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FAQ ABOUT CLINICAL TRIALS REGISTRY

 

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What is ClinicalTrials.gov?
A directory of federally and privately supported research trials conducted in the USA and around the world to test the effect of experimental drugs, devices, and procedures for many diseases and conditions. Each entry includes a summary of the trial protocol, including the purpose, recruitment status, and criteria for patient participation, Trial locations and specific contact information are provided to assist enrollment.

 

Why do I need to register my study with ClinicalTrials.gov?
  1. Federally mandated in the Food and Drug Administration Modernization Act (FDAMA) section 113 which required NIH to establish, maintain, and operate a public resource for information on efficacy studies of drugs, including biological drug products, to treat serious or life-threatening diseases and conditions conducted under the FDA’s investigational new drug (IND) regulations (21 CFR parts 312 and 812).
  2. Required by the International Committee of Medical Journal Editors (ICMJE) as a condition for publication.
  3. NIH commitment to provide information to increase public awareness and access to clinical trials sponsored federally and by industry or foundations.

 

Which studies should be registered?
  1. Clinical Trials that are approved by a human subject review board
  2. Clinical Trials that conform to the regulations of the appropriate national health authorities

Both interventional and observational trials are accepted. In addition NIH encourages (and the AAMC concurs) registration of all trials, regardless of whether required under applicable law.UNMC IRB has established a new policy requiring the registry of all Clinical Trials on ClinicalTrials.gov. 

 

What happens if I do not register my study in Clinicaltrials.gov?
  • You will be in violation of UNMC IRB policy and subject to sanctions.
  • You will not be able to publish your results in most of the major journals
  • You may be subject to substantial fines
    • Maximum fine levied is $310, 000 per trial
    • Calculations based on $10, 000 for each trial not registered plus an additional $10, 000 per day (up to 30 days) that it takes to bring trial into compliance.

 

Who may submit a study to ClinicalTrials.gov?
  1. Sponsors legally responsible for conducting clinical trials.
  2. Government or International agencies conducting or supporting clinical trials.
  3. Lead Principal Investigators (LPI) responsible for conducting and coordinating overall clinical investigation. For Multi-site studies, submission of data should be coordinated amongst the sites so that the study is listed only once in ClinicalTrials.gov. 

 

Is there a charge for listing my studies in ClinicalTrials.gov?
NO ClinicalTrials.gov is a free service of the NIH, provided through it’s National Library of Medicine (NLM)

 

Do my studies have to be approved by IRB before I enter them into ClinicalTrials.gov?
NO You may register your study in ClinicalTrials.gov prior to getting approval from your human subjects review board (i.e., IRB or Ethics Committee), provided the study is not yet recruiting. Before the 1st patient is recruited, board approval must be obtained and the protocol record in clinicaltrials.gov must be updated accordingly.

 

How do I register my study?
Contact the Protocol Registration System (PRS) Administrator located in the Office of Regulatory Affairs, phone number 559-3853, for assistance. The PRS administrator will set up accounts for new users and assist previous users who have forgotten logins and/or passwords.

 

Who is responsible for maintaining the data in ClinicalTrials.gov?
  1. The Sponsor or LPI will enter information about their studies, ensuring that the information is correct and readily understood by the public.
  2. The PRS Administrator has overall responsibility to ensure that the organization’s records are verified, updated, and re-released as needed, or at least every six months. They serve as a point of contact for the ClinicalTrials.gov team and resolve questions associated with the information that is provided.
  3. It is the responsibility of the Sponsor or LPI to provide corrections and/or updates to the PRS Administrator in a timely manner.

 

Can protocol information be transferred to ClinicalTrials.gov electronically?
YES This option is available in the PRS as an HTTP upload of an XML formatted file.

 

Can the results of a study be listed on ClinicalTrials.gov?
YES You are encouraged to list citations to peer-reviewed publications that include results from the clinical trials. You may provide the unique PubMed Identifier (PMID) of an article, enter the full bibliographic citation using the PRS, and/or post a link to your own website provided that it clearly identifies your organization. In addition, ClinicalTrials.gov encourages you to provide a link to the appropriate approved drug page at FDA’s Drugs@FDA website:  http://www.accessdata.fda.gov/scripts/cder/drugsatfda

 

We have our own Registry, can our information be transferred to Clinical Trials.gov, instead of entering it again?
YES If your registry is a single sponsor registry, you will:
  1. apply for an organizational account with ClinicalTrials.gov
  2. Format your data in n the XML structure
  3.  Upload as an HTTP upload to the data entry site  

You may only provide data on studies for which your organization is the lead sponsor. 

 

What do we do if we have data from studies with multiple sponsors?
Send email to mailto:Register@clinicaltrials.gov?subject=Multiple sponsors with a brief description of the registry and a list of the sponsors included in the registry. Clinicaltrials.gov will work with sponsors to minimize multiple registrations of the same data. 

 

When we transferred studies from our registry to ClinicalTrials.gov,ClinicalTrials.gov lists the transfer date as the date of registry. Can the date be changed to reflect the original date the study was registered in our registry so that we meet the deadlines specified by ICMJE for publication purposes?
  1. NO The registration date is defined as the date the study was registered in ClinicalTrials.gov. We can not change this date to reflect registration in some other registry. It is suggested that your processes be streamlined to minimize the delay between registration in your registry and the transfer to ClinicalTrials.gov.If you have studies that have already been registered, you should have a dated receipt from the original registry that can be provided to the journal editors upon request. You should also share that registry proof with other trial registrants who wish to publish.

 

I have other questions, where should I direct them?
Email additional questions to: Register@clinicaltrials.gov You may also contact Gail Paulsen, IRB Administrator at 559-3853 or by email at gpaulsen@unmc.edu