticipated problems involving risks to subjects or others, which meet all of the following criteria:. Unanticipated Adverse Device Effects UADEs — Any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, problem, or death was not previously identified in a nature, severity, or degree of incidence in the investigational plan or application including a supplementary plan or application or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects.
Clinical Trials. Patient Resources: Glossary. Fundamentals of Clinical Trials 3 ed. Missouri: Mosby-Year Book Inc. Meinert CL. Clinical Trials: Design, Conduct, and Analysis. Research conducted with human subjects or on material of human origin such as tissues, specimens and cognitive phenomena for which an investigator directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual.
Patient-oriented research includes: a mechanisms of human disease, b therapeutic interventions, c clinical trials, or d development of new technologies. Epidemiologic and behavioral studies. Outcomes research and health services research.
Serious Adverse Event SAE — Any adverse event that: Results in death Is life threatening, or places the participant at immediate risk of death from the event as it occurred Requires or prolongs hospitalization Causes persistent or significant disability or incapacity Results in congenital anomalies or birth defects Is another condition which investigators judge to represent significant hazards Source Document — Original documents, data, and records e.
Unanticipated Problems UAPs — Unanticipated problems involving risks to subjects or others, which meet all of the following criteria: Unexpected in terms of nature, severity, or frequency; Related or possibly related to participation in the research, and; Suggests that the research placces subjects or others at a greater risk of harm including physical, psychological, economic, or social harm than was previously known or recognized.
Glossary Sources: Clinical Trials. Related Content. Investigators are the scientists performing clinical research from varied disciplines with a range of academic qualifications e. Participants are the human volunteers, medical information and biological materials of human origin, or data derived from volunteers. Participants may have particular health conditions or may be healthy volunteers or populations at large.
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