•  WCM ClinicalTrials.gov Protocol and SAP Upload and Redaction Guidance
  Instructions on how to prepare your protocol document and statistical anlysis plan for upload on ClinicalTrials.gov at the time of results entry.
•  Requirements for Posting
  Institutional requirements for every registration record.
•  Data Sharing Plan Info Sheet
  Guidance on how to meet the ICMJE's data sharing requirement, which is a condition of publication.
•  PRS Registration User Guide
  A step-by-step guidance with screenshots

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.

For non-cancer studies, 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 of non-cancer studies 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 for the intended designee(s): 

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

If the designee needs access to all of the PI’s trials in the PRS please list all applicable protocol #s.

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. The designee(s) will receive an email within 48 hours of the request with login name and temporary password

3. The designee(s) must log into the PRS system using their login name and temporary password

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

For cancer studies, the Program Managers for each disease area in the Cancer Clinical Trials Office (CCTO) will register and maintain ClinicalTrials.gov records as designee(s) of the Principal Investigator.

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.

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.

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 in WRG-HS. You do not need IRB approval to initiate the registration process 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.

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.

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.

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

The following resources are available to you:

• Information on how to complete each of the 4 results modules.
• Descriptions of precisely what each data field requires.
• Examples for how to complete data entry for different study types.
• ClinicalTrials.gov's Results QC Criteria

For instructions on uploading your protocol and statistical analysis plan, refer to the guidance available in the "Guidelines" section above.

Help sessions via Zoom are available upon request.

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.

The revised Common Rule requires awardees of clinical trials funded by a Common Rule agency (NIH, AHRQ, etc.) that were IRB-approved on or after January 21, 2019 to publicly post one (blank) informed consent form, used to consent participants, to ClinicalTrials.gov.

Only forms posted (1) after a study is closed to recruitment, and (2) where 60 or fewer days have passed since the last study visit by any enrolled subject satisfy the regulatory requirement.

To ensure your study adheres to the posting timeline required by this regulation, be sure to update OnCore once your study is closed to accrual. Our office uses this status to know when to email you a reminder about posting the informed consent.

Still have questions? Contact registerclinicaltrials@med.cornell.edu.

• Checklist for Evaluating Whether a Clinical Trial or Study is an Applicable Clinical Trial (ACT)
• Protocol Registration and Results System
• Protocol Registration Quality Control Review Criteria
• Results Quality Control Review Criteria
• Regulations and Support Materials
• Tutorial on Outcome Measures and Statistical Analyses in the Results
• Tutorials on Registration and Results Reporting

• ICMJE Publication: Requirements for Registration

• NIH Requirements for Registering & Results Reporting