ClinicalTrials.gov

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 “Registering Qualifying Clinical Trials" below.

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

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)

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

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.

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)

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 publicly 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.

The “Revised Common Rule” requires clinical trials conducted or supported by a Common Rule department or agency to post a copy of the approved informed consent form to a publicly available federal website within a specific timeframe. This new regulation applies to all clinical trials initiated on or after January 21, 2019.

45 CFR §46.116(h) Posting of clinical trial consent form

(1) For each clinical trial conducted or supported by a Federal department or agency, one Institutional Review Board (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 website (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 website 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.

For more information please review the ClinicalTrials.gov Posting Informed Consent Instructions Factsheet

Consistent with the Final Rule, ClinicalTrials.gov has updated the procedures for posting results information submitted for applicable clinical trials (ACTs) as of January 2020. ClinicalTrials.gov will post submitted results information publicly within 30 days of submission, regardless of whether the Protocol Registration and Results System (PRS) quality control (QC) review processes are complete. Records will indicate that the QC process has not concluded and include standard QC review comments on the public facing ClinicalTrials.gov website. 

For more information please review the ClinicalTrials.gov Quality Control and Posting Procedures Factsheet

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)

The Food and Drug Administration (FDA) Amendments Act of 2007 (FDAAA), Title VIII, expands the National Library of Medicine (NLM) clinical trials registry and results database known as ClinicalTrials.gov and requires that a “Responsible Party” (RP) submit clinical trial registration and results information to the ClinicalTrials.gov data bank for certain “applicable clinical trials (ACTs).”  The regulation became effective on January 18, 2017, and Responsible Parties have been required to be in compliance starting April 18, 2017. Applicable Clinical Trials generally include:

1. Trials of Drugs and Biologics: Controlled, clinical investigations, other than Phase 1 investigations, of a product subject to FDA regulation; and
2. Trials of Devices: Controlled trials with health outcomes, other than small feasibility studies, and pediatric post market surveillance.

The consequences of noncompliance may include public notices of noncompliance and violations, withholding of federal funds, FDA sanctions and civil monetary penalties ($13,237 per day).  Civil monetary penalties may be assessed for:

• Failing to submit required clinical trial registration and/or results information to the ClinicalTrials.gov data bank,
• Submitting false or misleading information to the ClinicalTrials.gov data bank,
• Failing to submit the required certification to FDA, or
• Knowingly submitting a false certification to FDA.

The FDA has begun issuing Preliminary Notices of Noncompliance (Pre-Notice) Letters. These Pre-Notice Letters describe the potential violation and requests that the RP take the necessary actions to address the potential violation within 30 calendar days from receipt of the letter.  After 30 calendar days from receipt of a Pre-Notice Letter, the FDA will conduct a further review and assessment of the clinical trial information submitted to ClinicalTrials.gov (and other relevant information available to FDA) to determine if regulatory action is required, inclusive of the issuance of a Notice of Noncompliance, civil money penalties, an injunction, and/or criminal prosecution.

If you receive an FDA Pre-Notice letter, please contact the Research Compliance Office and Integrity Office at ctgov@ucsd.edu or (858) 822-4939, as soon as possible for assistance.

Frequently Asked Questions

The Research Compliance and Integrity (RCI) team is excited to announce we have created the ClinicalTrials.gov Video Series. A collection of videos that walk through each step of registering and posting results on ClinicalTrials.gov. Click on the links below for step-by-step instructions on how to enter the required information for each module:

ClinicalTrials.gov - Registering A New Record

1. Registering A Study
2. Entering Study Identification Information
3. Entering Study Status Information
4. Entering Sponsor and Collaborators Information
5. Entering Oversight Information
6. Entering Study Description Information
7. Entering Conditions Information
8. Entering Study Design Information
9. Entering Arms and Intervention Information - Interventional Study Type
10. Entering Groups and Intervention Information - Observational Study Type
11. Entering Outcome Measures Information
12. Entering Eligibility Information
13. Entering Contacts and Locations Information
14. Entering IPD Sharing Statement Information
15. Entering References Information

ClinicalTrials.gov - Results

1. Preparing to Enter Results on ClinicalTrials.gov
2. Entering Participant Flow Information
3. Entering Baseline Characteristics Information
4. Entering Outcome Measures and Statistical Analysis Plan
5. Outcome Measures FAQ
6. Entering Adverse Events
7. Entering Limitations and Caveats
8. Entering More Information
9. Uploading Study Documents

ClinicalTrials.gov - Tips and Tricks

1. Requesting a User Account on PRS System
2. Updating the Record
3. Delayed Results
4. How to Copy and Change Record Owner
5. Granting Access to records
6. How to Delete a Record
7. Addressing Major and Minor Comments
8. Definitions
9. Spell Check
10. Responsible Party and Principal Investigator
11. Review of PROCoM emails

ClinicalTrials.gov - FDA Webinar Series

1. ClinicalTrials.gov: Part 1 - Meeting Transparency and Reporting Requirements 
2. ClinicalTrials.gov: Part 2 - Definitions, Laws, and Regulations
3. ClinicalTrials.gov: Part 3 - CDER's Compliance and Enforcement Activities

1. ClinicalTrials.gov Resources
   1. ClinicalTrials.gov Frequently Asked Questions (FAQs)
   2. Applicable Clinical Trial (ACT) determination
      1. Detailed ACT definition
      2. ACT Checklist
2. 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
3. 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

• 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