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ClinicalTrials.gov Registration & Results Reporting

The following guide is designed to help you navigate the ClinicalTrials.gov (i.e., PRS system) registration process. If you have any questions about the process of submitting information to ClinicalTrials.gov, please contact registerclinicaltrials@med.cornell.edu.

What is ClinicalTrials.gov?

  • ClinicalTrials.gov is a service of the U.S. National Institutes of Health that acts as a registry and results database of publicly and privately supported clinical studies of human participants. The Department of Health and Human Services (HHS), the Food and Drug Administration, the National Institutes of Health (NIH), and the International Committee of Medical Journal Editors (ICMJE) all require the public registration of clinical trials.

Why should researchers post to ClinicalTrials.gov?

  • • In harmony with the Declaration of Helsinki, researchers, authors, and sponsors have an ethical obligation to publish and disseminate research results, whether positive, negative, or inconclusive.

    • Consistent with the ICMJE and ClinicalTrials.gov, Weill Cornell Medicine posts to:

      ○ help patients and the public know what trials are planned or ongoing into which they might want to enroll
      ○ prevent selective publication and selective reporting of research outcomes
      ○ prevent unnecessary duplication of research effort
      ○ help give ethics review boards considering approval of new studies a view of similar work and data relevant to the research they are considering.
      ○ help editors and others understand the context of study results
      ○ promote more efficient allocation of research funds 

Which research studies need to be listed on ClinicalTrials.gov?

  • Differing and overlapping requirements are stipulated by several organizations and regulatory bodies. That is, the International Committee of Medical Journal Editors (ICMJE), HHS, and the NIH.
    If your trial meets any of these requirements, it must be registered on ClinicalTrials.gov:  

    • The International Committee of Medical Journal Editors (ICMJE), requires the public registration of: “any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes" Registration is required as a condition of consideration for publication. Given that, WCM and ICMJE recommend that those who are uncertain of whether their trial requires posting should err on the side of registration if they wish to seek publication in an ICMJE journal. Please note that observational studies need not be posted. 

    • Health and Human Services (HHS), under the Final Rule, requires the public registration of clinical trials involving FDA-regulated products (excluding phase 1 trials or small feasibility device studies) Use the tool at https://prsinfo.clinicaltrials.gov/ACT_Checklist.pdf to determine if you need to post according to the HHS Final Rule. 

    • National Institutes of Health (NIH) Policy requires the public registration of all clinical trials funded wholly or partially by NIH. To determine whether your NIH funded study is required to be posted to ClinicalTrials.gov, ask the following: 

       1.   Does the study involve human participants?
       2.   Are the participants prospectively assigned to an intervention?
       3.   Is the study designed to evaluate the effect of the intervention on the participants?
       4.   Is the effect of being evaluated a health-related biomedical or behavioral outcome?

        If the answers are all “yes,” then the study is a clinical trial that needs to be posted.
        If any answers are “no,” the study is not a clinical trial that needs to be posted. 

    Use our decision tool, available here, in order to determine whether your trial needs to be posted to ClinicalTrials.gov.
    Survey responses will be anonymously recorded to assess how often the research community is making use of this resource.

    Quick Guide



    Please note that, if this is a multi-center trial that is sponsored by another entity (e.g., non-NIH government funded, pharmaceutical, etc.,) then that entity is responsible for creating the ClinicalTrials.gov record, with Weill Cornell listed as a sub-site under their main ClinicalTrials.gov record.  

    The differing and overlapping requirements are also stipulated by:
    • The World Health Organization (WHO)
    • The FDA via Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA)
    • The Declaration of Helsinki.

    While the vast majority of studies fall under the ICMJE requirement, please contact registerclinicaltrials@med.cornell.edu if you are unsure of whether or not your study needs to be registered. Certain observational studies, and studies that enroll health care providers as subjects may not need to be registered.

When should I register my study?

  • WCM policy requires that registration occur prior to enrollment of the first subject. 

    You can initiate registration of studies even if IRB approval has not been obtained as long as the study has an IRB protocol number, which is issued to Principal Investigators upon completing Part A of the Clinical Study Evaluation Committee (CSEC) application.

How can I log in to begin registering my study?

  • WCM policy requires that Principal Investigators must be the owner of a given ClinicalTrials.gov record, or formally appoint a designee. This means each PI must email registerclinicaltrials@med.cornell.edu to either obtain his or her own user account by providing name, email, CWID, and phone number to the WCM ClinicalTrials.gov Administrator, or stating the name and information of a designee so a user account can be provided for that person instead.

What if I forget my username and password?

How do I complete the “Protocol Section” of the record?

  • Each component of the Protocol Section is referred to as a “protocol module.” PRS has created a guide on how to complete each module, including notes on what PRS will look for when evaluating that particular module. PRS has also created precise explanations for each question within the protocol modules so that it’s clear what each field is requesting. Lastly, PRS has created a brief document that goes into greater detail concerning PRS requirements. Pay attention to these notes and details to help expedite authorization of the public release of your record.
    WCM has also made available a step-by-step resource at the bottom of this website in the "Downloads" section called the ClinicalTrials.gov PRS Registration User Guide. Please download this document for step-by-step guidance with screenshots.

    As you complete the section, errors, warnings, alerts, or notes may appear.
    • Error – Messages that indicate serious problems that need to be addressed
    • Warning – Messages that indicate items that are (or may be) required by FDAAA 801
    • Alert – Messages that indicate problems that need to be addressed
    • Note – Messages indicating potential problems that should be reviewed and corrected as needed.

    Each needs to be resolved prior to completing the record. Records with unresolved errors, warnings, alerts, or notes may not be submitted by WCM for PRS review.

    Please be aware that, when prompted to provide a “Unique Protocol ID” by the PRS system, the IRB protocol number must be used. 

    Lastly, it is important to note data sharing statement requirements now in place as a condition of publication in ICMJE journals. Please scroll to the "Downloads" section of this website to download the ClinicalTrials.gov Data Sharing Plan Info Sheet for information on how to complete your protocol registration so that it complies with this requirement. 

How do I submit my record for posting to ClinicalTrials.gov?

  • Click “Entry Complete” within your PRS record to notify the Weill Cornell ClinicalTrials.gov Administrator that your record is ready for release to PRS for evaluation. The Weill Cornell ClinicalTrials.gov Administrator will be automatically notified and will typically approve and release the record within 1 business day. (There will be a delay only if there are any errors, warnings, alerts, or notes still present in your record. The Weill Cornell ClinicalTrials.gov Administrator will contact you with a request that you resolve these items so that the process can move forward.) 

How long will it take for PRS to review my submission?

  • PRS takes 2 to 5 business days to review a submission that doesn’t have results. If the submission has results, the review may take up to 30 days. 

What is an NCT number and when is it issued by PRS?

  • The NCT Number, also called the ClinicalTrials.gov Identifier or National Clinical Trial Identifier, is assigned after the Weill Cornell ClinicalTrials.gov Administrator has released your protocol record to PRS for review, all PRS review questions have been resolved, and the record is publicly released by PRS. 

How do I complete the “Results Section” of the record?

  • The Results Section is made up of 4 separate modules: (1) Participant Flow, (2) Baseline Characteristics, (3) Outcome Measures and Statistical Analyses, and (4) Adverse Events. Information on how to complete each module is available here. Descriptions of precisely what each question is asking within each module are here. PRS also provides a document with helpful tips.

    Additionally, ClinicalTrials.gov makes available example study records and study papers to illustrate key concepts for results data entry in PRS. 
      ○ Parallel Study Design: Example ClinicalTrials.gov record and fictional table and figures
      ○ Cross-over Study Design: Example ClinicalTrials.gov record and fictional manuscript
      ○ Dose Escalation Study Design: Example ClinicalTrials.gov record and fictional manuscript
      ○ Factorial Study Design: Example ClinicalTrials.gov record and fictional manuscript
      ○ Multiple Period Study Design: Example ClinicalTrials.gov record and fictional manuscript

    As you complete the section, errors, warnings, alerts, or notes may appear. 
    • Error – Messages that indicate serious problems that need to be addressed
    • Warning – Messages that indicate items that are (or may be) required by FDAAA 
    801 • Alert – Messages that indicate problems that need to be addressed
    • Note – Messages indicating potential problems that should be reviewed and corrected as needed.

    Each needs to be resolved prior to completing the record. Records with unresolved errors, warnings, alerts, or notes may not be submitted by WCM for PRS review. 

How do I complete the “Results Section” of the record if the trial was terminated?

  • If the trial was terminated and no data was collected for one or more outcome measures, then set the “Overall Recruitment Status” to “Withdrawn.” No further 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” in each Arm/Group, and leave the data fields blank. In this case, 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, submit the available data for the enrolled participants in the Participant Flow, Baseline Characteristics, and Adverse Events modules. 

When does my record need to be updated?



  • If needed, you can check previous versions of your record by entering the NCT number for a given record at the ct.gov archives site https://clinicaltrials.gov/archive/. The NCT number is the number that PRS assigned to the record upon its public release. It begins with “NCT.” (E.g., NCT12345678) When you’re in the study record, the number is next to the word, “Identifiers.” 

How do I update my record?

  • Log into register.clinicaltrials.gov, click on “Modify,” then “Edit” to open the study. Make changes as needed. If no changes have occurred in the last 12 months, update the Record Verification Date by clicking the “Edit” button next to the field. Then click “Complete” to notify the Weill Cornell ClinicalTrials.gov Administrator your record’s update is ready for release to PRS. 

Who is responsible for creating and updating my record?

  • WCM policy indicates that Principal Investigators are responsible for registering and maintaining clinical trials. The Principal Investigator is delegated the Responsible Party role and assumes the associated responsibilities on a WCM investigator-initiated trial. 

    The Responsible Party means one of the following: 
    1) The sponsor of the clinical trial (as defined in 21VFR50.3€ (e.g., IND/IDE holder or person who initiated the trial (funding recipient if grant or sponsored research agreement; funder if procurement funding agreement/contract)) or 
    2) The PI of such a clinical trial, if so designated by the sponsor, grantee, contractor, or awardee, that meets all of the following conditions: 
    a. The PI is responsible for conducting the trial
    b. The PI has access to and control over the data from the clinical trial 
    c. The PI has the right to publish the results of the trial 
    d. The PI has the ability to meet all of the FDAAA’s requirements for the submission of clinical trial information. 

How do I transfer ownership of a record to a sponsor or another institution?

  • Please email registerclinicaltrials@med.cornell.edu with your request and provide the following:
    • ClinicalTrials.gov Identifier – This is the number that PRS assigned to the record upon its public release. It begins with “NCT.” (E.g., NCT12345678) When you’re in the study record, the number is next to the word, “Identifiers.”
    • Organization Username – This is the username that your new organization uses to log into its own PRS account. For example, Weill Cornell’s organizational username is WeillMC.
    • Individual Username – This is the username of the person who will be managing that particular record at the new organization.
    • Grant Number – This number is only required if the study is NIH funded. 

    The WCM ClinicalTrial.gov Administrator will then submit your request to PRS. Turnaround time for the transfer of a record is typically within 24 hours. 

Who can I contact if I have questions?

Downloads
WCM ClinicalTrials.gov PolicyPDF
ClinicalTrials.gov Dissemination Plan Language for NIH FORM EMicrosoft Word
ClinicalTrials.gov PRS Registration User GuidePDF
ClinicalTrials.gov Data Sharing Plan Info SheetPDF