FDA FDA 1501 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans How are “approval, licensure, or clearance of a new use” and “initial approval, licensure, or clearance” defined for the purposes of determining if a study may qualify for delayed submission of results information with certification? 1.27K viewsFDA 0 Votes 1 Ans When must I update clinical trial registration information? 1.96K viewsFDA 0 Votes 1 Ans What are the requirements for updating clinical trial registration information when a Human Subjects Review Board approves a protocol amendment? 1.67K viewsFDA 0 Votes 1 Ans What is the final rule’s effective date and compliance date? 1.84K viewsFDA 0 Votes 1 Ans To which trials do the potential legal consequences described in 42 CFR 11.66 apply? 1.71K viewsFDA 0 Votes 1 Ans What types of clinical trials are considered voluntary submissions subject to the regulation? 1.88K 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? 1.60K 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? 1.63K 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? 1.72K viewsFDA 0 Votes 1 Ans How do I determine if my study is an applicable clinical trial? 1.37K 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? 1.54K viewsFDA 0 Votes 1 Ans What is the definition of a drug, biological, or device product under investigation being “manufactured” in the United States? 1.76K 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.? 1.74K 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? 1.69K viewsFDA 0 Votes 1 Ans Are studies of Class I, II, and III devices required to be registered and submit results? 1.71K 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? 1.83K viewsFDA 0 Votes 1 Ans How do I determine who is the responsible party for a study? 1.62K viewsFDA 0 Votes 1 Ans Can the sponsor designate a principal investigator as the responsible party? 1.35K viewsFDA 0 Votes 1 Ans Who should submit an Expanded Access record? 1.88K 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? 1.79K viewsFDA « Previous 1 2 … 64 65 66 67 68 … 75 76 Next » Question and answer is powered by anspress.net
