Support for ClinicalTrials.gov Study Registration
The Office of Regulatory Support (ORS) offers services to support research teams with registration and reporting of clinical research trials at ClinicalTrials.gov, a database of clinical research trials conducted in the United States and around the world. Please submit a request through our Research Request Dashboard to set up a clinicaltrials.gov account or register your study. The University of Rochester Policy on Public Disclosure of Clinical Trial Information (Clinical Trials.gov) can be found here.
Determination of Registration Requirements
ORS provides guidance in determining whether a clinical research trial must be registered, who is responsible for the registration, whether study results must be reported and the deadlines for both registration and results reporting.
While the University of Rochester encourages registering all human subjects research in a public website, 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.
- Study Registration and Reporting Required by Federal Law.
Study registration and reporting of results and adverse events are required by federal law for most clinical trials. U.S. Public Law 110-85 (Food and Drug Administration Amendments Act of 2007 or FDAAA) requires registration of "Applicable Clinical Trials:" Trials of Drugs and Biologics: Controlled, clinical investigations, other than Phase I investigations, of a product subject to FDA regulation;
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.
A helpful flow chart to identify an "Applicable Clinical Trial" is here. Click here for complete statutory definitions and more detailed information about their meaning.
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.
2. Study Registration and Reporting Required by the NIH:
The NIH now requires studies that meet their definition of a clinical trial to be registered on clinicaltrials.gov. The NIH has also provided this pdf checklist to determine if your study is an applicable clinical trial. This checklist should only be used for studies that will start on or after January 18, 2017.
3. Registration Requirements by some journals
The International Committee of Medical Journal Editors (ICMJE) also requires trial registration as a condition for publication. Click here for more details about ICMJE requirements.
Guidance for Basic Experimental Studies with Humans (BESH) Funding Opportunities
Need help determining if your study falls within a Basic Experimental Studies with Humans (BESH) funding opportunity announcement? This link has key considerations and associated examples to help you.
The party responsible for registration and reporting is:
The sponsor of the clinical trial OR the principal investigator (PI), if the PI:
- Is designated by the sponsor; and
- Is responsible for conducting the trial; and
- Has access to and control over the data
A helpful flow chart to determine the Responsible Party is here.
Investigators should confer with the study sponsor to determine who the responsible party is, and to ensure that the study is registered at ClinicalTrials.gov once, and only once. If a non-University of Rochester (UR) Sponsor delegates responsibility to UR faculty, registration must be managed within the non-UR Sponsor's ClinicalTrials.gov account.
Penalties for responsible parties who fail to register or who submit false or misleading information are significant, and may include civil monetary penalties and, for federally-funded trials, the withholding or recovery of grant funds.
When to Register
The law and the NIH require registration is to occur within 21 days of first subject enrollment. However, ORS recommends trial registration in the ClinicalTrials.gov database prior to first subject enrollment, to satisfy both the law and ICMJE requirements. ICMJE requires registration before any subjects are enrolled.
When to Report Results
FDAAA and the NIH requires 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.”
Reporting of results 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; result reporting will be required 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; or
- A request for delay that “demonstrates good cause” has been granted by the Director of the NIH.
At this time, the ICMJE does not require the recording of study results in the ClinicalTrials.gov database. ORS recommends that PIs stay informed about these requirements, as they evolve.
Assistance with ClinicalTrials.gov Account Management
ORS holds the University of Rochester (UR) Institutional Administrator account for the ClinicalTrials.gov Protocol Registration System (PRS), and provides guidance and management to all account holders within the PRS. Within the UR process, there are two additional account types:
Each department or center within UR, with faculty who are required to register studies at ClinicalTrials.gov, designates one or more Group Administrators.
ORS establishes user IDs for these administrators and grants them administrative privileges within the PRS. The ORS provides necessary assistance to familiarize Group Administrators 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
An individual investigator (the Responsible Party), or their designee, contacts the assigned Group Administrator to receive a PRS User ID. The Group User enters data regarding the study into the PRS.
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.
Technical Assistance with Entry of Study Information
ORS can provide technical assistance to support the entry and release of required study information, including study registration, results reporting and adverse events reporting.
Other Useful Information:
The Clinicaltrials.gov Final Rule becomes effective January 18, 2017. For more information about the changes, watch the CTSI update seminar here. You will need to log in with your NetID and password.
The NIH has also provided three webinars that cover all the changes in detail.
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: