Support for ClinicalTrials.gov Study Registration
The Office of Regulatory Support (ORS) helps research teams register and report their clinical research studies at ClinicalTrials.gov, an online database of clinical research studies that provides trial information and results to the public, researchers, and health care professionals. We can help you determine whether a clinical research study must be registered and assist with registration and reporting results.
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), registration is required for three reasons:
- Required by federal law for certain drug, device or biologic studies
- Required by the NIH for NIH-funded research that is interventional and prospective
- 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.
Basic Experimental Studies with Humans (BESH) are studies that meet both the federal definition of basic research and the NIH definition of a clinical trial. However, NIH has delayed the enforcement for ClinicalTrials.gov registration and results reporting for BESH studies until September 24, 2024. If you need help determining if your study falls within a BESH funding opportunity, review our BESH guidance document.
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, ORS recommends 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
- Guidance for Results and Adverse Events Reporting
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