The following guide is designed to help you navigate the ClinicalTrials.gov (i.e., PRS system) registration and results reporting process. If you have any ClinicalTrials.gov questions, or to request a tailored training, please contact firstname.lastname@example.org.
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. 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.
- 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.
Contact email@example.com 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. This is also a condition of publication in ICMJE journals.
How can I log in to begin registering my study?
If you are a Principal Investigator: email firstname.lastname@example.org with your phone number to obtain a user account.
If you will be maintaining the record on behalf of a Principal Investigator: The Principal Investigator needs to email email@example.com to provide IRB protocol # together with the name, email, CWID, and phone number of any intended designee(s).
What if I forget my username and password?
How do I complete the “Protocol Section” of the record?
In the "Downloads" section, see WCM's step-by-step resource with screenshots called the ClinicalTrials.gov PRS Registration User Guide.
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 (i.e., ClinicalTrials.gov) review.
Note the data sharing statement requirements now in place as a condition of publication in ICMJE journals by viewing the ClinicalTrials.gov Data Sharing Plan Info Sheet in the "Downloads" section.
In-person training and guidance is available upon request. Email firstname.lastname@example.org.
How do I submit my record for posting to ClinicalTrials.gov?
Click “Entry Complete” within your PRS record to notify the WCM ClinicalTrials.gov Administrator that your record is ready for release. The WCM ClinicalTrials.gov Administrator will be automatically notified and will typically approve and release the record within 2 business days. (There will be a delay only if there are any errors, warnings, alerts, or notes still present in your record. The WCM 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 WCM ClinicalTrials.gov Administrator has released your protocol record to PRS for review, all major PRS issues 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
Please note that 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 public versions of your record by entering the NCT number for a given record at the ClinicalTrials.gov archives site https://clinicaltrials.gov/archive/.
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 in the "Study Status" section by clicking the “Edit” button next to the field. Then click “Entry Complete” to notify the WCM ClinicalTrials.gov Administrator your record’s update is ready for release to PRS.
Who is responsible for creating and updating my record?
Principal Investigators are responsible for registering and maintaining the record for their clinical trial. 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:
- 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
- The PI of such a clinical trial, if so designated by the sponsor, grantee, contractor, or awardee, that meets all of the following conditions:
- The PI is responsible for conducting the trial
- The PI has access to and control over the data from the clinical trial
- The PI has the right to publish the results of the trial
- 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 email@example.com with your request and provide the following:
• ClinicalTrials.gov Identifier/NCT #
• 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 want tailored individual or group training at my location?