3/14/2023 0 Comments Fda product builderPre-screening of records for eligibility determination.Discussing a study with potential subjects (but not obtaining consent). ![]() ![]() Data analysis (whether or not the data are identifiable).The activity(s) of UVA researchers on a non-UVA researcher’s FDA-regulated study is limited to:.Use of a custom device, if it is not intended to gather data about the device that will be submitted to (or held for) the FDA.Studies of surgical techniques that are evaluating only a new technique and not the safety or efficacy of FDA-regulated devices that are used during the surgery.Use of an HUD (Humanitarian Use Device) for patient care.The use of the aspirin or acetaminophen does not make the study subject to FDA regulations. Participants will be provided with aspirin or acetaminophen if they develop a headache due to the spinal tap. A study of biomarkers for Alzheimer’s disease will collect cerebrospinal fluid samples from participants.Use of a drug or device in a study, but the drug or device is not the focus of the study (and data about the item are not being gathered for submission to (or inspection by) the FDA).The use of the capsule does not make the study subject to FDA regulations. Body temperature will be measured by having the participants swallow a capsule designed by the PI’s lab that measures core temperature during the 10-20 hours that it takes the capsule to pass through the digestive system. A study is designed to look at the relationship between body temperature and self-reported hot flashes.The use of the statin does not make the study subject to FDA regulations. Participants will be given a FDA-approved statin drug after consuming citrus juice, and blood samples will be collected during the next 12 hours to examine the effect on statin metabolism.Use of a drug or medical device when the purpose is to obtain basic physiological information rather than gathering data for submission to (or inspection by) the FDA.In addition data from this study will not be submitted, or held for inspection, by the FDA. Study is IND exempt because it is determined the product being evaluated is not considered a drug because the intent of the study is only to evaluate the products effect on the structure or function of the body and is not intended to evaluate the products ability to diagnose, cure, mitigate, treat or prevent a disease.Interviews and questionnaires administered to subjects unless they involve the use of the test article, a human subject, and the data will be submitted to (or held for inspection by) the FDA.Screening tests and procedures when not performed solely for determining study eligibility.Medical records review (retrospective or prospective), ONLY IF the data is NOT submitted to the FDA.(NOTE: a study expedited under Expedited Category # 1 would be subject to FDA) ![]()
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