ClinicalTrials.gov

A new NIH policy and a FDA Notice of Proposed Rule Making were released on November 21, 2014. Changes to the current policies and regulations governing ClinicalTrials.gov are anticipated in 2016.

ClinicalTrials.gov Protocol Registration System (PRS) Link:  http://register.clinicaltrials.gov.

FAQs: Below are some general, frequently asked questions regarding ClinicalTrials.gov. If you don't find the answer to your question please contact us at either OCR@Emory.edu or 404-778-4960.

What is ClinicalTrials.gov?

ClinicalTrials.gov is a web-based resource that provides patients, their family members, health care professionals, researchers, and the public with easy access to information on federally and privately supported clinical studies on a wide range of diseases and conditions in the United States and across the world. The ClinicalTrials.gov website is maintained by the National Library of Medicine (NLM) at the National Institutes of Health (NIH). Clinical studies are registered on ClinicalTrials.gov via a web-based data entry system called the Protocol Registration System (PRS). Information on ClinicalTrials.gov is provided and updated by the Sponsor or Principal Investigator of the clinical trial. Studies should be submitted to the website (i.e., registered) prior to enrollment of the first subject, and the information on the site is updated throughout the duration of the study. ClinicalTrials.gov is often referred to as a publically available "registry" and "results database”.

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Who is Responsible for ClinicalTrials.gov Registration?

The Responsible Party for a clinical trial must register the trial and submit results information. The Responsible Party is defined as:

  • The Sponsor of the clinical trial (e.g., Industry Sponsor, Federal Sponsor, or Investigator-initiated);

                                                                      or

  • The Principal investigator (PI) of a clinical trial if an Investigator-initiated study or if designated by a sponsor, grantee, contractor, or awardee, so long as the PI 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 FDAAA's requirements for the submission of clinical trial information.


Note:
  For Emory Investigator-initiated studies, OCR is willing to assist with determining if ClinicalTrials.gov registration is necessary. Emory OCR will also assist with entering and updating the information in the ClinicalTrials.gov on behalf of the study team. Please contact OCR at either OCR@Emory.edu or 404-778-4960 for questions, etc.

The “Responsible Party”, or Sponsor, for a clinical research trial must register and “Approve/Release” the trial on ClinicalTrials.gov. This includes clinical trials in which an Emory Investigator is the Primary (i.e., Lead) Investigator for the overall study (e.g., investigator-initiated trials that are multi-center) where Emory is in control of all data need to be registered in ClinicalTrials.gov by the Emory Investigator.  ClinicalTrials.gov registration is not completed by site Principal Investigators for clinical trials that are managed by other sponsors or institutions, such as industry-sponsored studies. If a study is being conducted at multiple institutions, the Lead or Primary Investigator should register the trial.

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Who Registers a Clinical Trial conducted by an Emory University Investigator?

It is the PI's responsibility to ensure that Emory-Sponsored clinical trial registration in ClinicalTrials.gov meets the requirements of applicable laws and regulations. Acceptance by ClinicalTrials.gov and assignment of an NCT number to a registration record does not ensure compliance with applicable laws – the study record must be maintained and accurate throughout the course of the research study. However, Emory OCR is willing to assist the study team with registration of the study, updating the study record for amendment changes, maintaining updates, and results reporting, as applicable.

Additionally, while most Industry-Sponsored studies are registered by the Industry-Sponsor, it is the Emory Site PI's responsibility to ensure that trials conducted are registered with complete information in ClinicalTrials.gov. For background reading, see NEJM editorial Salvation by Registration, January 2007.

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What is the responsibility of the Principal Investigator at Emory University if the Clinical Trial is Industry-Sponsored?

The Principal Investigator at Emory (i.e., the Site PI) should discuss the status of ClinicalTrials.gov registration with the Industry or Federal Sponsor to ensure that the study is in agreement with the study contract. Additionally, the Principal Investigator should request the NCT number, if applicable, in order to provide this information to Emory’s Office for Clinical Research.  CMS regulations require the NCT number to be submitted with all Medicare claims for patients receiving reimbursable services as part of a clinical trial or the claim will be rejected. While Phase 1 studies are exempt from current FDA regulations requiring registration, the NCT number may be needed for billing and reimbursement purposes if the study has Emory billable items/services.

 

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What is the definition of a Clinical Trial for the purpose of registration?

If a research study meets any one of the following definitions, the trial must be registered on ClinicalTrials.gov:

  • The Food and Drug Administration (FDA) requires registration for “Applicable Clinical Trials”  (ACTs) defined as follows:
    • For any trials of drugs and biologics: Controlled clinical investigations, other than Phase I investigations, of a product subject to FDA regulation.
    • For trials of biomedical devices: 1) Controlled trials with health outcomes of devices subject to FDA regulation, other than small feasibility studies, and 2) pediatric post-market surveillance required by FDA.

"Applicable clinical trials" generally include interventional studies (with one or more arms) of FDA-regulated drugs, biological products, or devices that meet one of the following conditions:

  • The trial has one or more sites in the United States.
  • The trial is conducted under an FDA investigational new drug application or investigational device exemption.
  • The trial involves a drug, biologic, or device that is manufactured in the United States or its territories and is exported for research.

For more information on the definition of an "Applicable Clinical Trial," see Elaboration of Definitions of Responsible Party and Applicable Clinical Trial (PDF).

Note:  If you are the Investigator of a Phase I Clinical Trial that has Emory HealthCare billable items and services, the study must be registered in ClinicalTrials.gov in order to obtain a NCT number (ClinicalTrials.gov Identifier). The NCT number is required for the processing of Medicare Reimbursement Claims.

  • International Committee of Medical Journal Editors (ICMJE) defines a clinical trial as: 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.
  • The National Institutes of Health (NIH) recommends registration of all clinical trials that meet the following definition: A research study1 in which one or more human subjects2 are prospectively assigned3 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 outcomes5.

1See Common Rule definition of “research” at 45 CFR 46.102(d)

2See Common Rule definition of “human subject” at 45 CFR 46.102(f)

3The term “prospectively assigned” refers to a pre-defined process (e.g., randomization) specified in an approved protocol that stipulates the assignment of research subjects (individually or in clusters) to one or more arms (e.g., intervention, placebo, or other control) of a clinical trial.

4An “intervention” is defined as a manipulation of the subject of subject’s environment for the purpose of modifying one or more health-related biomedical or behavioral processes and/or endpoints.  Examples include:  drugs/small molecules/compounds; biologics; devices; procedures; (e.g., surgical techniques); delivery systems (e.g., telemedicine, face-to-face interviews); strategies to change health-related behavior (e.g., diet, cognitive therapy, exercise, development of new habits); treatment strategies; prevention strategies; and, diagnostic strategies.

5A “health-related biomedical or behavioral outcome” is defined as the pre-specified goal(s) or condition(s) that reflect the effect of one or more interventions on human subjects’ biomedical or behavioral status or quality of life.”  Examples include:  positive or negative changes to psychological or neurodevelopmental parameters (e.g., mood management intervention for smokers; reading comprehension and/or information retention); positive or negative changes to disease processes; positive or negative changes to health-related behaviors’ and, positive or negative changes to quality of live.)

Revised Version Issued October 23, 2014

If you are uncertain whether or not your study meets the definition of a clinical trial, you should err on the side of registration. However, please note that if you register a research study with ClinicalTrials.gov, you will be responsible for completing the entry and updating the information throughout the course of the trial. Emory’s OCR will facilitate and assist with the process.

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When will I get my NCT number (ClinicalTrials.gov Identifier)?

A ClinicalTrials.gov staff member will review the study record after it has been “Approved” and “Released” (a 2-step process required for submission of the) by the Responsible Party (or Sponsor), and before it is published on ClinicalTrials.gov. This review will focus on apparent validity (when possible), meaningful entries, logic and internal consistency, and formatting. Please note that the review process may take up to a few days. Ensuring that the record is consistent with the ClinicalTrials.gov protocol review criteria (PDF) before releasing it will expedite publication on the site.

After you release a record and it is accepted by review staff for publication, the record, including its NCT Number (ClinicalTrials.gov Identifier), will be available on ClinicalTrials.gov within 2–5 business days. An email notification with the NCT Number is sent by ClinicalTrials.gov to the “Responsible Party” and “Owner” which includes this information. The record, including its NCT Number, will typically be available on ClinicalTrials.gov within 2–5 business days after it is released.

Note:  After initial review by ClinicalTrials.gov staff, some studies may require a response to “QA Review Comments” prior to the NCT number being assigned and the study being posted to the public website. The study team must address the comments made by ClinicalTrials.gov to move the process forward.

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When is the deadline for initial registration of a Clinical Trial on ClinicalTrials.gov?

The PI or Sponsor for an Applicable Clinical Trial must submit required clinical trial information prior to enrollment of the first participant to meet both ICMJE and FDA requirements.

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What are the penalties for failure to register a Clinical Trial?

FDA:

Civil monetary penalties are allowed under FDA regulations. The failure to submit clinical trial information, including the submission of any false or misleading information or a failure to correct a violation within a 30-day period following notification, will result in civil monetary penalties for Responsible Parties that can range up to $10,000 for each day. For more information: http://www.gpo.gov/fdsys/pkg/PLAW-110publ85/pdf/PLAW-110publ85.pdf#page=98

Additionally, if an applicable clinical trial is federally-funded, penalties may include withholding or recovery of grant funds. For more information: http://www.gpo.gov/fdsys/pkg/PLAW-110publ85/pdf/PLAW-110publ85.pdf#page=95.

ICMJE

Failure to register may result in the inability to publish the results of the trial in an ICMJE-associated journal. Those who are uncertain whether their trial meets the expanded ICMJE definition should err on the side of registration if they wish to seek publication in an ICMJE journal.

A list of journals currently following ICMJE guidelines can be found at http://www.icmje.org/journals-following-the-icmje-recommendations/.

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Who is the Emory PRS Administrator for ClinicalTrials.gov? What is their role?

The PRS Administrator for Emory University is the Office for Clinical Research (OCR).  Emory’s OCR is willing to assist investigators with the following in ClinicalTrials.gov:

  • Establishing user account and temporary password
  • Assist with registration of studies
  • Resetting a password when the original is lost or forgotten
  • Updating study records for protocol amendment changes
  • Assist with required results reporting
  • Changing ownership of a study
  • Assist with resolving “problems” in ClinicalTrials.gov and ensuring maintenance of information reflective of current study status

To request assistance with any of the above items, contact OCR at OCR@Emory.edu.

Note: OCR is not responsible for reviewing the content of information posted on ClinicalTrials.gov, ensuring accuracy of the study information on ClinicalTrials.gov, or submitting an application. This is the responsibility of the PI as the “Responsible Party” for the ClinicalTrials.gov study record.

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What are the additional requirements for ClinicalTrials.gov registration?

  • Informed Consent – Regulations require a statement be included in the informed consent for Applicable Clinical Trials regarding the availability of clinical trial information on ClinicalTrials.gov. The statement is:  "A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This website will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this website at any time." http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=50.25.  

Emory University’s Institutional Review Board (IRB) has a sample Informed Consent template that provides the required language about ClinicalTrials.gov.  Please visit their web page for additional information. http://www.irb.emory.edu/forms/index.html

  • Medicare payment– The Centers for Medicare & Medicaid Services (CMS) now require the NCT number (ClinicalTrials.gov Identifier) on Medicare claims associated with clinical trial participation. Clinical trial related claims submitted to Medicare for dates of services on or after January 1, 2014, will be rejected and returned to the provider if the NCT number is not present. http://researchadmin.iu.edu/News/news-billing_req.html.

Emory University, Office for Clinical Research (OCR) requires research coordinators to provide the NCT Number to our office, upon request, in order to ensure research billing compliance for routine care (standard of care) items and services related to clinical trial participation.

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What are the requirements for updating a registered Clinical Trial?

Records should be updated within 30 days of a change to Recruitment StatusOverall Recruitment Status, and/or Completion Date. Other changes to the protocol or updates to the record must be made at least every 12 months.

It is recommended that the Record Verification Date be updated at least every 6 months for studies that are not yet completed, even if there were no changes to the record.

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What is the deadline for posting study Results?

In general, results of an Applicable Clinical Trial of a drug, biologic, or device that is approved, licensed, or cleared by the FDA must be submitted by the Responsible Party no later than 12 months after the Completion Date, defined in the law as date of final data collection for the prespecified "primary outcome measure". See the statutory definition of Completion Date (PDF).

Delayed Submission of Results

1.  Certification

A Responsible Party may delay submission of results, until the deadline described below, by submitting a certification (see note) that an Applicable Clinical Trial meets either of the following conditions:

    • The trial reached its Completion Date before the drug, biologic, or device is initially approved, licensed, or cleared by the FDA for any use (referred to on ClinicalTrials.gov as "certify initial approval")
      • Results Deadline: Not later than 30 days after the drug or device is approved, licensed or cleared by the FDA
    • The trial studies a new use of an FDA-approved drug, biologic, or device (that is, a use not included in the labeling) for which the manufacturer of a drug, biologic, or device is the sponsor of the trial and has filed or will file within 1 year an application to FDA for approval or clearance of that use (referred to on ClinicalTrials.gov as "certify new use")
      • Results Deadline:

(1) the earlier of the date that is 30 days after the date:

    • New use of the drug or device is approved, licensed, or cleared by FDA;
    • FDA issues a letter for the new use of the drug or device, such as a complete response letter;
    • The application or premarket notification for the new use is withdrawn without resubmission for no less than 210 days; or

 (2) two years after the date a certification is submitted, if none of the events listed above has occurred.


Note:
If a Responsible Party, who is both the sponsor and manufacturer, submits a new use certification this certification must be made with respect to each Applicable Clinical Trial that is required to be submitted in an application or report for licensure, approval, or clearance of the use studied in the clinical trial.

2.  Extension Request

The Director of the National Institutes of Health (NIH) may extend the deadline for submission of results information for an Applicable Clinical Trial if the Responsible Party submits a written request that demonstrates good cause for the extension and provides an estimate of the date on which the results information will be submitted. Pending publication is not considered good cause for an extension.

Submitting a Certification or Request for Extension for Delayed Submission of Results

A certification or request for extension is submitted via the Protocol Registration System (PRS). A study must have a ClinicalTrials.gov Identifier (NCT Number) prior to submission of a certification or request for extension. Submission of this certification will facilitate automated identification of trials that are not yet required to submit results.

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How can someone volunteer for a registered clinical trial at Emory?

Please visit the webpage "Clinical Trials at Emory." http://clinicaltrials.emory.edu/   

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Who to contact if I have questions?

For more detailed information about ClinicalTrials.Gov, please find instructions for Researchers at the following link:  http://clinicaltrials.gov/ct2/help/for-researcher.

  • If you have specific questions about your study/record entry, you can send an email directly ClinicalTrials.gov at register@clinicaltrials.gov.
  • If you need additional help with results entry or understanding QA comments, a teleconference can be requested by contacting ClinicalTrials.gov at register@clinicaltrials.gov.
  • Additionally, Emory OCR is able to answer questions regarding ClinicalTrials.gov registration and study records. Please contact OCR at OCR@emory.edu.

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