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ClinicalTrials.gov

Learn about the ClinicalTrials.gov Registration and Reporting Requirements.

ClinicalTrials.gov (CT.gov) is a public registry aimed at increased transparency and improved public awareness of research. ClinicalTrials.gov captures significant summary protocol information before and during the clinical trial as well as summary results and adverse event information of a completed trial.

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Principal Investigator Responsibilities

For all UC San Diego (UCSD) employees registering a new clinical trial on ClinicalTrials.gov, they must create a user account under the UCSD institutional Protocol Registration and Results System (PRS) account, “UCSDMED.” There are a number of aspects to ClinicalTrials.gov. First, the clinical trial must be registered and updated on ClinicalTrials.gov, then after the clinical trial completion, the results of the trial must be published. See the Factsheets listed below:

  1. Registration: ClinicalTrials.gov User's Guide and Registration (PDF)
  2. Updating: Annual Report and Updating the Study Record (PDF)
  3. Results: Publishing Results and Adverse Events Factsheet (PDF)

UCSD Investigators are responsible for determining whether or not they are obligated to register a clinical trial and for any subsequent required updates, including results reporting. For more information about registration requirements, see “Qualifying Clinical Trials" below.

Designating a Responsible Party

Each clinical trial registered on ClinicalTrials.gov must have a designated Responsible Party (RP). The RP is legally responsible for registering their study record on ClinicalTrials.gov, ensuring accuracy and that the content is up-to-date. There can be only one RP for each clinical trial registered.

If a clinical trial is Industry Initiated/Sponsored, the Industry Sponsor must serve as the RP. Some institutions allow for the Industry Sponsor to transfer the RP duties to the Principal Investigator, however, this is not permitted at UCSD.

UCSD, as an entity, cannot be the RP. Clinical trials must list the Principal investigator or the Industry Sponsor as the RP. Use the Factsheet below to help determine the RP.

Factsheet: Determining the Responsible Party decision tree

Registering Qualifying Clinical Trials

There are a number of regulatory bodies and other entities that require registration and results publication on ClinicalTrials.gov. One or more of these polices may apply. Clinical trials that do not meet the Food and Drug Administration Amendments Act (FDAAA) or National Institute of Health (NIH) requirements may still meet the International Committee of Medical Journal Editors (ICMJE) requirements. See the Factsheet below to help determine if the clinical trial must be registered.

Factsheet: Registration and Results Decision Tree (PDF)

Timeline for Registration and Reporting

UCSD requires submission of all clinical trials that fall under any of the following categories:

FDAAA 801 and Final Rule UCME Policy NIH Policy
Scope Applicable clinical trials (ACT) Interventional clinical trials (broad scope of "intervention") NIH-funded clinical trials
Effective Dates January 18, 2017 July 1, 2005 January 18, 2017
When to register No later than 21 days
of enrollment of the first subject
Prior to first subject enrollment No later than 21 days
of enrollment of the
first subject
Results reporting No later than 12 months after the Primary Completion Date (the last subject last visit) Not required No later than 12 months after the Primary Completion Date (the
last subject last visit)
Phase of
the trial
Excludes Phase 1 (drug) and Feasibility (device) All clinical trials All clinical trials
Funding Source Any Any NIH (either partially
or fully)
Intervention Type All FDA regulated drugs, biologics and devices All (including behavioral, diagnostics, dietary supplements, etc.) All (including behavioral, diagnostics, dietary supplements, etc.)
Potential Enforcement
  • Public notice of
    non-compliance
  • FDA sanctions
  • Civil monetary penalties (up to $10,000/day)
  • Loss of HHS Funding to study and/or institution
Rejection of the publication Loss of NIH funding for the PI AND for UCSD

This chart was adapted from KUMC Research Institute Clinical Research Administration “ClinicalTrials.gov Registration Guide.”

Other funding agencies may require that a clinical trial be registered on ClinicalTrials.gov.  All signatories to the May 18, 2017, WHO, International Clinical Trials Registry Platform (ICTRP) require registration and results reporting from the grantees.  One signatory, for example, is the Bill and Melinda Gates Foundation.  For all external funding and sponsorship, the Principal Investigator is required to review all award letters to ascertain if registration on ClinicalTrials.gov is required.

When are Updates Required?

Throughout the course of a clinical trial, the ClinicalTrials.gov record will need to be updated periodically. Some updates are required within 30 days of changes made to the study and others are required annually.

Factsheet: Annual Reporting and Updating the Study Record (PDF)

Publishing Results

Submission of results information is required no later than 1 year after the primary completion date of the clinical trial, which is defined as the date of final data collection for the primary outcome measure.

Factsheet: Clinicaltrials.gov Instructions for Publishing Results (PDF)

For clinical trials with primary completion dates on or after January 18, 2017, the protocol and statistical analysis plan (SAP) must be uploaded to ClinicalTrials.gov under the “Documents Section.” All documents uploaded to ClincalTrials.gov will be posted publically after it undergoes Protocol Registration and Results System (PRS) review.

Factsheet: Clinicaltrials.gov Instructions for Uploading Study Documents and Redaction Guide (PDF)

Researchers can contact the ClinicalTrials.gov team for assistance. Their support can be particularly helpful when it comes to complex study designs or issues with submitting summary results information into the Protocol Registration and Results System (PRS). In most cases, the ClinicalTrials.gov team provides guidance by email, but in some cases they may also offer to set up a teleconference at a mutually convenient time to discuss study specifics and provide tailored guidance as to how to enter results into PRS. Email ClinicalTrials.gov at register@clinicaltrials.gov.

Clinical Trials Dissemination Plan Requirements

The NIH requires there be a dissemination plan as part of the grant process. The plan must include the following:

  1. That the applicant will ensure that clinical trials under the award are registered and results information is submitted to ClinicalTrials.gov as outlined in the policy and according to the specific timelines stated in the policy;
  2. The informed consent documents for the clinical trial(s) will include a specific statement relating to posting of clinical trial information at ClinicalTrials.gov; and
  3. That the recipient institution has an internal policy in place to ensure that clinical trials registration and results reporting occur in compliance with policy requirements.

The following Factsheet may be provided to the agency or sponsor to address the institutional plan for compliance with the policy requirements.

Factsheet: UC San Diego ClinicalTrials.gov Requirements (PDF)

Frequently Asked Questions (FAQs)

Resources

  1. ClinicalTrials.gov Resources
    1. Applicable Clinical Trial (ACT) determination
      1. Detailed ACT definition
      2. ACT Checklist
      3. ACT FAQs
  1. NIH Resources
    1. Resources for determining if a study is a clinical trial:
      1. NIH Clinical Trial Definition
      2. Case Studies
      3. FAQs
    2. NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information
    3. Requirements for Registering & Reporting NIH-Funded Clinical Trials on ClinicalTrials.gov
  2. Other Resources
    1. ICMJE
      1. Clinical trial recommendations and FAQs
      2. Press release on data sharing statements
    2. World Health Organization- Public Disclosure of Clinical Trial Results
    3. Patient Centered Outcomes Research Institute (PCORI)
      1. PCORI Process for Peer Review of Primary Research and Public Release of Research Findings
    4. Center for Medicare and Medicaid Services (CMS)
      1. See ClinicalTrials.gov help on CMS billing requirements

References

  • Clinical Trials Registration and Results Information Submission - 42 CFR 11
  • Section 801 of the Food and Drug Administration Amendments Act - FDAAA 801
  • NIH dissemination policy - NOT-OD-16-149
  • International Committee of Medical Journal Editors - ICMJE

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