ClinicalTrials.Gov

Tulane University School of Medicine
ClinicalTrials.Gov Program

Maintained by the National Library of Medicine (NLM) at the National Institutes Of Health (NIH), the clinicaltrials.gov website provides the public with access to information on publicly and privately funded clinical research studies.  Federal law, some journal publication standards, and some funders require registration of clinical trials and even some clinical studies on clinicaltrials.gov.

Why register with ClinicalTrials.Gov?

• Besides avoiding the potential loss of NIH funding, federally imposed penalties of $12,103 per day, and inability to publish, investigator compliance with clinicaltrials.gov promotes research transparency and scientific integrity. By posting results from all trials, not just published findings, investigators provide guidance for future research and augment the existing evidence base.

Do I need to register my study?

• If the study involves human participants prospectively assigned to one or more interventions to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes AND was initiated or completed on or after January 18, 2017, you likely will have to register.
  • NIH-funded studies follow the NIH definition of a clinical trial
  • The definition of an Applicable Clinical Trial (ACT) follows FDA Amendments Act and 42 CFR Part 11
    • This handy checklist can help evaluate whether or not you have an ACT
• If you want to publish the research in a medical journal, you will likely have to register
  • The International Committee of Medical Journal Editors (ICMJE) sets the publishing guidelines for most medical journals and requires studies to be registered with clinicaltrials.gov PRIOR to enrolling subjects.
• If you are unsure about registration, please contact Wesal Abualkhair, the person responsible for managing School of Medicine ClinicalTrials.Gov submissions, by phone 504-988-6200, or by email wabualkh@tulane.edu.

I will have to register the study, what is the next step?

• The TCCR is here to assist all Tulane University School of Medicine investigators navigating the registration and results reporting process.

• The first step in registering your study is to apply for a Protocol Registration System (PRS) account on clinicaltrials.gov.

I now have a PRS account and am ready to register the study.

• Excellent! Contact Wesal Abualkhair!

I am currently registered with clinicaltrials.gov, what is the next step?

• Here’s a quick overview on how to keep your study registration up-to-date:

What do I need to update?

More frequent updating is required for several data elements to help ensure that users of ClinicalTrials.gov have access to accurate, up-to-date information about important aspects of an applicable clinical trial or other clinical trial.

The following data elements must be updated no later than 30 calendar days after a change occurs:

• Study start date
• Intervention name(s)
• Availability of Expanded Access
• Expanded Access status
• Overall recruitment status
• Explanation for change in status
• Actual enrollment data
• Individual site status
• IRB status
• Completion Date
• Responsible Party
• Official Title
• Contact Information

When do I report results?

Results for the primary outcome measure are due within 12 months of the Primary Completion Date. All remaining results must be reported within 12 months of the Study Completion Date.

• Estimated time to enter results: up to 40 hours (depends on proficiency and quality of data sets available)
• It may take multiple review cycles to post your results
• The full protocol (or redacted version) along with the statistical analysis plan is required to be uploaded at the time of results reporting.

Primary Completion Date: the date that the last data point for the primary outcome measure was collected from the last enrolled participant.

Study Completion Date: the date that the last data point for all remaining outcome measures was collected from the last enrolled participant.

Do I need to post an informed consent form?

• If the clinical trial began or ended on or after January 21, 2019, then read below.

  

   

How can the TCCR assist me?

• Support for Tulane University School of Medicine investigators is provided free of charge through Tulane Center for Clinical Research. Contact Wesal Abualkhair.

   

  Thank you for your dedication to research and keep up the good work!