ClinicalTrials.gov | CTSC | UC Davis Health

ClinicalTrials.gov is a registry and results database managed by the National Institutes of Health (NIH) that provides information on publicly and privately supported clinical studies involving human participants. Registration is required by several bodies, including the Department of Health and Human Services (HHS), the Food and Drug Administration (FDA), the NIH, and the International Committee of Medical Journal Editors (ICMJE), all require the public registration of clinical trials and, in some cases, the posting of trial results.

For non-cancer studies, principal investigators (PIs) must register their own studies in the Protocol Registration & Results System (PRS) at http://register.clinicaltrials.gov.
The UC Davis institutional account name is UCaliforniaDavis.

To obtain a user account or to appoint a designee to maintain the ClinicalTrials.gov record on their behalf, PIs of non-cancer studies must complete the following:

1. Send an email requesting an account to hs-ctgov@ucdavis.edu

• In the subject line type "CT.gov Account Request"
• In the body of the email provide the following information for the intended designee(s):
  • Email address
  • Phone Number
  • IRB number (of trial being registered)
    If the designee needs access to all of the PI's trials in the PRS, please list all applicable IRB numbers. 
    
    Please note, only PIs can appoint their own designee(s) and a designee must have a UC Davis email address to qualify for a user account.

2. The designee(s) will receive an email within 48 hours of the request with login name and temporary password.

3. The designee(s) must log into the PRS system using their login name and temporary password.

4. Navigate to the ‘Accounts’ tab and select “Change Password” to replace the temporary password with something permanent.
For cancer studies, the Program Managers in the Comprehensive Cancer Center (CCC) will register and maintain ClinicalTrials.gov records as designee(s) of the Principal Investigator. Please email Colleen Pineda capineda@ucdavis.edu or Nancy Ogihara nlogihara@ucdavis.edu for assistance.

To complete the registration process, refer to the following guidance documents:

• ClinicalTrials.gov (PRS) Registration User Guide - A step-by-step guidance with screenshots.
• Data Sharing Plan Info Sheet - Guidance for meeting the International Committee of Medical Journal Editors (ICMJE) data sharing requirements
• Requirements for Posting - Institutional requirements for every registration record.
• Remember that:
  • Follow ClinicalTrials.gov Quality Control (QC) Criteria.
  • The registration is not submitted for internal QC review until the user clicks on "Entry Complete" in the system.
  • It is mandatory that the IRBNet number is used as the Primary Protocol ID during registration, without any dashes. For example, the number should be entered as 123456, not 123456-7.

Help sessions via Zoom are available upon request.

UC Davis policy requires registration of all clinical trials (all phases and intervention types) before enrollment of the first subject to ensure compliance.

Failure to register and submit results within the required time frame may result in civil monetary penalties and loss of funding from federal agencies.

Key trials that must be registered include:

• Applicable Clinical Trials (ACT) per Food and Drug Administration Amendments Act (FDAAA); with a study start date on or after January 18, 2017
• Clinical Trials funded either in whole or in part by the National Institutes of Health (NIH) where the NIH application/proposal or IRB approval was received on or after January 18, 2017
• Trials that plan to publish study results in a journal that follows the International Committee of Medical Journal Editors (ICMJE) registration requirements and began on or after July 1, 2005; or
• Qualified clinical trials that bill Center for Medicare and Medicaid Services (CMS) for routine items and services that qualify for coverage under the Medicare National Coverage Determination (NCD) 310.1. CMS requires billable claims for research-related items and services provided during the clinical trial to include the provider’s National Clinical Trial (NCT) number. The NCT number is obtained by registering on ClinicalTrials.gov.
• PCORI-funded patient registries and clinical studies must be registered on ClinicalTrials.gov. For more information on Patient-Centered Outcomes Research Institute (PCORI) requirements for registration, click here.
• Your funding agency may have its own requirements; be sure to check the terms of your award letter.

• Check the ACT Checklist
• Registration is required under any of the following conditions:
  • The Food and Drug Administration (FDA) requires that all “applicable clinical trials” (ACT) be registered to CT.gov within 21 days of the first participant’s enrollment. The FDAAA Decision Tree helps determine whether a study is an ACT.
• The International Committee of Medical Journal Editors’ (ICMJE) Uniform Requirements for Manuscripts Submitted to Biomedical Journals is contingent on CT.gov registration prior to the first participant’s enrollment.
• NIH-funded clinical trials require registration. NIH has a decision tree for determining if the study is a clinical trial.
• Per the Centers of Medicare and Medicaid Services (CMS),qualifying UCD clinical trials of therapeutic intent that evaluate an item or service that falls within the Medicare benefit category require registration to CT.gov

According to UC Davis policy and International Committee of Medical Journal Editors (ICMJE) journal requirements, studies must be fully registered (i.e., a National Clinical Trial (NCT ) number obtained) before enrolling the first participant. You can start the registration process once you have completed the IRB application. While IRB approval is not necessary to begin registration on ClinicalTrials.gov, it is recommended to wait for IRB approval of your protocol to ensure consistency.

Internal quality control (QC) review of a ClinicalTrials.gov registration record is a collaborative process between our office and the study team that can take approximately two weeks, depending in part on how quickly the study team resolves internally identified QC issues and whether a help session is needed.

Once the record is released to ClinicalTrials.gov, the ClinicalTrials.gov QC review typically takes 2 to 5 days. If the QC review identifies issues requiring further edits by the study team, the record will undergo another internal QC review before being re-reviewed by ClinicalTrials.gov according to the same timelines.

The Responsible Party (typically the Principal Investigator) is accountable for ensuring compliance with regulations and updating the trial record. Provided certain stipulations have been met, UC Davis/UC Davis Health designates the main Principal Investigator (PI) as the Responsible Party for the following clinical trials:

• Trials in which the PI holds the Investigational New Drug (IND)/Investigational Device Exemption (IDE) (the PI is also considered the sponsor-investigator).
• Trials initiated by the Principal Investigator.
• NIH-sponsored trials for which UC Davis/UC Davis Health is the grantee institution.
• Trials, initiated by private industry or other outside entities, for which the Principal Investigator accepts the role of the Responsible Party in an explicit agreement.

As outlined in the Declaration of Helsinki, researchers, authors, and sponsors have an ethical obligation to publish and disseminate research results, whether positive, negative, or inconclusive.

As outlined by the International Committee of Medical Journal Editors (ICMJE) and ClinicalTrials.gov, registering your trial and posting results serves to:

• Inform the public about ongoing and upcoming trials.
• Prevent selective reporting of research outcomes.
• Avoid duplication of research efforts.
• Provide ethics review boards with relevant data.
• Contextualize study results for editors and reviewers.
• Support the ethical obligation to disseminate research findings, as outlined in the Declaration of Helsinki.

Yes, ClinicalTrials.gov study records must be updated at least every 12 months. Additional changes to study status or protocol amendments are to be updated within 30 days. Any errors, deficiencies, and/or inconsistencies identified by ClinicalTrials.gov or the Responsible Party must be corrected within 15 days for registration data and 25 days for reportable results.

The following resources are available to you:

• Information on how to complete each of the four results modules
• Descriptions of precisely what each data field requires
• Examples for how to complete data entry for different study types
• ClinicalTrials.gov's Results QC Criteria
• Help sessions are available upon request

Contact our office as soon as possible so we can collaborate with you to either update and finalize your public records or, if applicable, transfer them to your new institution.

The revised Common Rule requires awardees of clinical trials funded by a Common Rule agency (NIH, AHRQ, etc.) that were IRB-approved on or after January 21, 2019, to publicly post one (blank) informed consent form, used to consent participants, to ClinicalTrials.gov.

Only forms posted (1) after a study is closed to recruitment, and (2) where 60 or fewer days have passed since the last study visit by any enrolled subject satisfy the regulatory requirement.

ClinicalTrials.gov is undergoing a multi-year Beta Modernization effort to improve the user experience, functionality, and accessibility of the platform for all stakeholders, including researchers, study participants, and the public. The goal is to make it easier to find, submit, and manage information on clinical trials.

Key features of the modernization include:

• Updated User Interface: A cleaner, more intuitive layout for trial search, results submission, and data updates.
• Enhanced Search Functionality: Improved filters, search suggestions, and more refined results to make it easier to locate trials relevant to specific interests or conditions.
• Mobile-Friendly Design: Responsive design changes ensure that users can efficiently access and manage data on ClinicalTrials.gov from any device, including smartphones and tablets.
• Streamlined Results Submission: Tools to help researchers submit trial results more easily, with added guidance and checks to reduce errors and inconsistencies in data entry.
• Integration of Feedback: The modernization incorporates user feedback, with regular updates and new features being rolled out based on the needs of the research community.

For more details on the modernization process and upcoming features, visit ClinicalTrials.gov Modernization.