ClinicalTrials.gov

 

Overview

Clinical trials must comply with many requirements that do not apply to other types of human subjects research. These requirements are designed to address the increased participant vulnerability and risks of many clinical trials compared with other research. They are also meant to ensure meaningful results.

Federal agencies, such as the National Institutes of Health (NIH) and U.S. Food and Drug Administration (FDA), require information about clinical trials to be placed in the public database called ClinicalTrials.gov (CT.gov). Specifically, the trials must be registered in the CT.gov Protocol Registration and Results System (PRS) when they begin. The PRS study record must be updated throughout the study and study results must be reported when the study ends. Significant penalties can be applied by the agencies if these requirements are not met – including loss of an investigator’s ongoing or pending grant funding.

Who is Responsible for CT.gov Requirements?

A UW Principal Investigator (PI) may be designated as the Responsible Party for ClinicalTrials.gov registration and results reporting only if they are conducting the trial, have control over the data, and have been formally delegated this role by the sponsor or awardee. In multi-center trials, the lead sponsor or lead PI is typically responsible. For industry-sponsored trials, the sponsor is usually responsible. For NIH-funded trials, the primary awardee must ensure compliance. The holder of any IND, IDE, or HDE is also responsible under FDA regulations.

UW studies reviewed by the Fred Hutchinson IRB
For clinical trials where the UW PI is the responsible party and a Cancer Consortium member, the Cancer Consortium Clinical Research Support office will: (1) assist with registration and (2) provide support with subsequent record updates and results reporting questions.

Which Clinical Trials Require Registration and Results Reporting on ClinicalTrials.gov?

HSD currently monitors and supports registration and results reporting on CT.gov for clinical trials that are FDAAA Applicable Clinical Trials (ACT) and/or NIH-funded. Other agencies, sponsors, and organizations (e.g., Medicare, DoD, ICMJE) may also require registration and results reporting but HSD does not track or enforce these requirements. The UW PI is responsible for ensuring they are aware of and comply with any registration and reporting requirements on CT.gov outside those required under FDAAA or NIH.

FDAAA Applicable Clinical Trials (ACT)

Clinical trials that are determined to be Applicable Clinical Trials (ACT) per Section 801 of the Food and Drug Administration Amendments Act (FDAAA), are required to register and report results information on CT.gov. Information about the requirements for registering and reporting results for ACTs can be found on the CT.gov FDAAA 801 and Final Rule webpage.

NIH-Funded Clinical Trials

All NIH-funded Clinical trials are expected to register and submit results information to CT.gov, as per the NIH Policy on Dissemination of NIH-Funded Clinical Trial Information. Information about NIH’s requirements for registering and reporting NIH-funded clinical trials can be found on the CT.gov Requirements for Registering & Reporting NIH-Funded Clinical Trials webpage.

Clinical Trial Registration and Reporting Process

Initial CT.gov assessment

HSD reviews all incoming IRB applications and certain study modifications to determine whether the study is required to register and report results on CT.gov and whether such studies should be registered under the UW‘s PRS account. For this reason, all UW clinical trials that require registration under UW’s group PRS account should be initiated by a UW PRS Administrator at HSD.

Per HSD policy, clinical trial assessments are not completed until the IRB application or modification has been submitted to HSD. If an assessment is needed while preparing an NIH grant application, please reach out to your contact at the NIH funding agency for further guidance.
For studies where registration is required, HSD staff automatically initiates the CT.gov registration and communicates this information and the required next steps to the PI and study team via email.

When to register and report results

Initial registration – No later than 21 days after enrollment of the first study participant or within 1 year of IRB approval (HSD policy), whichever occurs first.

Interim updates – The record must be updated at least once a year (even if nothing has changed) until final results are reported. Certain types of changes must be reported within 15 or 30 days. See How to Update a Record or Report Results in ClinicalTrials.gov for details.

Results reporting – No later than one year after the trial’s primary completion date. For information about exceptions, see How to Update a Record or Report Results in ClinicalTrials.gov.

Correction of errors – Within 15 days for registration information; Within 25 days for results information

PI responsibilities

The PI is responsible for:

• Completing registration and results reporting through the PRS by the prescribed deadlines
• The accuracy and completeness of the information entered in the PRS
• The Approve and Release actions that are required each time information is entered into the trial record
• Obtaining an account with the PRS to log into the system for the Approval and Release actions

The PI may delegate the responsibility for entering the information required for registration, updates, and results reporting to another member of the study team. An extensive amount of detailed information is required for this responsibility. The knowledge and time necessary to create a record (register the trial) and enter results should not be underestimated.

Initial registration and updates

Registration and updates to the study record in PRS should be done by a person who knows the details of study design, eligibility criteria, outcome measures, and study status. Specific deadlines and requirements for updating study information is required. For more information on how to update a record visit How to Update a Record or Report Results in ClinicalTrials.gov.

Results reporting

Reporting clinical trial results to CT.gov is essential for ensuring transparency, accountability, and public trust in medical research. It allows outcomes—whether favorable, unfavorable, or inconclusive—to be publicly accessible, helping to prevent duplication of research and support evidence-based decision-making. Under U.S. regulations like FDAAA 801 and the NIH Policy on Dissemination of NIH-Funded Clinical Trial Information, researchers are legally required to submit results to ClinicalTrials.gov. The information required for results reporting should be prepared by a person who knows the details of study design and analysis, such as an investigator or statistician, although others could then enter the information. For more information on how to update report results visit How to Update a Record or Report Results in ClinicalTrials.gov.

Voluntary registration

Researchers who are not required under FDAAA or NIH policy to register but want to voluntarily register or are required for other reasons (e.g., Sponsor requirement) should email the UW PRS Administrators at hsdreprt@uw.edu. HSD will initiate the study registration and communicate the required next steps to you via email. However, HSD does not track registration and results reporting requirements for these registrations.

Note: Whether CT.gov study registration is required or not, the researcher should understand the registration and reporting timeline requirements for submission.

Consequences and Penalties for Late Registration/Results Reporting

Human Subjects Division

UW IRB approval for a clinical trial will not be renewed and restrictions will be placed on other existing studies under the same UW PI if the clinical trial registration has not been completed by the registration deadline. UW PIs that fail to report results by the deadline may be reported to their department heads for further follow up.

NIH-sponsored research

For clinical trials required to register/report under NIH policy, all of the following may occur:

• Public notice of noncompliance at ClinicalTrials.gov.
• UW researchers who receive a Pre-Notice or Notice of Noncompliance email or letter from NIH should contact HSD at hsdreprt@uw.edu as soon as possible for guidance.
• HHS agencies (e.g., NIH) may withhold funds for existing grants and/or awards of new funding to the PI
• HHS research funding to the entire institution could be withheld

Clinical Trials Subject to FDAAA

For studies required to register/report under FDAA:

• All of the actions listed above for NIH-sponsored research plus;
• Civil monetary penalties for the responsible party (for trials registered under the UW account, that is the PI)

Committee of Medical Journal Editors (ICMJE)

Although HSD does not track or enforce this, the ICMJE requires, and recommends that all medical journal editors require, registration of clinical trials in a public trials registry at or before the time of first patient enrollment as a condition of consideration for publication. Further details regarding these requirements are available on the ICMJE’s website. Failure to register or report results for a clinical trial may result in an inability to publish in prominent medical journals.

Other Requirements for Clinical trials

Institutional review and billing for clinical study procedures

All clinical trials performed at the UW or Fred Hutch Cancer Center (FHCC) facilities or by UW Physicians-credentialed investigators must be submitted for institutional review by the UW Clinical Trials Office (CTO) via the REDCap-based Study Intake Form. This is a single intake process that will help navigate the required operational and compliance reviews (e.g., Clinical Trial Management System, Investigational Drug Services, Radiology, etc.) and available resources (research nursing, study coordination, regulatory services, budget negotiation, etc.) for smoother start-up and successful and compliant conduct of clinical trials. This submission will generate a unique study “RG” identifier (aka “RG number” or “RG code”) that can then be used in other systems (IRB, SAGE, Epic EHR, Florence) to link all study records.

All clinical trials and clinical research studies that are expected to bill study participants, their health insurance, a study grant, or a study contract for clinical services, items or tests will undergo a CTO review in compliance with the UW Medicine COMP.202 policy. These studies will have a billing grid or a billing calendar created in OnCore CTMS and Epic EHR, which will be required to align with the study budget and the terms in the subject informed consent form and the study contract. This review will also provide current pricing for clinical items to inform the study budget and will set up the study for managing the post-award sponsor invoicing.

Consent form content

Consent forms for clinical trials must comply with the following requirements:

• Clearly identify any costs to the study participant or their insurance provider while participating in the study.
  Examples: If health insurance will be charged for trial-related procedures and items, will participants still be responsible for co-pays and deductibles? Is there clinical care that will occur at the same time as the research procedures but that are not part of the research – and for which participant’s health insurance will be asked to pay?
• Consistency among all active and approved study-related documents
  The information about who will pay for which study procedures, and about injury compensation, must be consistent among all such study documents, including, but not limited to, the protocol, grant award, contract, budget, payment terms, and consent form.
• Billing health insurance programs
  Study documents must not contain any language (including participant injury) that implies that a study participant or their health insurance program (government-funded or private) be charged first and the study sponsor pay the remaining balance not covered by insurance. Such language may implicate federal laws (e.g., Medicare Secondary Payer provisions) and could result in a False Claims Act violation by UW Medicine.
• Information about ClinicalTrials.gov registration
  The consent form must include a specific statement about the ClinicalTrials.gov registration if the trial is required to be registered. By regulation, the wording of the sentence cannot be changed. It is included in the UW consent templates.

Consent form repository

Federally supported clinical trials must post one IRB-approved version of an unsigned copy of the study consent form that was been used to enroll participants to a publicly available federal website. The consent form must be posted after the study is closed to recruitment and no later than 60 days after the last study visit by any participant, as required by the protocol.

There are two options for where to post the consent form. The researcher can choose either option.

1. ClinicalTrials.gov
   This may be the easiest choice if you have already registered your clinical trial at ClinicalTrials.gov. Specific instructions on how to register and upload documents (including consent forms) are available on the webpage ClinicalTrials.gov Entering Initial Results and Uploading Study Documents. If you have already registered your trial, read Appendix A.1 of the ClinicalTrials.gov Results Data Elements Definitions document for further information on posting consent forms.
2. Regulations.gov
   See the related instructions on OHRP’s Uploading a Clinical Trial Informed Consent form to Regulations.gov webpage.

Additional tips regarding posting consent forms

• When uploading consent forms, add a coversheet to each document that includes: study title, NCT number, PI name, document name, and IRB approval date. The footers on the IRB consent forms (and protocols) reflect the IRB’s template version dates, not the IRB approval dates.
• If your study has assent and/or parental permission forms. You are required to post only one form. If your study has a consent form, assent form, and parental permission form, you can choose which one to post.
• If your consent form is revised during the study. You do not need to replace an already-posted consent form with the revised version, though you can voluntarily choose to do so.
• If your study has a separate HIPAA authorization form. Do not post HIPAA authorization forms.

Data and Safety Monitoring Plan

A Data and Safety Monitoring Plan (DSMP) is required for all clinical trials. Industry sponsors typically build these into the study protocol. For non-industry trials, the PI or trial management group is responsible for developing and implementing a DSMP. View the UW ITHS website for information, tools, and templates.

Training

The principal investigator and other relevant members of the study team must fulfill training requirements before conducting a clinical trial that is funded by a federal agency and/or that is subject to FDA regulations. The requirements include:

• One-time completion of training about human subjects research and protections
• Completion of Good Clinical Practice (GCP) training once, followed by a refresher every 3 years

HSD provides access to training that meets these requirements on HSD’s Required Training webpage.

Additional information and resources

How to register, update, and report trial results

HSD has developed and obtained guidance, tools, and helpful information to assist researchers in meeting these requirements. See our related webpages:

• How to Register a Trial on ClinicalTrials.gov
• How to Update a Record or Report Results in ClinicalTrials.gov

Administrator of UW’s PRS group account

The UW’s PRS account at the ClinicalTrials.gov site is managed by HSD’s Regulatory Affairs team. This means that, in addition to completing the ClinicalTrials.gov assessment and pre-registering the study (as described above), HSD:

• Manages creation of UW user accounts at the ClinicalTrials.gov site
• Assists PIs in identifying resources to help resolve problems
• Assist with general questions

Administrator of UW studies managed by the Fred Hutchinson Cancer Consortium (FHCC)

The Cancer Consortium Clinical Research Support (CRS) Office assists with registration on ClinicalTrials.gov, as well as subsequent record updates and results reporting questions, for studies reviewed by FHCC’s IRB and where the PI is a member of the Cancer Consortium. CRS CT.gov results reporting policies can be found here. For questions related to studies managed by the CRS office, contact CTgov@fredhutch.org

Tracking registration and results reporting

HSD will track whether clinical trials under the UW PRS account have been registered and results are reported on CT.gov. UW IRB approval will not be renewed until registration has occurred.

Communication

HSD will communicate any changes or new information about these requirements through our monthly eNewsletter.

Questions and answers

Additional specific information is provided in HSD’s FAQ page. You can also email hsdreprt@uw.edu with questions.

Other assistance with clinical trials

The UW’s Institute for Translational Health Sciences can provide a wide variety of services and tools to assist with all aspects of a clinical trial. This includes regulatory coordinators and clinical study coordinators, available on an hourly or FTE contracted basis.

Version Information

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Keywords: CT.gov; Regulatory Affairs