Institutional Review Board

Registration on ClinicalTrials.gov

What is the requirement? What is the timeline for registration?  What is the penalty for not complying? 

Registration of a clinical trial in ClinicalTrials.gov and maintenance of the clinical trial record is required by several regulatory bodies and committees. Additionally, failure to comply can result in penalties. Food and Drug Administration Amendments Act of 2007 801, National Institutes of Health, International Committee of Medical Journal Editors and Centers for Medicare and Medicaid Services are the most commonly referenced requirements. Please note that the clinical trial may be subject to other policy or sponsor requirements.

Regulation/Policy 

Timeline for Registration 

Results Reporting Required 

Penalty for Not Complying 

Food and Drug Administration Amendments Act of 2007 801

21 days post first subject enrollment

Yes

Initial $10,000 and $10,000/day for the duration of the violation (uncorrected violations), withholding of funds, sanctions

NIH

21 days post first subject enrollment

Yes

Withholding cash payments, disallowing cost of activity, suspending or terminating current award, withholding future award.

ICMJE

At or before first subject enrollment

No

Inability to publish in prominent journals

CMS

Prior to submission of claim

No

Claims will not be paid

 

For registration purposes, how is "clinical trial" defined and what are the registration deadlines? 

According to the Food and Drug Administration (FDA): 2007 Definition: The Food and Drug Amendments Act (Title VIII. Sec. 801) requires registration for all “applicable clinical trials,” including Federal, industry-sponsored, and investigator-initiated that are:

  • Trials of drugs and biologics: Controlled, clinical investigations, other than Phase I investigations, of a product subject to FDA regulation, and
  • Trials of devices: Prospective clinical studies of health outcomes comparing an intervention with a device against a control in human subjects (other than small clinical trials to determine the feasibility of a device, or clinical trials to test prototype devices where the primary outcome measure relates to feasibility and not to health outcomes; and pediatric postmarket surveillance studies, as required under the Federal Food, Drug and Cosmetic Act.

According to the National Institutes of Health (NIH): 2016 Definition: The NIH Policy applies to all clinical trials funded in whole or in part by NIH, regardless of study phase, type of intervention, or whether they meet the FDA definition. The NIH Policy applies to clinical trials which are defined as “a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.” 

According to the International Committee of Medical Journal Editors (ICMJE) a clinical trial is: "any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes." Health-related interventions include any intervention used to modify a biomedical or health-related outcome (for example, drugs, surgical procedures, devices, behavioral treatments, dietary interventions, and process-of-care changes). Health outcomes include any biomedical or health-related measures obtained in patients or participants, including pharmacokinetic measures and adverse events.  

 

Who is responsible for registering a trial?  

Normally, the clinical trial will be registered by the sponsor.

  • However, NIH-sponsored trials should be registered by the PI.
  • Industry-sponsored trials (industry-written protocol) should normally be registered by the industry sponsor.

Multi-site trials should be coordinated among the sites and registered by the “lead sponsor” so that ClinicalTrials.gov does not receive multiple registrations for the same trial.
Some trials will need to be registered by the Principal Investigator (PI) at Einstein/MMC.

  • Investigator-initiated trials (for which industry has supplied drug or grant funds) should normally be registered by the PI.
  • Trials for which PIs hold their own INDs or IDEs should normally be registered by the PI. (PIs who hold their own INDs or IDEs are considered to be the trial sponsors.)
  • Trials that the sponsor has declined to register.

The PI is ultimately responsible for determining that registration requirements are met. Although some sponsors will do the actual registration work, it is still the PI’s responsibility to ensure that the registration has been accomplished. Before enrolling subjects, every PI should ask the study’s sponsor, “Is this study fully registered?” If the sponsor responds affirmatively, PIs should personally check ClinicalTrials.gov to ensure that the trial has been registered. For registration instructions Einstein/MMC, see below “How do PIs register their trials? 

Are there any exceptions?  

Yes. Purely observational studies (those in which the assignment of the medical intervention is not at the discretion of the investigator) do not require registration.

How is Einstein/MMC involved?
Einstein and MMC are already registered as an institution at ClinicalTrials.gov, and hundreds of Einstein- and MMC- based trials have already been registered at this site. In addition, ClinicalTrials.gov asks each institution to identify a PRS administrator.

At Einstein/MMC, the administrator is Marina Tuzova.  You may contact her at marina.tuzova@einstein.yu.edu.    

How do PIs register their trials?  

If after reading this information, you determine that you need to register your clinical trial at ClinicalTrials.gov, call your trial's sponsor/program officer. Ask whether the trial has already been registered and/or whether the sponsor intends to register the trial.

  • If the answer is "no" to both questions, then go to https://register.clinicaltrials.gov/ to register your study.  You will need an active user account to access the system.  If you need one created or are unsure if you have one, email the Einstein/MMC Administrator at marina.tuzova@einstein.yu.edu.
  • If the sponsor states that the trial has already been registered, check the information about your trial on ClinicalTrials.gov. (e.g., for multi-site studies, be sure that your site is listed and that the information is accurate.)
  • If the sponsor intends to register the trial, be sure that registration occurs before you enroll your first subject. Once the trial has been registered, check the record for accuracy.

Registration instructions are also available here. An FAQ is available here.

When do PIs need to submit the results of their trials? 

In general, results of an Applicable Clinical Trial of a drug, biologic, or device that is approved, licensed, or cleared by FDA must be submitted by the Responsible Party no later than 12 months after the Completion Date (see Primary Completion Date data element on ClinicalTrials.gov).

You can learn more about how to submit your results here and here.

How can trial records be transferred from one Protocol Registration System (PRS) account to another?  

  • The owner of a protocol record (usually the account administrator or the Responsible Party), or an employee from the owner's organization can request the transfer by emailing the following information to register@clinicaltrials.gov:
  • the National Clinical Trial (NCT) number of the record (or the Unique Protocol ID if no NCT number has been issued yet),
  • the name of the organization (or the PRS organizational account) to receive the trial,
  • the account owner’s name (user name; note: this user name must already exist in the recipient PRS organization account),
  • any NIH grant numbers applicable to this protocol.

The account administrator should review the FAQ “Can a protocol record be transferred between organizations?” which is available once they have logged in to the PRS (click on “FAQ”).

If the trial is currently registered in an NIH Institute or Center PRS organizational account, please contact that IC to make the transfer.  The NIH Institute or Center will use its administrative access to transfer the trial to the new account.  Provide the same information described above.

Who is the “responsible party”? 

As defined in US Public Law 110-85, Title VIII, Section 801, the term "responsible party," with respect to a clinical trial, means:

The sponsor of the clinical trial (as defined in 21 CFR 50.3) or

The principal investigator of such clinical trial if so designated by a sponsor, grantee, contractor, or awardee, so long as the principal investigator is responsible for conducting the trial, has access to and control over the data from the clinical trial, has the right to publish the results of the trial, and has the ability to meet all of the requirements for the submission of clinical trial information.

For all investigator initiated Einstein/MMC studies, the principal investigator should be listed as the responsible party.

What does the “responsible party” have to do? 

The Responsible Party (Principal Investigator) must have a PRS account, must be given access to the record by the record owner or PRS Administrator, and must ‘release’ the record to ClinicalTrials.gov for publication. A PRS account can be obtained by contacting the Einstein/MMC Administrator at marina.tuzova@einstein.yu.edu .  

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