Clinical Trials Registration & Results Reporting

*Guidline for ClinicalTrials.gov best practices during COVID-19 can be found here*

ClinicalTrials.gov is a publicly available registry and results database of federally and privately supported clinical trials, and is supported by the U.S. National Library of Medicine. The purpose of ClinicalTrials.gov is to disclose to the public key information about clinical trials that are currently available or that have been conducted. All UW–Madison faculty, staff, and students conducting human subjects research on University premises are expected to follow federal registration and results reporting requirements regarding ClinicalTrial.gov.

Registration Requirements for ClinicalTrials.gov

There are three distinct entities that require Primary Investigators (PIs) to register their studies on ClinicalTrials.gov (CT.gov): The Food and Drug Administration (FDA), the National Institutes of Health (NIH), and the International Committee of Medical Journal Editors (ICMJE). All three of these groups have different criteria for determining which studies must be registered on CT.gov, and it is important to carefully review the criteria that your study might fall under: PIs submitting their study to the HS/MR IRBs need to look at FDA, NIH, and ICMJE, and PIs using the ED/SBS IRB only need to look at NIH and ICMJE.

If you have questions about the application of these registration requirements, please contact CT.gov Support using the information at the bottom of this page.

Additionally, the Center for Medicare & Medicaid Services (CMS) requires the registration of most studies billing third parties for study related services. For more information on the CMS requirements, contact Nancy Lutz, UW Health Research Compliance Billing Program at nlutz@uwhealth.org.

FDA Requirements for Registration and Results Reporting

The FDA requires study registration along with results and adverse event reporting for all phase II - IV interventional drug, biologic or device trials. This is a legal requirement (FDAAA 801); failing to register or report results for Applicable Clinical Trials (ACTs) in a timely manner can result in civil and significant monetary penalties.

For additional information on the FDA's registration requirements, please download the National Institutes of Health's Elaborations of Definitions of Responsible Party and Applicable Clinical Trial.

NIH Requirements for Registration and Results Reporting

All NIH-funded (in whole or in part) clinical trials are expected to register and submit results information to ClinicalTrials.gov, as per the NIH Policy on Dissemination of NIH-Funded Clinical Trial Information for competing applications and contract proposals submitted on or after 18 January 2017. This includes phase 1 clinical trials and trials that do not involve any FDA regulated product such as trials involving only behavioral interventions. More information on the NIH's registration and reporting requirements can be found on their website.

ICMJE Requirements for Registration

ICMJE requires study registration in a public trials registry as a condition of publishing in many peer-reviewed medical journals, including JAMA, NEJM, Annals of Internal Medicine, Lancet, etc. A study requires registration for ICMJE purposes if the following three criteria are met: (1) prospective assignment; (2) to a health-related intervention; (3) to study the cause-and-effect relationship between a health-related intervention and a health outcome.

Publication of interventional health outcome studies in journals adhering to the ICMJE Uniform Requirements for Manuscripts Submitted to Biomedical Journals is contingent on timely study registration. The ICMJE does not currently require results reporting.

  1. Prospective assignment: A study is “prospective” if it is not retrospective or, in other words, is one in which subjects are followed forward in time from a well-defined point.

  2. A health related intervention: Health related interventions are those activities used to modify a biomedical or health-related outcome. Examples include drugs, surgical procedures, devices, behavioral treatments, educational programs, dietary interventions; quality improvement interventions, and process-of-care changes.

  3. To study the cause-and-effect relationship between a health-related intervention and a health outcome: Health outcomes are any biomedical or health-related measures obtained in subjects, including pharmacokinetic measures and adverse events.

As of 1 July 2018 manuscripts submitted to ICMJE journals that report the results of clinical trials must contain a data sharing statement.

For additional information on the ICMJE's registration requirements, please visit the ICMJE's Clinical Trials Registration website, or refer to this Data Sharing tool.

Who is responsible for trial registration?

The study sponsor is generally responsible for trial registration and the sponsor must register all industry-sponsored trials.

However, the UW–Madison investigator is responsible for registration when one or more of the below conditions are met:

For additional information on the responsibility for trial registration, please download the National Institutes of Health's Elaborations of Definitions of Responsible Party and Applicable Clinical Trial.

When do you need to register your trial?

The FDA and NIH requires that all applicable clinical trials be registered within 21 days of the first subject's enrollment, and ICMJE requires trials to be registered prior to the first subject's enrollment.

However, the ClinicalTrials.gov registration process can involve multiple rounds of quality assurance comments and assignment of a National Clinical Trial (NCT) number can take up to two weeks (averaging 2-5 business days from submission). UW–Madison recommends starting the registration process as early as possible, incorporating it into your lab's workflow as your study begins the IRB approval process. For additional information on the quality assurance review process, please download the FDA's ClinicalTrials.gov Protocol Review Criteria. *NEW*: To make the process easier for researchers, UW-Madison has created a centralized ClinicalTrials.gov (CT.gov) service line. If you would like assistance with registration, maintenance, and/or results reporting process of your trial, please contact the UW Office of Clinical Trials ClinicalTrials.gov Specialists at CT.gov_HELP@clinicaltrials.wisc.edu.

Creating, Updating, and Reporting Results for Your ClinicalTrials.gov Record

Creating Your ClinicalTrials.gov Account

The University of Wisconsin is registered as an institution at ClinicalTrials.gov and has appointed ClinicalTrials.gov administrators to assist UW–Madison investigators or their designees in establishing their ClinicalTrials.gov accounts. To request a user login, send an email message to your assigned ClinicalTrials.gov administrator (see below) with your name, department, email address, and telephone number. You will then receive an email with a login name and a temporary password that will allow you to register your protocol.

Creating Your ClinicalTrials.gov Record

For a step-by-step explanation of how to register your study, visit ClinicalTrials.gov's website on How to Register Your Study. And for an explanation of the data fields within ClinicalTrials.gov, visit ClinicalTrials.gov's website on Data Elements Definitions.

Please complete the below data elements within ClinicalTrials.gov, as follows:

Updating Your ClinicalTrials.gov Record

Once your trial is registered, the FDA requires that your ClinicalTrials.gov record be updated within 30 days of a change in recruitment status or completion date, and your Record Verification Date needs to be updated at least every 12 months. CT.gov records are intended to be dynamic and kept up to date to reflect the most recently IRB approved version of your study protocol; it should be updated whenever you receive IRB approval for a change to your protocol. For a further explanation of how to update your record, visit ClinicalTrials.gov's website on How to Edit Your Study Record.

Consent Forms

The Revised Common Rule requires that federally funded studies meeting the definition of a clinical trial must post one IRB-approved informed consent form (ICF) that was used to enroll subjects to a publicly available website, such as ClinicalTrials.gov. The informed consent form must be posted after the trial is closed to enrollment, but no later than 60 days after the last study visit by any subject.

Results

Reporting Results for Your ClinicalTrials.gov Record: Results reporting is required for studies that meet the FDA registration requirements ("applicable clinical trials") or receive any NIH funding. Results should not be reported when only the ICMJE registration requirements apply.

ClinicalTrials.gov has four results reporting modules:

For a step-by-step explanation of how to report results, visit ClinicalTrials.gov's website on How to Submit Your Results. ClinicalTrials.gov also provides a very helpful Pre-Submission Checklist for results reporting.

When do you need to report results for your trial?: The FDA requires that the results of "applicable clinical trials" be reported within 12 months of the last subject's last study visit, which should be listed in ClinicalTrials.gov as the study's "primary completion date." Failing to properly update the "primary completion date" during the study may lead the FDA to believe that results should be posted before the study is actually completed. For additional information on the "primary completion date" within in ClinicalTrials.gov, please see ClinicalTrials.gov Data Element Definitions.

If the clinical trial is NIH-funded in whole or in part, expectations for clinical trial summary results submission within 12 months of the last subject's last study visit should be included in the terms and conditions of the award.  Failure to comply with the terms and conditions of the NIH award may provide a basis for enforcement actions, including termination, consistent with 45 CFR 75.371 and/or other authorities, as appropriate. More information can be found on the UW RSP NIH clinical trials page.

Contact Information

For questions concerning this website or clinical trials registration at UW–Madison, please contact:
CT.gov Support, Office of Research Compliance at (608) 890-1241 or ClinicalTrials.gov_Support@research.wisc.edu