1. Request an account by emailing Ellen Ciesielski, UConn/UConn Health’s ClinicalTrials.gov PRS Administrator. You will be sent an automated email from the PRS system with your username and password.

2. On the PRS log-in page, in the Organization field, enter “UConnHealth” (no spaces) if your account was created under UConn Health or “UConn” if your account was created under UConn.

3. Click on the blue “Create New Record” button on the far right of the page. The system will walk you through the creation of the record. Data entered on previous pages will be retained so that you can return to complete the record at a later date.

The person who creates the record is the “Record Owner.” The Record Owner may be the Principal Investigator (PI) or someone designated by the PI to create/update the record on his/her behalf. The PI must perform the final review and approval of the record and each subsequent update in the PRS. The PI is responsible for ensuring that accurate information about the trial is entered and that updates to the record are completed in a timely manner (see table below for specific deadlines).

Complete the below fields as follows:

1. 1. • Organization’s Unique Protocol ID: Enter the IRB number.
      • Secondary IDs: Enter the grant number.
      • Record Verification Date: Enter the month and year in which you are completing the record. This field will need to be updated each time you update the record after it is registered.
      • Primary Completion Date: Enter the anticipated final data collection date, specifically regarding the Primary Outcome Measure.
      • Responsible Party: Select the Principal Investigator from the drop-down menu.
      • Collaborators: Add any other organizations providing support, including funding, design, implementation, data analysis and reporting.

For studies reviewed by UConn Health:

1. 1. • Board Name: UConn Health IRB
      • Board Affiliation: UConn Health
      • Board Contact phone and e-mail: 860.679.8729; irb@uchc.edu
      • Board Contact Address:  UConn Health IRB, 263 Farmington Avenue, Farmington, CT 06030-1511

For studies reviewed by UConn Storrs and Regional Campuses:

1. 1. • Board Name: UConn IRB
      • Board Affiliation: UConn
      • Board Contact phone and e-mail: 860.486.0986; irb@uconn.edu
      • Board Contact Address: UConn IRB, 438 Whitney Road Extension, Unit 1246, Storrs, CT 06269

The Final Rule dictates that ClinicalTrials.gov record fields are updated on the below schedule:

Data Field	Deadline for Updating (i.e., not later than the specified date)
Study Start Date	30 calendar days after the first subject is enrolled (if the first human subject was not enrolled at the time of registration).
Intervention Name(s)	30 calendar days after a nonproprietary name is established.
Availability of Expanded Access	30 calendar days after expanded access becomes available (if available after registration); and 30 calendar days after an NCT number is assigned to a newly created expanded access record.
Expanded Access Status	30 calendar days after a change in the availability of expanded access.
Expanded Access Type	30 calendar days after a change in the type(s) of available expanded access.
Overall Recruitment Status	30 calendar days after a change in overall recruitment status. If Overall Recruitment Status is changed to “suspended,” “terminated,” or “withdrawn,” the Why Study Stopped data element must be submitted at the time the update is made.
Individual Site Status	30 calendar days after a change in status of any individual site.
Human Subjects Protection Review Board Status	30 calendar days after a change in status.
Primary Completion Date	30 calendar days after the clinical trial reaches its actual primary completion date.
Enrollment	At the time the primary completion date is changed to “actual,” the actual number of participants enrolled must be submitted.
Study Completion Date	30 calendar days after the clinical trial reaches its actual study completion date.
Responsible Party, by Official Title	30 calendar days after a change in the responsible party or the official title of the responsible party.
Responsible Party Contact Information	30 calendar days after a change in the responsible party or the contact information for the responsible party.
Device Product Not Approved or Cleared by U.S. FDA	15 calendar days after a change in approval or clearance status has occurred.
Device Product Not Approved or Cleared by U.S. FDA	15 calendar days after a change in approval or clearance status has occurred.
Record Verification Date	Any time the responsible party reviews the complete set of submitted clinical trial information for accuracy and not less than every 12 months, even if no other updated information is submitted at that time.

Over the past two decades, government agencies and the International Committee of Medical Journal Editors (ICMJE) have issued laws and directives on the subject of clinical trial registration. All parties have consistently agreed that the purpose of trial registration is to promote the public good by ensuring that the existence and design of clinical trials are publicly available. The registration effort began with the development of a publicly available website, ClinicalTrials.gov, a service of the National Institutes of Health (NIH), developed by the National Library of Medicine.

In 1997, the Food and Drug Administration (FDA)/NIH began requiring registration for only a limited number of trials. Then in September 2007, the FDA Amendments Act (Title VIII. Sec. 801) significantly expanded the scope of clinical trials that must be registered and set civil monetary penalties for failing to register “applicable trials.” In 2004, the ICMJE defined trials that must be registered in order to be considered for publication in journals that adhere to ICMJE standards. In 2007, the ICMJE expanded the definition of trials that must be registered. Scores of journals (not limited to medical journals) have adopted the registration policy. In 2016, the final rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11), which clarifies and expands the requirements in FDAAA 801, was released, and the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information was published.

The bottom line:
The FDA, NIH and the ICMJE each have their own requirements for registration, and while some of the requirements overlap, there are some differences. In order to comply with the law and preserve the ability to publish in many journals, all sets of requirements must be met. UConn Health is committed to supporting Principal Investigators (PIs) with meeting the requirements concerning the public availability of clinical trial data in ClinicalTrials.gov, as outlined in our University ClinicalTrials.gov policy.

How is “clinical trial” defined and what are the registration deadlines?

According to NIH:

A clinical trial is a research study¹  in which one or more human subjects² are prospectively assigned³ to one or more interventions⁴ (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.⁵  All clinical trials must be registered within 21 days of enrollment of the first participant.

¹See Common Rule definition of research at 45 CFR 46.102(d).

²See Common Rule definition of human subject at 45 CFR 46.102(f).

³The term “prospectively assigned” refers to a pre-defined process (e.g., randomization) specified in an approved protocol that stipulates the assignment of research subjects (individually or in clusters) to one or more arms (e.g., intervention, placebo, or other control) of a clinical trial.

⁴An intervention is defined as a manipulation of the subject or subject’s environment for the purpose of modifying one or more health-related biomedical or behavioral processes and/or endpoints.  Examples include:  drugs/small molecules/compounds; biologics; devices; procedures (e.g., surgical techniques); delivery systems (e.g., telemedicine, face-to-face interviews); strategies to change health-related behavior (e.g., diet, cognitive therapy, exercise, development of new habits); treatment strategies; prevention strategies; and, diagnostic strategies.

⁵Health-related biomedical or behavioral outcome is defined as the pre-specified goal(s) or condition(s) that reflect the effect of one or more interventions on human subjects’ biomedical or behavioral status or quality of life.  Examples include:  positive or negative changes to physiological or biological parameters (e.g., improvement of lung capacity, gene expression); positive or negative changes to psychological or neurodevelopmental parameters (e.g., mood management intervention for smokers; reading comprehension and /or information retention); positive or negative changes to disease processes; positive or negative changes to health-related behaviors; and, positive or negative changes to quality of life.

Registration Deadline: The NIH Policy on Dissemination of NIH-funded Clinical Trial Information applies to applications for funding submitted to NIH on or after 1/18/17. Registration is required no later than 21 days after the first patient is enrolled. The consent form for the trial is required to include the following language: “A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law.  This Website will not include information that can identify you.  At most, the Website will include a summary of the results.  You can search this Website at any time.”

According to the ICMJE:

A clinical trial is any research project that prospectively assigns people or a group of people to an intervention, with or without concurrent comparison or control groups, to study the cause-and-effect relationship between a health-related intervention and a health outcome. Health-related interventions are those used to modify a biomedical or health-related outcome; examples include drugs, surgical procedures, devices, behavioral treatments, educational programs, dietary interventions, quality improvement interventions, and process-of-care changes. Health outcomes are any biomedical or health-related measures obtained in patients or participants, including pharmacokinetic measures and adverse events. Those who are uncertain whether their trial meets the expanded ICMJE definition should err on the side of registration if they wish to seek publication in an ICMJE journal.

Registration Deadline: Registration at or before the time of first patient enrollment is as a condition of consideration for publication in an ICMJE journal.

According to the FDA:

The U.S. Department of Health and Human Services in September 2016 issued a final rule that specifies requirements for registering certain clinical trials and submitting summary results information to ClinicalTrials.gov. The new rule expands the legal requirements for submitting registration and results information for clinical trials involving U.S. Food and Drug Administration-regulated drug, biological, and device products. The FDA Amendments Act (Title VIII. Sec. 801) requires registration for all “applicable clinical trials,” regardless of funder, that are:

1. Trials of drugs and biologics: Controlled, clinical investigations, other than Phase I investigations, of a product subject to FDA regulation, and
2. Trials of devices: Prospective clinical studies of health outcomes comparing an intervention with a device against a control in human subjects (other than small clinical trials to determine the feasibility of a device, or clinical trials to test prototype devices where the primary outcome measure relates to feasibility and not to health outcomes); and pediatric postmarket surveillance studies, as required under the Federal Food, Drug and Cosmetic Act.

Registration Deadline: The FDA Amendments Act of 2007 requires that all trials, regardless of sponsor, must be registered in full no later than 21 days after the first patient was enrolled.

Who is responsible for registering a trial?

The PI is ultimately responsible for determining that registration requirements are met. Although some industry sponsors will do the actual registration work, it is still the PI’s responsibility to ensure that the registration has been accomplished and is accurate.

What are the penalties for failing to register?

According to the ICMJE:

Unregistered trials will not be considered for publication in journals that adhere to ICMJE standards. Questions about policies of a specific journal should be addressed to that journal directly.

According to the FDA/NIH:

Penalties may include civil monetary penalties up to $14,724 fine for failing to submit or for submitting fraudulent information to ClinicalTrials.gov. After notification of noncompliance, the fine may go up to $14,724 per day until resolved. For federally-funded grants, penalties may include the withholding or recovery of grant funds.

Who can help with questions about meeting the requirements?

To comply with University policy regarding ClinicalTrials.gov, please direct any questions to the local Protocol Registration and Results System (PRS) Administrator for UConn/UConn Health, Ellen Ciesielski, Research Integrity & Compliance. The local PRS Administrator serves as a point of contact for resolving requests by ClinicalTrials.gov and regularly monitors to promote compliance with the requirements.

 

 

Research IT Services in the Office of the Vice President for Research supports a wide array of services and is a key player in shaping the future of research at the University of Connecticut.

We have embarked on a bold initiative to modernize and boost our portfolio of software solutions in an effort to reduce the administrative burdens on our researchers and make it easier for them to access and monitor their research activity and information.

A full suite of enterprise applications will provide a template for grant proposal development, automate routing and allow for electronic submission to certain sponsors. In addition, it will provide functionality for awards management; human and animal subjects protocol development and review; financial conflict of interest disclosures; effort reporting and commitment management; and core facility management (research store).

eRA Help Desk

We have coined our initiative to modernize our Enterprise Research IT systems and automate research administration functions the electronic Research Administration, or eRA. We have created the eRA Help Desk to assist you with your questions and technical problems. The eRA Help Desk’s contact information is listed below.

eRA Help Desk

Telephone: 860-486-7944
Email: eRA-support@uconn.edu
Staffed 8:00 AM – 4:30 PM Weekdays

Self-Service Portal: https://it.research.uconn.edu/SelfService (secured with UConn NetID) Don’t know your NetID?

Name	Title	Phone	Email
Michael Centola, MHS, CIP	Associate Vice President for Research Integrity	860.205.3702	centola@uchc.edu

 

Name	Title	Phone	Email
Bieu Tran	Export Control Officer	860.486.3994	bieu.tran@uconn.edu
Export Control	General Mailbox	860.486.3994	exportcontrol@uconn.edu

NOTICE as of 5/05/2025: Due to the need to reserve funds for the recently announced EMERGE emergency funding program, all FY26 OVPR Internal Funding Programs are on hold for at least the first few months of the new fiscal year-we will provide updates as more information becomes available.

The Office of the Vice President for Research (OVPR) SPARK Technology Commercialization Fund aims to support innovative proof-of-concept studies seeking to translate research discoveries into products, processes, and other commercial applications. We invite proposals from across all disciplines for projects related to commercialization activities. We are eager to identify and support UConn-developed inventions and technologies that address unmet needs and have potential for commercial application.

To learn more about the SPARK Technology Commercialization Fund, visit the OVPR Storrs site.

 

The Office of the Vice President for Research (OVPR) is your home for all industry-sponsored research activities.

Contact us.  Bring us in early. We are here to help!

We would like to work with you and your industry partners to ensure that our collaborative research discussions are productive, that negotiations are successful, and that both parties’ needs are met.  We also ensure that agreements are in accordance with University policies and procedures as well as federal regulations and requirements.

We’ve prepared a document that outlines our philosophy and that may be useful to share with your industrial partners.