ClinicalTrials.gov Registration

Clinicaltrials.gov Registration

Background

ClinicalTrials.gov is a registry and results database with over 225,000 studies. It was mandated by the Food and Drug Administration Modernization Act of 1997 (FDAMA) and expanded under the Food and Drug Administration Amendments Act of 2007 (FDAAA). In 2016, FDAAA 801 described further registration and results requirements. The Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11.4) expands and clarifies FDAAA 801 and went into effect January 18, 2017.

All “Applicable Clinical Trials” (ACT) are required to be registered within 21 days of enrolling the first participant (FDAAA/Final Rule). Results must be entered on ClinicalTrials.gov within 12 months of the Primary Completion Date.

ClinicalTrials.gov Reporting

 FDAAA & Final RuleNIH-fundedICMJE
Why Register?Federal Law per FDAAA 801 and the Final RuleExpected for all NIH-funded trials even if not subject to FDAAA 801Required by most medical journals
Applicable Clinical Trial? (ACT)ACT ChecklistNIH Clinical Trial DefinitionICMJE Clinical Trial Defintion (Updated Dec. 2018)
Funding SourceAnyNIHAny
EnforcementCriminal proceedings and civil/monetary penalties
Loss of HHS funding
Witholding/loss of NIH fundingRefusal to publish

How do I register?

  1. Send an e-mail to mcwcto@mcw.edu  with your full name, phone number and e-mail address. Put “Request CT.GOV Account” in the subject line.
  2. You will receive an e-mail from the Protocol Registration System (PRS) with your login name and temporary password.
  3. Go to: https://register.clinicaltrials.gov/
  4. Enter your user name and password
  5. In the “Organization” field, type “MCWisconsin”
  6. Change your password under “User Account” on the main menu

How Do I Request a Consultation?

Complete the “Request a Consultation” form at the bottom of this page. Click CTSI Clinical Trials Office and select ClinicalTrials.gov Registration/Consultation from the list of CTO services. Add any specific information in the (Optional) Please provide additional details or specifics for your project section type.

Roles and Responsibilities

Principle Investigator's Roles and Responsibilities

  • Enter the study registration information and ensure that MCW-Sponsored clinical trial registration in ClinicalTrials.gov meets the requirements of applicable laws and regulations. Assignment of a NCT number does not ensure compliance.
  • The study record must be maintained for accuracy and updated throughout the life-cycle of the research study by the Principal party.
  • Study results must be entered, with few exceptions, no later than 12 months after the Primary Completion Date

Medical College of Wisconsin Roles and Responsibilities

  • Provide MCW user accounts and temporary passwords through PRS
  • Reset passwords
  • Notify the study team of Records which require modification due to errors, late results, not being updated etc.
  • Change record ownership
  • Facilitate transfer of study records from previous institutions
  • MCW is NOT responsible for submitting an application or ensuring the accuracy of the content posted on ClinicalTrials.gov

Working with PRS Records

Creating a ClinicalTrials.gov Record

Visit ClinicalTrials.gov How to Register Your Study for a step-by-step explanation of the registration process.

Data Elements Definitions provides a detailed explanation of the data fields within ClinicalTrials.gov. It is highly recommended you use the unique IRB number as the Unique Protocol ID in the PRS data element.

When registering a study, it will have to be decided who is the Responsible Party and the Record Owner. They may be one in the same. By definition:

Responsible Party:  An entity or individual who is responsible for registering a clinical investigation and submitting clinical trial information
– Can be the Sponsor for the trial
– Can be the PI if they conduct the trial, control the data and have the rights to publish

Record Owner:  The primary contact for the record. Anyone can be the owner of a study. Owners are often Study Coordinators or other study team members and assist the Responsible Party (RP) with data entry. They can be assigned to create the study record, grant other users access and receive e-mail communications along with the RP.

Updating a ClinicalTrials.gov Record

The Responsible Party must update and correct clinical trial information on ClinicalTrials.gov:

  • Corrections are required if potential issues are identified as part of the ClinicalTrials.gov quality control review or if the responsible party becomes aware of errors
  • It is recommended that the Record Verification Date be updated at least every 6 months for studies not yet completed, even if there were no changes to the record
  • Generally required to update information at least once every 12 months such as anticipated study end date, protocol amendments, etc.
  • Some data elements must be updated more rapidly
    • FDAAA – Update within 30 days of any changes to Overall Recruitment Status or Primary Completion Date
Adding the Results Section to ClinicalTrials.gov
  • Standard results submission deadline
    • Applies to applicable clinical trials required to have results information submitted (under 42 CFR 11.42)
    • Results information must be submitted no later than 1 year after the Primary Completion Date
  • Exceptions: Delayed submission
    • Seeking approval, licensure, or clearance of a new use
    • Seeking initial approval, licensure, or clearance
    • Extensions for good cause
Posting of the Informed Consent in the PRS Record (Effective January 21, 2019)

The final revisions to the Common Rule related to posting the Informed Consent were effective January 21, 2019:

  1. For each clinical trial conducted or supported by a Federal department or agency, one IRB-approved informed consent form used to enroll subjects must be posted by the awardee or the Federal department or agency component conducting the trial on a publicly available Federal Website that will be established as a repository for such informed consent forms.
  2. If the Federal department or agency supporting or conducting the clinical trial determines that certain information should not be made publicly available on a Federal Web site (e.g. confidential commercial information), such Federal department or agency may permit or require redactions to the information posted.
  3. The informed consent form must be posted on the Federal Web site after the clinical trial is closed to recruitment, and no later than 60 days after the last study visit by any subject, as required by the protocol.

In addition:

  • Acceptable Federal Web sites include ClinicalTrials. gov and Regulations.gov
  • The Consent form must have been used to enroll patients
  • There is no requirement to post consent forms prior to January 21, 2019
  • Consent forms may be uploaded in the PRS Document Section

Further Reading and Resources

Clinical Trials Reporting: NIH Policy & HHS Final Rule. NIH Regional Seminar May 2017, Kristina Elliott, MLS (Powerpoint)

Journals following the ICMJE recommendations

NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information

Hudson KL, Lauer MS, Collins FS. Toward a new era of trust and transparency in clinical trials. JAMA; [2016 Oct 4;316(13):1353-1354 [Full Text]

Zarin DA, Tse T, Williams RJ, Carr S. Trial reporting in ClinicalTrials.gov – the final rule. N Engl J Med; 2016 Sept 16. [Full Text]

Zarin DA, Tse T, Ross JS. Trial-results reporting and academic medical centers. N Engl J Med. 2015 Jun 11;372(24):2371-2. [Full Text]

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Updated February 1, 2019