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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 and, in some cases, the posting of trial results.

As part of the WCM Human Research Protections Program, the ClinicalTrials.gov program aims to provide researchers with assistance in fulfilling the scientific, regulatory, and ethical responsibilities associated with publicly registering and posting trial results on ClinicalTrials.gov.

In fulfilling this role, Human Research Compliance provides:

  • Notices to PIs when public registration and posting of trial results is required.
  • Comprehensive internal QC review of all records.
  • ClinicalTrials.gov trainings and help sessions, regularly scheduled and on-demand for individuals or groups.
  • Biostatistician entry of statistical analyses into results records.
  • A variety of tools and guidances to assist in the registration and results entry processes.
  • Tracking of departmental compliance with ClinicalTrials.gov requirements.

You are invited to contact our office with requests for a help session, training or assistance.

Quarterly Training Available

Join us via Zoom session for one of our upcoming quarterly training dates conducted on Thursdays from 1:30pm - 3pm. We'll cover ClinicalTrials.gov regulatory requirements and practical, nuts and bolts information about how you can successfully register your trial, maintain your public record, and post results:

  • August 4, 2022
  • November 3, 2022

Email our office for the registration and password link.

To view a past training, please visit our Educational Resources page

ClinicalTrials.gov Guidelines & Policies

Guidelines



Frequently Asked Questions

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 and, in some cases, the posting of trial results.

How Do I Set Up My Account?

Principal Investigators must register their own studies in the Protocol Registration & Results System (PRS) at http://register.clinicaltrials.gov.  

To obtain a user account or to appoint a designee to maintain the ClinicalTrials.gov record on their behalf, Principal Investigators must complete the following: 

1. Send an email requesting an account to registerclinicaltrials@med.cornell.edu

      • In the subject line type: "CT.gov Account Request"
      • In the body of the email provide the following information: 

CWID
Phone Number:
IRB Protocol# (of trial being registered)

If you need access to all of your PI’s trials in the PRS please list their name(s) here: [list names]

Please note that only Principal Investigators can appoint their own designee(s) and a designee must have a WCM email address to qualify for a user account.

2. You will receive an email within 48 hours of your request with your login name and temporary password

3. Log into the PRS system using your login name and temporary password

4. Navigate to the ‘Accounts’ tab and select “Change Password” to replace your temporary password with something you can remember

How do I complete the registration process?

Use the following guidance documents, available for download in the Guidelines portion of the Policies and Forms section above:

Remember that:

  • ClinicalTrials.gov QC Criteria should be followed.
  • The registration is not submitted for internal QC review until the user clicks "Entry Complete" in the system.

Help sessions via Zoom are available upon request.

Which trials should be registered on ClinicalTrials.gov?

Interventional investigator-initiated trials sponsored by WCM must register.  We have a decision tool available to assist in the determination of whether your trials needs to be registered on ClinicalTrials.gov; in general, the following clinical trials must be registered:

  • Applicable Clinical Trials (ACTs) - clinical trials of FDA-regulated products (drugs, devices, or biologics), as long as the trial is neither a feasibility study of a device prototype nor a phase 1 study of a drug. (Phase 1 studies usually evaluate safety, maximally tolerated dose, pharmacokinetics, etc.). To determine if your study is an ACT, click here.
  • NIH-funded clinical trials – all clinical trials funded by NIH, wholly or in part, require registration and results reporting if the grant application was received by NIH on or after Jan. 18, 2017. Click here to determine if your study meets NIH's definition of a clinical trial.
  • Clinical trials being considered for publication in ICMJE-affiliated journals must be registered on ClinicalTrials.gov before the first participant is enrolled.For more information on the International Committee of Medical Journal Editors’ (ICMJE) publication requirements, click here.  
  • PCORI-funded patient registries and clinical studies must be registered on ClinicalTrials.gov. For more information on Patient-Centered Outcomes Research Institute (PCORI) requirements for registration, click here.
  • Your funding agency may have its own requirements; be sure to check the terms of your award letter.

When should I register on ClinicalTrials.gov?

It is WCM policy and a condition of publication in ICMJE journals that studies are fully registered (i.e., an NCT # is obtained) prior to enrollment of the first participant. You can begin the registration process once you have a completed IRB protocol application and protocol document. You do not need IRB approval to initiate the registration process on ClinicalTrials.gov.

How long does it take to register a study on ClinicalTrials.gov?

Internal quality control (QC) review of a ClinicalTrials.gov registration record is a collaborative process between our office and the study team that can take approximately 2 weeks, depending in part on how quickly the study team resolves internally identified QC issues and whether a Zoom help session is needed.

Once the record is released to ClinicalTrials.gov, the ClinicalTrials.gov QC review typically takes 2 to 5 days. If the QC review identifies issues requiring further edits by the study team, the record will undergo another internal QC review before being re-reviewed by ClinicalTrials.gov according to the same timelines.

Who is responsible for registering a clinical trial?

The Responsible Party is responsible for ensuring the trial is registered and for promptly making updates as required by all applicable regulations and policies. Provided certain stipulations have been met, WCM designates the main Principal Investigator (PI) as the Responsible Party for the following clinical trials:

1.     Trials in which the PI holds the IND/IDE (the PI is also considered the sponsor-investigator).

2.     Trials initiated by the Principal Investigator.

3.     NIH-sponsored trials for which WCM is the grantee institution.

4.     Trials, initiated by private industry or other outside entities, for which the Principal Investigator accepts the role of the Responsible Party in an explicit agreement.

What does posting to ClinicalTrials.gov achieve?

As outlined in the Declaration of Helsinki, researchers, authors, and sponsors have an ethical obligation to publish and disseminate research results, whether positive, negative, or inconclusive. As outlined by the ICMJE and ClinicalTrials.gov, registering your trial and posting results serves 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.

Do I need to update my ClinicalTrials.gov study record?

ClinicalTrials.gov study records must be updated at least once per year. Additional, more rapid updates are required according to the table available here.

How do I enter trial results on ClinicalTrials.gov?

The following resources are available to you:

For instructions on uploading your protocol and statistical analysis plan, refer to the guidance available below.

Help sessions via Zoom are available upon request.

What do I do if I'm a Principal Investigator leaving WCM?

Contact our office as soon as possible so we can work with you to either update and finalize your public records or, if applicable, transfer them to your new institution.

Helpful Resources

Questions about ClinicalTrials.gov?

Contact the ClinicalTrials.gov Office:

646-962-8200
registerclinicaltrials@med.cornell.edu

Lauren Odynocki
Senior Human Research Compliance Specialist
ClinicalTrials.gov Administrator
Reportable Events Administrator

Lauren Blumberg
Assistant Director, Regulatory Compliance