ClinicalTrials.gov Support

Important Notice

ClinicalTrials.gov Updates Delayed Due to Federal Government Shutdown

Investigators may experience temporary delays when submitting changes or releasing records on ClinicalTrials.gov. This affects new registrations, updates, releases, and result postings.

Guidance for Investigators:

Document Your Attempts:

• If you encounter issues in New PRS, try switching to Classic PRS. Similarly, if Classic PRS does not work, try using New PRS.
• If the record still cannot be released, add a note in the Record Log at the bottom of the record page in Classic PRS. Suggested text: [October X, 2025] Attempted to release the record. The system message indicated that the submission may not be processed due to the federal government shutdown. All record information is confirmed accurate and ready for release. Will reattempt when systems resume normal functions.
• Alternatively, you can download the draft receipt to document the date and time of your submission attempt.
• Journal requirements
• If you plan to publish your study in a journal that requires registration in clinicaltrials.gov before the first subject is enrolled, when you submit your manuscript, add a note to the cover letter explaining the situation. Editors have discretion to consider extenuating circumstances.

Features

When you request a consultation, the ORS will help you:

• Determine whether your clinical research study must be registered at ClinicalTrials.gov
• Set up and manage your ClinicalTrials.gov account
• Enter study information

Get Started

To get started, request a consultation with the ORS. 

Determine if Registration is Required

ORS provides guidance in determining whether a clinical research study must be registered on ClinicalTrials.gov, who is responsible for registering, whether study results must be reported, and the deadlines for both registration and results reporting.

While the University of Rochester (UR) encourages registering all human subjects research on a public website. View the UR Policy on Public Disclosure of Clinical Trial Information (updated September 25, 2025).

Registration is required for three reasons:

1. Required by federal law for certain drug, device or biologic studies
2. Required by the NIH for NIH-funded research that is interventional and prospective
3. Required by some journals for publication

Use this decision tree to determine if your study should be registered on ClinicalTrials.gov.

Federal Requirements

Study registration and reporting of results and adverse events are required by federal law for most clinical trials. The FDA Amendments Act of 2007 (FDAAA) requires registration of applicable clinical trials:

• Trials of drugs and biologics: controlled, clinical investigations of a product subject to FDA regulation, other than phase I investigations
• Trials of devices: controlled trials with health outcomes of a product subject to FDA regulation (other than small feasibility studies) and pediatric post-market surveillance studies

Basic results and adverse events must be reported for applicable clinical trials. The consent form for registered clinical trials must include language about registering the study on ClinicalTrials.gov. Please contact your IRB of record for this language.

NIH Requirements

The NIH requires studies that meet their definition of a clinical trial to be registered on ClinicalTrials.gov. The NIH has provided a checklist  to determine if your study is an applicable clinical trial.

Journal Requirements

The International Committee of Medical Journal Editors requires trial registration  as a condition for publication.

Registration & Reporting

Responsible Party

The party responsible for registration and reporting is the clinical trial sponsor or the PI, if the PI meets all of the following criteria:

• Is designated by the sponsor
• Is responsible for conducting the trial
• Has access to and control over trial data

Investigators should confer with the study sponsor to determine who is the responsible party and to ensure that the study is registered at ClinicalTrials.gov (and only once). If a non-UR sponsor delegates responsibility to UR faculty, registration must be managed within the non-UR sponsor's ClinicalTrials.gov account.

Responsible parties who fail to register or who submit false or misleading information will incur significant penalties, which may include civil monetary penalties or withholding or recovery of grant funds for federally-funded trials.

When to Register

The law and the NIH require registration within 21 days of first subject enrollment. However, the International Committee of Medical Journal Editors requires registration before any subjects are enrolled. To meet both legal and publishing requirements, University policy requires registering in the ClinicalTrials.gov database prior to first subject enrollment.

When to Report Results

FDAAA and the NIH require reporting of study results for applicable clinical trials no later than 12 months after the date of final data collection for the primary outcome measure, referred to as the “primary completion date.” Results reporting can be delayed beyond the 12-month required timeline if:

• The trial is of a drug or device that has not been approved for marketing by the FDA for any indication, in which case results must be reported within 30 days of initial approval
• The trial is of a drug or device for which the manufacturer has filed or is preparing to file an application seeking approval of the new use studied in the trial
• A request for delay that “demonstrates good cause” has been granted by the director of the NIH

At this time, the International Committee of Medical Journal Editors does not require reporting study results in the ClinicalTrials.gov database. ORS recommends that PIs stay informed about these requirements, as they evolve.

ClinicalTrials.gov Account Management

ORS holds the UR institutional administrator account for the ClinicalTrials.gov Protocol Registration System (PRS) and provides guidance and management to all account holders within the system. In the UR process, there are two additional account types, group administrator and group user, which must be occupied by two different parties. A group user who creates a PRS record and maintains registration data should not also be the group administrator who reviews and releases the record to the PRS.

Group Administrator

Each department or center within the University that has faculty who are required to register studies at ClinicalTrials.gov must designate one or more group administrators. ORS establishes user IDs for these administrators, grants them administrative privileges within the PRS, and provides assistance to familiarize them with the PRS and with their responsibilities, which include:

• Managing group user accounts
• Reviewing and ensuring release of data entered into study-registration records created by group users
• Ensuring group user attention to PRS system messages

Group User

An individual investigator (the responsible party) or their designee should contact the assigned group administrator to receive a PRS user ID. The group user enters data regarding the study into the PRS.

Technical Assistance

ORS can provide technical assistance for the entry and release of required study information, including study registration and reporting results and adverse events.

Resources

Detailed information and instructions about registration, required data elements, results reporting and adverse events reporting can be found through the following links:

• Background and FAQs
  • Training Material
  • How to register your study
  • FAQ
  • What NIH Grantees Need to Know about FDAAA
• Guidance for Results and Adverse Events Reporting
  • "Basic Results" Data Element Definitions (DRAFT)
  • How to submit your results

Contact

Joan E. Adamo, Ph.D., Director, Regulatory Support
Joan_Adamo@urmc.rochester.edu, (585) 275-0742

Reshma Ravilla, Pharm.D., Regulatory Affairs and Compliance Specialist
Reshma_Ravilla@urmc.rochester.edu

Carrie Dykes, Ph.D., Research Engagement Specialist
Carrie_Dykes@urmc.rochester.edu,  (585) 275-0736

Shelby Johnson, Administrative Support
Shelby_Johnson2@urmc.rochester.edu, (585) 275-5327