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.
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:
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.
No. A single registration covers both requirements.
No, you do not need to register the study unless you are the sponsor or Lead PI for the overall trial.
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.
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.
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.
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.
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.
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.
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.
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.
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.
All results information is aggregated, summary level data. No data for individually-identifiable study participants is reported.
Yes, and it is important to do this as soon as possible. Contact HSD through hsdreprt@uw.edu for assistance.
Yes, even if no study participants were ever recruited.
If no participants were enrolled in the trial, set the Overall Recruitment Status to Withdrawn, and no results information will need to be submitted.
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.
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.
No. The results must be reported within the tabular format required by the PRS system.
Contact the UW PRS administrators at hsdreprt@uw.edu as soon as possible to request assistance with study registration.
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.