Office of Clinical Research

ClinicalTrials.gov is a public registry and results database of both privately and publicly supported clinical studies maintained by the National Library of Medicine (NLM) at the National Institutes of Health (NIH).

The Department of Health and Human Services’ (HHS), Food and Drug Administration (FDA) and National Institutes of Health (NIH), and the International Committee of Medical Journal Editors (ICMJE) all require the public registration of clinical trials. In particular, ICMJE, as a condition of publication, requires the public registration of “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 HHS Final Rule (FDAAA 801), effective January 18, 2017, requires the public registration of clinical trials involving FDA-regulated products (excluding phase 1 trials or small feasibility device studies) to ClinicalTrials.gov, including the publication of results, to ClinicalTrials.gov.

• FDAAA 801 establishes penalties for Responsible Parties who fail to comply with registration or results submission requirements. Penalties include civil monetary penalties and, for federally funded studies, the withholding of grant funds.

NIH Policy, also effective January 2017, requires the public registration of all fully or partially NIH funded clinical trials, regardless of phase to ClinicalTrials.gov. 

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There are differing and overlapping requirements stipulated by several organizations and regulatory bodies. If your trial meets any of the following requirements, it must be registered on ClinicalTrials.gov by the responsible party.

ICJME Requiements

• The ICMJE requires registration of clinical trials in a public trials registry at or before the time of first patient enrollment as a condition of consideration for publication.
• The ICMJE defines a “clinical trial” as any research project that prospectively assigns people or a group of people to an intervention, with or without concurrent comparison or control groups, to study the cause-and-effect relationship between a health-related intervention and a health outcome.
• Health-related interventions are those used to modify a biomedical or health-related outcome; examples include drugs, surgical procedures, devices, behavioral treatments, educational programs, dietary interventions, quality improvement interventions, and process-of-care changes.

FDA Requiements

• The FDA Final Rule requires the public registration of all Applicable Clinical Trials (ACT) involving FDA-regulated products (excluding phase 1 trials or small feasibility device studies).
• 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
• ClinicalTrials.gov provides a checklist for determining if a clinical trial or study is an ACT under the final rule.  The checklist can be found at: https://prsinfo.clinicaltrials.gov/ACT_Checklist.pdf

NIH Requirements

• NIH Policy requires the public registration of all clinical trials funded wholly or partially by NIH.
• For purposes of this policy, the NIH defines "clinical trial" 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."
• The NIH definition of “clinical trial” definition encompasses phase 1 trials of FDA-regulated drug and biological products, small feasibility studies of FDA-regulated device products, and studies of any intervention not regulated by the FDA, e.g., behavioral interventions.

The PSOM Office of Clinical Research recommends all studies that meet the NIH definition of a “clinical trial” be registered with ClinicalTrials.gov.

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There are several differing registration requirements.

ICJME Requirements

• Registration is required at or before the time of first patient enrollment as a condition of consideration for publication.

FDA Requirements

• A research protocol must be registered no later than 21 days after enrollment of the first participant.

NIH Requirements

• A research protocol must be registered no later than 21 days after enrollment of the first participant.

The PSOM Office of Clinical Research recommends that you create your ClinicalTrials.gov record and submit it for PRS review just after securing initial IRB approval of your research protocol, but prior to enrollment of the first subject.

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First, an account will need to be created so you can log in to create your record with in the PRS system.  To do this, email the Office of Clinical Research at  ocrctgov@pobox.upenn.edu.  The email should contain:

• full name
• UPenn email address
• phone number

The Office of Clinical Research (OCR) will typically create your account within 1 business day. If there are others who will need to access the record, please provide their full name, UPenn email and phone number so an account can be created for them, as well.

• Your account information and temporary password will be sent to the email address you provided.
• When you have received your account information and temporary password, navigate to http://register.clinicaltrials.gov and input your username and password. For “Organization,” indicate UPenn. Next, click “New Record” in the top left of the Home page in the Quick Link section. Then follow the prompts to enter your protocol information. You will automatically become the Record Owner for this protocol if you are the initial person to register the study.
• Please be aware that, when prompted to provide a “Unique Protocol ID” by the PRS system, the IRB protocol number must be used. 

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Email OCR at ocrctgov@pobox.upenn.edu and a UPenn PRS administrator will notify you of your username, reset your password, or create a new account.

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The NCT Number, also called the ClinicalTrials.gov Identifier or National Clinical Trial Identifier, is assigned after the UPenn’s ClinicalTrials.gov Administrator has released your protocol record to PRS for review, all PRS review questions have been resolved, and the record is publicly released by PRS. 

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• PRS has published a detailed guide for how to complete each module.  This guidance can be found at: https://prsinfo.clinicaltrials.gov/prs-users-guide.html.
• The PRS Users Guide provides precise notes and explanations for each question within the protocol modules so that it’s clear what each field is requesting. Pay attention to these notes and details to help expedite authorization of the public release of your record.
• As you complete the section, errors, warnings, 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
  • Note – Messages in blue indicate a point to consider and not necessarily a problem
• Records with unresolved errors, and warnings may not be submitted by Penn for PRS review.
• Please be aware that, when prompted to provide a “Unique Protocol ID” by the PRS system, the IRB protocol number must be used. How do I submit my record for posting to ClinicalTrials.gov?

• Click “Entry Complete” within your PRS record to notify the UPenn ClinicalTrials.gov Administrator that your record is ready for release to PRS for evaluation. UPenn ClinicalTrials.gov Administrator will be automatically notified and will typically approve and release the record within 1 business day.
• There will be a delay only if there are any errors, warnings, alerts, or notes still present in your record. UPenn’s ClinicalTrials.gov Administrator will contact you with a request that you resolve these items so that the process can move forward. 

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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 90 days.

• PRS Review Comments provided at the time of this release will be labeled as either Major Comments or Advisory Comments. While each Major issue identified in the comments must be corrected or addressed, Advisory issues are suggestions to help improve the clarity of the record.

Resources:

• Protocol Review Criteria — Describes review criteria for study records submitted to the registry (June 2018)
• Results Review Criteria: Introduction and Overview — Describes review criteria for each scientific module in the results section of the study record submitted to the results database (June 2018)

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Effective January 18, 1017 the HHS Final Rule (FDAAA 801) requires the public registration of clinical trials involving FDA-regulated products to ClinicalTrials.gov, including the publication of results, to ClinicalTrials.gov. NIH Policy requires the public registration of all clinical trials funded wholly or partially by NIH, to ClinicalTrials.gov, including the publication of results.

Posting results on ClinicalTrial.gov depends on if the trial is determined to be an Applicable Clinical Trial (ACT) under the Final Rule of FDAAA (801). Please see the Applicable Clinical Trial Checklist to determine if your trial is subject to the Final Rule https://prsinfo.clinicaltrials.gov/ACT_Checklist.pdf

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• The Results Section is made up of 6 separate modules:
  • Participant Flow
  • Baseline Characteristics
  • Outcome Measures 
  • Adverse Events
  • Limitations and Caveats
  • Information section. Information on how to complete each module is available here.
• PRS has also published a detailed PRS Users Guide found at https://prsinfo.clinicaltrials.gov/prs-users-guide.html
• ClinicalTrials.gov makes available example study records and study papers to illustrate key concepts for results data entry in PRS. 
  • Parallel Study Design
  • Cross-over Study Design
  • Dose Escalation Study Design
  • Factorial Study Design
  • Multiple Period Study Design

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• If the trial was terminated before data was collected for one or more outcome measures, then set the “Overall Recruitment Status” to “Withdrawn.”
  • No further results information will be required.
     
• If the trial that was terminated after participants were enrolled, then set the “Overall Recruitment Status” to “Terminated” and 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

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Your study needs to be updated at various time points during the life of your protocol. 

• Study Amendments: Study amendments need to be incorporated into your record at least once every twelve months.
  • Applicable to FDA-regulated studies (excluding phase 1 studies and small device feasibility studies) must be updated not less than once every 12 months. If Overall Recruitment Status changes, then the status must be updated not later than 30 calendar days after any change in that status. The Primary Completion Date must be updated not later than 30 calendar days after the clinical trial reaches its actual primary completion date.
• Results:
  • ICMJE encourages, but does not require that results be posted to the PRS system.
  • HHS Requirements: Applicable Clinical Trial results must be updated not less than once every 12 months.
  • Intervention Name(s) must be updated to a non-proprietary name not later than 30 calendar days after a non-proprietary name is established for any intervention included in the Intervention Name(s) data element
  • Primary Completion Date must be updated not later than 30 calendar days after the clinical trial reaches its actual primary completion date. At the time, the date is changed to “actual,” the Enrollment data element specifying the actual number of participants enrolled must also be submitted.
  • Study Completion Date must be updated not later than 30 calendar days after the clinical trial reaches its actual study completion date.
  • Overall Recruitment Status must be updated not later than 30 calendar days after any change in overall recruitment status. If, at any time, Overall Recruitment Status is changed to “suspended,” terminated,” or “withdrawn,” the responsible party must also submit the “Why Study Stopped” data element.
  • Record Verification Date must be updated any time the responsible party reviews the complete set of submitted clinical trial information for accuracy and not less than every 12 months, even if no other updated information is submitted at that time.

PRS recommends that your record be reviewed and verified every 6 months, at minimum. The OCR recommends that the record be checked for accuracy each time an IRB amendment is submitted and approved. Incorporating your update into the amendment process more easily triggers you to update your PRS record, reduces the likelihood of a large accumulation of changes, and reduces the likelihood that you will fail to update within the required 6-month period.

If needed, you can check previous versions of your record by entering the NCT number for a given record at the ct.gov archives site https://clinicaltrials.gov/archive/. The NCT number is the number that PRS assigned to the record upon its public release. It begins with “NCT.” (Eg. NCT12345678) When you’re in the study record, the number is next to the word, “Identifiers.”

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Log into https://register.clinicaltrials.gov, click on “Modify,” then “Edit” to open the study. Make changes as needed. If no changes have occurred in the last 6 months, update the Record Verification Date by clicking the “Edit” button next to the field. Then click “Complete” to notify the UPenn ClinicalTrials.gov Administrator your record’s update is ready for release to PRS. 

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All PRS Review Comments provided will be labeled as either Major Comments or Advisory Comments.While each Major issue identified in the comments must be corrected or addressed, Advisory issues are suggestions to help improve the clarity of the record.

• PRS Quality Assurance (QA) comments must be responded to not later than 15 calendar days for registration information and not later than 25 days for results information.
• If you have questions regarding the comments made by the PRS, contact register@clinicaltrials.gov to reach the PRS Quality Assurance team. If you choose, a telephone conference can be set up with the NIH Results Reporting Team. You should receive a response within 1-2 business days.

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Within the PRS system, the “Responsible Party,” a term defined in U.S. Public Law 110-85, Title VIII, Section 801, is ultimately held accountable for the submission and maintenance of the PRS record. It is a requirement of ClinicalTrials.gov that a responsible party be named in the record. “Responsible party” means one of the following:

• The sponsor of the clinical trial (as defined in 21CFR50.3(e) (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

If you are unsure of whether you are the Responsible Party, please contact ocrctgov@pobox.upenn.edu.

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Please email ocrctgov@pobox.upenn.edu with your request and provide the following:

• ClinicalTrials.gov Identifier – This is the number that PRS assigned to the record upon its public release. It begins with “NCT” (e.g., NCT12345678). When you’re in the study record, the number is next to the word, “Identifiers.”
• Organization name
• Individual Username – This is the username of the person who will be managing that particular record at the new organization as the new ‘Responsible Party’
• Grant Number – This number is only required if the study is NIH funded. 

The UPenn ClinicalTrial.gov Administrator will then submit your request to PRS. Turnaround time for the transfer of a record is typically within 1-2 business days.

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Contact University of Pennsylvania PSOM ClinicalTrials.gov Administrators by emailing ocrctgov@pobox.upenn.edu.

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