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Research

ClinicalTrials.gov

Index

Introduction

Policies and Forms

FAQs

Announcements

Introduction

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.

Policies and Forms

Guidelines

Policies

FAQs

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.

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.

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

Interventional investigator-initiated trials sponsored by Weill Cornell Medicine must register. 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.)

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 do I obtain an account in order to register?

Principal Investigators must register their own studies in the PRS (Protocol Registration & Results System) 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 email our office with CWID and phone number of whomever needs access along with the applicable IRB protocol number.

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.

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:

  • ClinicalTrials.gov PRS Registration User Guide - A step-by-step guidance with screenshots.
  • Data Sharing Plan Info Sheet - Guidance on how to meet the ICMJE's data sharing requirement, which is a condition of publication.
  • Requirements for Posting - Institutional requirements for every registration record.

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.

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

Internal 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.

When 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 in the Policies and Forms section above.

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.

Announcements

Quarterly Training Now Offerred

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:

  • May 5, 2022
  • August 4, 2022
  • November 3, 2022

Email our office for the registration and password link.

Office Contacts

Lauren Odynocki
Senior Human Research Compliance Specialist
Phone:
646-962-4065
Email: registerclinicaltrials@med.cornell.edu
Lauren Blumberg
Assistant Director, Regulatory Compliance
Phone:
646-962-8200
Email: registerclinicaltrials@med.cornell.edu
Melissa Epstein
Executive Director, Human Research Protections and Compliance
Phone:
646-962-8200
Email: registerclinicaltrials@med.cornell.edu