When must I submit the required clinical trial registration information?.What registration information must I submit if my applicable clinical trial is required to be registered?.If my study is an applicable clinical trial (ACT), am I required to register?.Registration Information and Submission Deadlines.Who is the responsible party for a pediatric postmarket surveillance of a device product that is not a clinical trial?.
Can the sponsor designate a principal investigator as the responsible party?.How do I determine who is the responsible party for a study?.Are "pilot" drug or device studies considered to be an "applicable drug clinical trial" or "applicable device clinical trial," respectively, under the regulation?.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?.Are studies of Class I, II, and III devices required to be registered and submit results?.FDA-regulated Device Product" under 42 CFR Part 11? Is a clinical trial that uses a radiation-emitting product considered to be a trial that "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.? FDA-regulated Drug Product" or "Studies a U.S. How do I know if my clinical trial "Studies a U.S.What is the definition of a drug, biological, or device product under investigation being "manufactured" in the United States?.site, am I required to register the trial? 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.How do I determine if my study is an applicable clinical trial?.Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11).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?.Am I required to submit to the results of a clinical trial that is not an applicable clinical trial?.Does the definition of applicable clinical trial under FDAAA 801 only include studies conducted under an FDA Investigational New Drug Application (IND) or Investigational Device Exemption (IDE)?.Does FDAAA 801 only apply to industry-sponsored studies?.To comply with FDAAA 801, must I submit information to, or can I use another registry or results database?.Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801).Can registration and results information be uploaded electronically to ?.Can an organization have multiple users for a single account?.Protocol Registration and Results System (PRS).Do I need to register each single-patient investigational new drug application (IND) or protocol exception (including for emergency use) separately?.How do I contact if I have a question about my study record?.Must clinical studies with no external sources of funding ("unfunded" studies) be registered at ?.Can I register a study after it has started, has closed to recruitment, or has been completed?.When will the NCT Number for my study be assigned?.How do I indicate this exemption when registering the clinical trial at ? My clinical trial evaluating a benign behavioral intervention is exempt human subjects research per Exemption 3 outlined in 45 CFR 46.
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