Clinical Research Support (CRS) provides expertise in federal regulations and policy that govern reporting requirements in ClinicalTrials.gov and the National Cancer Institute's Clinical Trials Reporting Program (CTRP). CRS staff work with Consortium investigators and their staff to ensure registration, accrual reporting, and record maintenance.
As members of an NCI-designated Comprehensive Cancer Center, Cancer Consortium investigators are responsible for maintaining compliance in ClinicalTrials.gov and CTRP.
Government agencies and the International Committee of Medical Journal Editors (ICMJE) have issued laws and directives on the subject of trial registration. All parties have consistently agreed that the purpose of trial registration is to promote the public good by ensuring that the existence and design of clinically directive trials are publicly available.
CTgov@fredhutch.org for assistance with ClinicalTrials.gov and FDAAA regulations
CTreporting@fredhutch.org for assistance with CTRP and NCI reporting requirements
Federal Registry Requirements
Frequently Asked Questions
|FDAAA 801||ICMJE||HHS - Final Rule||NIH Policy||NCI CTRP|
|Information needed||Registration and Results reporting (ClinicalTrials.gov)||Registration only (ClinicalTrials.gov)
||Registration and Results reporting (ClinicalTrials.gov)||Registration and Results reporting (ClinicalTrials.gov)
||Registration only (Cancer.gov)|
|Types of research||Drugs, biological products, and devices regulated by the FDA (not Phase 1)
||All phases and types of interventions
||Drugs, biological products, and devices regardless if approved, licensed or cleared by FDA (not Phase 1)||All phases and types of interventions, trials funded in whole or in part by NIH||All interventional and observational studies conducted in NCI-designated Cancer Centers|
|Effective as of||Applicable trials that have activated for accrual on or after 12/26/2007||N/A||Applicable trials that have a Primary Completion Date on or after 01/18/2017||Applicable trials that have activated for accrual on or after 01/18/2017||Interventional trials open to accrual as of or after 01/01/2009, observational studies open to accrual as of or after 01/01/2020|
|Penalties||Fines up to $10,000 per day (not including inflation) and/or loss of federal funding (Guidance Reference)||Refusal to publish||Fines up to $10,000 per day (not including inflation) and/or loss of federal funding (Guidance Reference)||Termination of grant funding||Risk to NCI CCSG funding|
CTRP: CRS will register all cancer-focused interventional trials and observational studies in CTRP following initial SRC and IRB approval, respectively. This includes Consortium participation in industry studies.
ClinicalTrials.gov: CRS will register cancer-focused investigator-initiated, interventional trials with ClinicalTrials.gov following initial SRC approval. Industry-sponsored trials and multi-center trials coordinated by another institution should be registered on ClinicalTrials.gov by the industry or institutional sponsor per 42 CFR 11.4(c)(1); however, the PI is ultimately responsible for determining that registration requirements are met.
If your non-oncology study is not registered by an outside sponsor and you need to register it, contact the CTgov Administrator for an individual ClinicalTrials.gov user account.
Studies need to be registered in ClinicalTrials.gov and CTRP prior to enrollment of the first participant to comply with ICMJE and NCI requirements.
Studies need to be updated at least once every 6 months. However, study records need to be updated within 30 days of any of the following:
- Change in site(s) or overall recruitment status
- Changes from protocol amendments impacting participants (within 20 days for CTRP)
- Change in Primary Completion Date or Study Completion Date
For studies maintained by CRS:
- Changes in recruitment statuses will be updated by CRS in accordance with updates made in OnCore CTMS
- Changes resulting from protocol amendments updated in OnCore CTMS will be sent to study teams for review before update
- CRS will conduct outreach every 6 months, at minimum, for data verification (including completion dates)
When a study is no longer enrolling participants, the site(s) and overall statuses must be updated within 30 days of the change. Additionally, the "actual" number of participants enrolled should be submitted at the time the primary completion date is changed to "actual".
For studies subject to the revised 2018 Common Rule, a copy of the informed consent used to enroll at least one participant must be uploaded to ClinicalTrials.gov after the study closes to accrual and no later than 60 days following the study completion date. When a study closes to accrual in OnCore, CRS will reach out to the study team to verify the current completion dates and whether the informed consent form needs to be uploaded in ClinicalTrials.gov.
Generally, studies that were approved by the IRB prior to January 21, 2019 are not subject to the new Common Rule requirements. However, that is not always true. Please use the following links to learn more about the Common Rule revisions and determine if they apply to your research:
If it has been more than ten months since the last participant was enrolled for a Consortium investigator-initiated, interventional trial, please contact the CTgov Administrator immediately.
A delayed results reporting extension may need to be submitted in ClinicalTrials.gov to avoid late results reporting if the study closes in the future without ever enrolling another participant. If applicable, this extension must be submitted before results would otherwise be due (within a year of the actual Primary Completion Date, based on enrolled participants). For example: if data was last collected from enrolled participants for the primary outcome measures on December 5, 2022, the extension request would need to be submitted BEFORE December 5, 2023.
Under FDA Amendments Act (FDAAA 801), certain studies are Applicable Clinical Trials (ACT), which means that they must report results in ClinicalTrials.gov within a year of the study’s actual Primary Completion Date. Here is the checklist for determining whether a study is an ACT.
However, even if a study is a non-ACT, results reporting in ClinicalTrials.gov may still be required if there is NIH funding. The NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information, effective January 18, 2017, requires ClinicalTrials.gov results reporting for all NIH-funded clinical studies, regardless of study phase, type of intervention, or whether they are subject to FDAAA 801. The NIH policy applies to applications for funding including for grants, other transactions, and contracts submitted on or after the policy's effective date that request support for the conduct of a clinical trial that is initiated on or after the policy's effective date.
|FDAAA 801||HHS - Final Rule||NIH Policy|
|Types of research||Drugs, biological products, and devices regulated by the FDA (not Phase 1)
||Drugs, biological products, and devices regardless if approved, licensed or cleared by FDA (not Phase 1)||All phases and types of interventions, trials funded in whole or in part by NIH|
|Effective as of||Applicable trials that have activated for accrual on or after 12/26/2007||Applicable trials that have a Primary Completion Date on or after 01/18/2017||Applicable trials that have activated for accrual on or after 01/18/2017|
Yes, results must still be reported in ClinicalTrials.gov if the study is subject to the FDAAA 801 and/or NIH policy, and at least one participant was enrolled. If no participants were ever enrolled in the trial, the overall recruitment status will be set to Withdrawn, and no further results information will need to be submitted.
For a trial that was terminated after participants were enrolled, any available data must be reported.
- If no data are available for any of the Outcome Measures, specify zero ("0") for the Number of Participants Analyzed in each Arm/Group, and provide an explanation in the Analysis Population Description for why zero participants were analyzed and, if appropriate, provide information in the Limitations and Caveats module.
- Even if data are not entered for Outcome Measures, data for enrolled participants must be submitted in the Participant Flow, Baseline Characteristics, and Adverse Events modules.
Summary results must be submitted within 12 months of the trial’s Primary and Study Completion Dates. The actual dates should be determined using the regulatory definitions below.
The completion dates are based solely on final data collection from participants for the items specified in the respective definitions. The completion dates are not affected by subsequent assessment, analysis, or interpretation of the data collected from participants. For example, if a participant was examined with a magnetic resonance imaging (MRI) scan for the primary outcome, the Primary Completion Date is the date that the last participant underwent the MRI, and not when the MRI was subsequently assessed using a central reading process or other review procedure.
The actual completion dates determine the deadlines for reporting certain results information in ClinicalTrials.gov, so it’s important to update the completion dates within 30 days of their respective occurrence. Please reach out to the CTgov Administrator as soon as possible whenever either completion date has occurred, so that the ClinicalTrials.gov record can be updated in a timely manner.
|Primary Completion Date||Study Completion Date|
|The date that the final participant was examined or received an intervention for the purposes of final collection of data for the primary outcome, whether the clinical study concluded according to the pre-specified protocol or was terminated. In the case of clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all of the primary outcomes.||The date the final participant was examined or received an intervention for purposes of final collection of data for the primary and secondary outcome measures and adverse events (for example, last participant’s last visit), whether the clinical study concluded according to the pre-specified protocol or was terminated.|
Failure to comply with FDAAA 801 requirements may result in financial penalties of up to $10,000 per day, withholding of funds, and sanctions imposed by the FDA. The Federal Food, Drug, and Cosmetic Act caps monetary penalties, permitting a maximum penalty of $10,000 for all violations adjudicated within a single proceeding, or, if a Responsible Party fails to remedy its noncompliance within the notice period, $10,000 per day of continuing noncompliance (detailed in FDA final guidance on Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank). These amounts may be updated to reflect inflation in accordance with federal law. Inflation-adjusted maximums are found at 45 CFR 102.3.
Failure to comply with NIH policy may result in withholding of cash payments, disallowing cost for an activity, suspending or terminating either in part or whole the current award, withholding a future award, and having a non-compliance notice publicly available.
NIH Grantee Requirements for Registering & Reporting NIH-funded Clinical Trials in ClinicalTrials.gov
NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information
FDA Amendments Act (FDAAA 801) & the Final Rule Registration and Results Requirements
ClinicalTrials.gov Registration and Results Reporting Guided Tutorials
ClinicalTrials.gov Interventional Study Protocol Registration Template
How to Submit Study Results and Adverse Events on ClinicalTrials.gov
Checklist for Evaluating Whether a Clinical Trial or Study is an Applicable Clinical Trial (ACT)
ClinicalTrials.gov Support Materials
ICMJE Information (Medical Journal Publishing Requirements)
HHS Final Rule News Release (September 16, 2016)
Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank (August 2020, FDA Final Guidance)