Clinical Trials Registration and Reporting Questions and Answers
I'm not sure whether my clinical trial is an 'applicable clinical trial'. How do I decide?
Apply the definition provided here. Also, the ClinicalTrials.gov website has helpful information. Beginning in April, HSD will assess your study when you submit an IRB application or Request for External IRB Review in Zipline.
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?
Having an IND or IDE is not an essential part of the FDA’s definition of ‘applicable clinical trial’. See the complete description of applicable clinical trials.
My clinical trial is being conducted with subjects in another country. Is it an 'applicable clinical trial'?
Yes, in virtually all cases. Exception: clinical trials that are not subject to FDA regulations, are not funded by NIH, and do not have a site in the United States or its territories.
My study is an 'applicable clinical trial' as defined by NIH and by the FDA. Does that mean I need to register my study twice?
I am the PI on a UW site that is participating in a multi-site clinical trial. Do I need to register my study site?
No, you do not need to register unless you are the Lead PI for the overall trial.
My study is not yet approved by the IRB. Can I register it on ClinicalTrials.gov?
Yes. However, you must update the record when you receive IRB approval.
Can a study coordinator (or other person) register the trial instead of the PI?
Yes. Anyone who has a user account for the PRS data entry system at ClinicalTrials.gov can enter the information into the ClinicalTrials.gov system. 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 (the PI is strongly recommended for this role) 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 user account for any number of clinical trials.
Why is the registration process different for my studies that are reviewed by the Hutch IRB?
The NIH Cancer Consortium grant awarded to the UW, Hutch and SCCA has funding that allows it to do the registration process for Cancer Consortium members. It also provides significant assistance with updates and with results reporting. Contact the ClinicalTrials.gov administrator at the FHCRC Clinical Research Support Office: 206-667-4520.
What if my UW study is reviewed by some other non-UW IRB, such as WIRB or Seattle Children's IRB?
Unless your study is one of several sites in a multi-site clinical trial for which another site is assuming responsibility, you still must register your study and you must do so through the UWashington organization account. Exception: If the Hutch IRB reviewed your study, the Hutch Clinical Research Support Office will register your trial for you.
Can I register my study after it has started, has closed to recruitment or has been completed?
When will the registration number (called the NCT number) be assigned to my study?
Your registration record must be “released” by the Responsible Party and then it must be released by the ClinicalTrials.gov staff after passing their 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.
Do I need to tell my subjects 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 subjects if they are concerned about this website?
All results information is aggregated, summary level data. No data for individually-identifiable subjects is reported.
Am I still required to report results if my registered study terminates (stops prematurely) before completing the planned enrollment?
Yes, even if no subjects were ever recruited.
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 system.
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 firstname.lastname@example.org for assistance.