Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans What is the final rule’s effective date and compliance date? 1.88K viewsFDA 0 Votes 1 Ans To which trials do the potential legal consequences described in 42 CFR 11.66 apply? 1.75K viewsFDA 0 Votes 1 Ans What types of clinical trials are considered voluntary submissions subject to the regulation? 1.92K viewsFDA 0 Votes 1 Ans Am I required to submit to ClinicalTrials.gov the results of a clinical trial that is not an applicable clinical trial? 1.64K viewsFDA 0 Votes 1 Ans How do I submit results information if the trial is terminated (that is, stopped prematurely) and no data were collected for one or more Outcome Measures? 1.66K viewsFDA 0 Votes 1 Ans I completed a clinical trial that studied an investigational product (drug, biological product, or device that is not initially approved, licensed, or cleared by the FDA). There is no intent to seek approval, clearance, or licensure of the product by the FDA (for example, development of the investigational product has been terminated). How do I indicate that results need not be submitted for this trial? 1.77K viewsFDA 0 Votes 1 Ans How do I determine if my study is an applicable clinical trial? 1.41K viewsFDA 0 Votes 1 Ans If a clinical trial is not an applicable clinical trial (ACT) at study initiation because it is conducted entirely outside the United States, but the trial subsequently opens a U.S. site, am I required to register the trial? 1.57K viewsFDA 0 Votes 1 Ans What is the definition of a drug, biological, or device product under investigation being “manufactured” in the United States? 1.80K viewsFDA 0 Votes 1 Ans How do I know if my clinical trial “Studies a U.S. FDA-regulated Drug Product” or “Studies a U.S. FDA-regulated Device Product” when evaluating whether it is an applicable clinical trial (ACT) subject to the regulation under the conditions specified in 42 CFR 11.22(b)? Specifically, for a trial conducted entirely outside the U.S.? 1.78K viewsFDA 0 Votes 1 Ans Is a clinical trial that uses a radiation-emitting product considered to be a trial that “Studies a U.S. FDA-regulated Device Product” under 42 CFR Part 11? 1.73K viewsFDA 0 Votes 1 Ans Are studies of Class I, II, and III devices required to be registered and submit results? 1.73K viewsFDA 0 Votes 1 Ans Is a study coordinating center located in the United States considered to be a “Facility Location” within the United States for evaluating whether a study is an applicable clinical trial? 1.89K viewsFDA 0 Votes 1 Ans How do I determine who is the responsible party for a study? 1.67K viewsFDA 0 Votes 1 Ans Can the sponsor designate a principal investigator as the responsible party? 1.39K viewsFDA 0 Votes 1 Ans Who should submit an Expanded Access record? 1.98K viewsFDA 0 Votes 1 Ans Who is the responsible party for a pediatric postmarket surveillance of a device product that is not a clinical trial? 1.86K viewsFDA 0 Votes 1 Ans Is there a charge for listing studies on ClinicalTrials.gov? 1.94K viewsFDA 0 Votes 1 Ans My study is not yet approved by a human subjects review board (ethics review committee, institutional review board). Can I enter it on ClinicalTrials.gov? 1.89K viewsFDA 0 Votes 1 Ans Why can’t I find my study on ClinicalTrials.gov? 1.94K viewsFDA « Previous 1 2 … 252 253 254 255 256 … 283 284 Next » Question and answer is powered by anspress.net
