ClinicalTrials.gov

• How do I report errors in ClinicalTrials.gov?

• How will I be protected if I join a study?

• What is the final rule's effective date and compliance date?

• Where do clinical studies take place?

• How often are studies updated in ClinicalTrials.gov?

• Can I register a study after it has started, has closed to recruitment, or has been completed?

• Can an organization have multiple PRS users for a single account?

• How do I find the results of a clinical trial?

• Will my health insurance cover costs if I join a clinical trial?

• What happens in an observational study?

• How long do clinical studies last?

• How can my company submit data to ClinicalTrials.gov?

• When must I submit the required clinical trial registration information?

• What is a clinical study?

• Can I contact a study sponsor?

• How do I contact ClinicalTrials.gov if I have a question about my study record?

• What questions should I ask when trying to decide whether to join a clinical study?

• Who can join a clinical study?

• Do I still see my regular doctors when I'm in a clinical study?

• How do I know if I'm eligible to join a clinical study?

• How do I sign up for a trial on ClinicalTrials.gov?

• Can I participate in a clinical trial?

• When will the NCT Number for my study be assigned?

• What registration information must I submit if my applicable clinical trial is required to be registered?

• How do I find information on expanded access studies in ClinicalTrials.gov?

• What else should I think about before deciding to join a study?

• What kind of web site is ClinicalTrials.gov?

• How do I find a study I want to join?

• How is a clinical study done?

• Can I join a clinical trial if I live outside the United States?

• Who conducts clinical studies?

• What is the definition of a drug, biological, or device product under investigation being "manufactured" in the United States?

• 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.?

• What happens in a clinical trial?

• What is the results information submission deadline for applicable clinical trials (ACTs) of drug, biological, or device products that are not approved, licensed, or cleared for any use and studied in conjunction with, or in comparison to, approved, licensed, or cleared products?

• What are the requirements for updating clinical trial registration information when a Human Subjects Review Board approves a protocol amendment?

• To which trials do the potential legal consequences described in 42 CFR 11.66 apply?

• How are examinations by telephone call or other electronic means considered in determining when an applicable clinical trial reaches its "primary completion date" or "study completion date" under the regulation?

• What is an Institutional Review Board?

• What can I do on the ClinicalTrials.gov web site?

• What information can I find on the ClinicalTrials.gov web site?

• Is there a charge for listing my study on ClinicalTrials.gov?

• 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?

• Must clinical studies with no external sources of funding ("unfunded" studies) be registered on ClinicalTrials.gov?

• Do I need to register each single-patient investigational new drug application (IND) or protocol exception (including for emergency use) separately?

• To comply with FDAAA 801, must I submit information to ClinicalTrials.gov, or can I use another registry or results database?

• Does FDAAA 801 only apply to Industry-sponsored studies?

• 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)?

• Can protocol information be uploaded electronically to ClinicalTrials.gov?

• 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?

• 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?

• Can an investigator reference a published paper instead of entering all of the results data into ClinicalTrials.gov?

• How do I determine if my study is an applicable clinical 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. site, am I required to register the trial?

• If my study is an applicable clinical trial (ACT), am I required to register?

• Am I required to submit results information for my applicable clinical trial (ACT)?

• When is required clinical trial results information due?

• Who should submit an Expanded Access record?