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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.

My study is not yet approved by a human subjects review board (ethics review committee, institutional review board).

Is there a charge for listing studies on ?.

Why Should I Register and Submit Results?ĭo you or someone you know want to participate in a clinical study? See information for patients and families.