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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:
You are invited to contact our office with requests for a help session, training or assistance.
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:
Email our office for the registration and password link.
To view a past training, please visit our Educational Resources page
PRS Registration User GuideClinicalTrials.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.
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
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
Use the following guidance documents, available for download in the Guidelines portion of the Policies and Forms section above:
Remember that:
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:
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.
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:
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:
For instructions on uploading your protocol and statistical analysis plan, refer to the guidance available below.
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.
