I'm not sure whether my clinical trial requires registration on ClinicalTrials.gov. How do I decide?

HSD will assess your study when you submit an IRB application or Request for External IRB Review in Zipline. See the related information on our main ClinicalTrials.gov webpage. Note: HSD’s assessment may be overridden by a federal agency or sponsor but not by the UW PI.

My study involves a drug or device but it doesn't need an IND or IDE from the FDA. Is it still an applicable clinical trial that requires registration on ClinicalTrials.gov?

Having an IND or IDE is not an essential part of the U.S. Food and Drug Administration’s (FDA) definition of ‘applicable clinical trial’ (ACT). Clinical trials that are determined to be ACTs per Section 801 of the Food and Drug Administration Amendments Act (FDAAA), are required to register and report results information on CT.gov. ACTs include the following:

• Controlled clinical investigations (other than phase 1 investigations) of any FDA-regulated drug or biological product for any disease or condition
• Certain studies of FDA-regulated medical devices, excluding small clinical trials to determine feasibility and certain clinical trials to test prototype devices, but including FDA-required pediatric postmarket surveillances of a device product

My clinical trial is being conducted with study participants in another country. Does it require registration on ClinicalTrials.gov'?

Yes, if the study meets FDAAA or National Institutes of Health (NIH) registration and results reporting requirements. Conducting the trial internationally does not exempt it from registration.

My study is an 'applicable clinical trial' as defined by the FDA and is also funded by NIH. Does that mean I need to register my study twice?

No. A single registration covers both requirements.

I am the PI on a UW site that is participating in a multi-site clinical trial. Do I need to register the study?

No, you do not need to register the study unless you are the sponsor or Lead PI for the overall trial.

My study is not yet approved by the IRB. Can I complete registration for it on ClinicalTrials.gov?

Yes, after you receive an email from HSD regarding initiation of trial registration. However, you must update the record when you receive IRB approval. If registration is voluntary, email hsdreprt@uw.edu to initiate study registration.

Can a study coordinator (or other person) register the trial instead of the PI?

Yes. Anyone who has a user account in ClinicalTrials.gov Protocol Registration and Results System (PRS) can enter the information in the record. However, entering the data requires someone who is thoroughly knowledgeable about the specific details of the study design, eligibility criteria, intervention/cohorts, and outcome measures. Entering study results may require someone with a deep understanding of the data and the statistical analyses that were performed. Regardless of who enters the information, only the Responsible Party (at UW, this is the PI) can initiate the Approve and Release actions required for the record.

I am the PI on two clinical trials. Do I need a different user account for each clinical trial?

No, unless you are acting as an agent of one institution for one trial and the agent of another institution for the second trial. You can use your UW user account for any number of clinical trials in which the UW is engaged in the research.

Is the registration process different for my studies that are reviewed by the Fred Hutch IRB?

The Fred Hutch Clinical Research Support (CRS) Office assists with the registration process for relevant oncology studies by Cancer Consortium members. Following the initial CT.gov registration, the CRS Office also provides assistance with subsequent record updates and results reporting questions. For assistance from the CRS Office, contact the CRS CT.gov team at CTgov@fredhutch.org. More information can also be found on the Cancer Consortium webpage.

What if my UW study is reviewed by a non-UW IRB, such as WCG IRB or Seattle Children's IRB?

If the UW study meets the criteria for registration and reporting on ClinicalTrials.gov, and you are the Responsible Party, you must register your study through the UWashington organizational PRS account, regardless which IRB conducts review.

Can I register my study any time after it has started, has closed to recruitment or has been completed?

Only if the registration is voluntary. For trials that are required to register, see our main ClinicalTrials.gov webpage for registration deadlines, as well as consequences and penalties for not registering as required.

When will the registration number (called the NCT number) be assigned to my study?

Your registration record must be “released” by the Responsible Party (the PI), and then it must be released by the ClinicalTrials.gov PRS staff after passing their QC (quality control) review. At that time, an email notification with the NCT number is sent. The record, including its NCT number, will typically be available on ClinicalTrials.gov within 2-5 business days after final release.

What are the most common causes of delayed PRS reviews?

PI failure to approve and release a study record. Failure to fully address PRS review comments. The PRS sends automated emails to the Record Owner and PI when additional actions are required. These emails are often overlooked or end up in a spam folder. For this reason, it is advisable to review the PRS record periodically after releasing an updated record for PRS review so that you can submit a timely response.

Do I need to tell my study participants that the trial will be registered?

Yes. The FDA regulations and the NIH policy require the following statement to be provided, without revision, in the consent form(s):

A description of this clinical trial will be available on http://www.clinicaltrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.

What should I tell my study participants if they are concerned about this website?

All results information is aggregated, summary level data. No data for individually-identifiable study participants is reported.

Can a clinical trial's record in ClinicalTrials.gov be transferred from one organization's account to another? (For example, when a PI moves to the UW from another institution, or leaves the UW)

Yes, and it is important to do this as soon as possible. Contact HSD through hsdreprt@uw.edu for assistance.

Am I still required to report results if my registered study terminates (stops prematurely) before completing the planned enrollment?

Yes, even if no study participants were ever recruited.

How do I submit results for a clinical trial that was terminated (i.e., stopped prematurely) and had no participants enrolled?

If no participants were enrolled in the trial, set the Overall Recruitment Status to Withdrawn, and no results information will need to be submitted.

How do I submit results for a terminated trial where participants were enrolled, but no data was collected for one or more Outcome Measures?

For a trial that was terminated after participants were enrolled, provide any available data. If no data are available for any of the Outcome Measures, specify zero (“0”) for the Number of Participants Analyzed and leave the data fields blank in each Arm/Group. Provide an explanation in the Analysis Population Description to explain that the trial was terminated before the outcome measure data were collected. If applicable, provide additional details in the Limitations and Caveats module. All other required results information collected for the enrolled participants will need to be submitted in each results module even though no data were collected for one or more Outcome Measures.

How will reporting my results on ClinicalTrials.gov affect my ability to publish the results?

There will be no effect on your ability to publish. The results are posted on ClinicalTrials.gov as aggregates and summaries. The International Committee of Medical Journal Editors (ICMJE) has stated that submission of summary results to ClinicalTrials.gov will not be considered to be “prior publication” and will therefore not interfere with journal publication.

Can I meet the results reporting requirement by uploading a manuscript or publication?

No. The results must be reported within the tabular format required by the PRS system.

My publisher is saying they cannot publish my results because the study wasn’t registered in ClinicalTrials.gov, even though registration wasn’t otherwise required. What do I do?

Contact the UW PRS administrators at hsdreprt@uw.edu as soon as possible to request assistance with study registration.

How do I confirm that my study results have been posted and no further actions on my part are required?

Results reporting is considered complete when the PRS record indicates ALL of the following: 1) ‘Overall Status’ = ‘Completed’, ‘Terminated’, or ‘Withdrawn’, 2) ‘Record Status’ = ‘Public’, 3) ‘Results Status’ = ‘Posted’, 4) there are no problems noted in the record, and 5) there is a final ‘Publish’ date under the PRS Review History link.