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
Meg Johnson, JD, CIP	Director, Conflicts of Interest and Research Integrity	959.262.4139	meg.johnson@uconn.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.

Enhancing interdisciplinary research is a strategic goal for the University. An important component of this is the strengthening the inter-campus collaborations between Storrs and UConn Health. We can assist faculty in preparing and submitting externally funded inter-campus proposals and awards.

Because UConn (Storrs) and UConn Health are two separate fiscal entities, proposals seeking extramural funds are administered similar to sponsored activity involving any other inter-institutional collaborations – where one institution serves as the lead applicant and the other consortium partner acts as the subawardee.

At the proposal stage, the external funding agency will typically require a statement of commitment from each collaborating organization to ensure that there is appropriate programmatic and administrative support and oversight.

In order for Sponsored Program Services  (SPS) at Storrs and  Sponsored Program Services (SPS) at UConn Health to approve a Letter of Intent/Consortium Statement, both the lead organization and subawardee proposals need to be routed, reviewed and approved by the respective academic and administrative offices.

• Lead Organization: One campus is the lead organization; the other campus participating in the project is the subawardee. The decision regarding which campus serves as the lead applicant typically is dictated by the scope of the project – the lead organization performs a substantive role in conducting the project and maintains appropriate oversight of all scientific, programmatic, financial, and administrative matters related to the grant.
• Budgets: The subawardee’s proposed costs (direct and F&A) get rolled-up into the lead organization’s budget. Each site (Storrs or UConn Health) applies and receives its respective F&A costs. The lead organization waives F&As associated with the first $25K of the inter-campus subaward.  Subawardee personnel cannot be included as personnel in the lead organization’s budget.
• Internal Review/Approval by the Subawardee Organization: At least 10 business days before the funding agency’s deadline, the subawardee principal investigator needs to submit internal forms (Storrs or UConn Health  routing and significant financial interest, scope of work, budget and budget justification plus any additional documents requested to the subawardee’s sponsored programs office [Storrs SPS or UCH SPS]). After review and approval by that office, the subawardee investigator will submit the approved consortium statement, scope of work, budget and budget justification plus any additional requested documents to the lead organization’s principal investigator.
• Internal Review/Approval at the Lead Organization: The principal investigator for the lead organization should route the complete application to his/her respective sponsored programs office, using the normal review, compliance, and approval processes and by that office’s stated deadline.

Staff Contacts

• Storrs / Forms
• UCH / Forms

Roles and Responsibilities

The eRA Commons system is an online interface where grant applicants, grantees, and grantor agencies can access and share administrative information relating to research grants as they are received by NIH via Grants.gov. The eRA system allows Principal Investigators to track their applications; view summary statements and score letters; view notice of awards; submit just in time information; access eSNAP Progress Reports, Financial Status Reports and final closeout reports; and no-cost extensions.

SPS provides access to eRA Commons registration, a condition that must be met before initiating a NIH proposal. To register for an eCommons account, you must complete the NIH eCommons Account Registration Form below. If you already have an ID and password, click on the link below to login to eRA Commons.

NIH & Grants.gov

UConn Health is already registered with Grants.gov. Investigators and departmental personnel need not register. NIH provides guidance on submitting applications through Grants.gov at the following sites:

 

Instructions for Routing NIH Proposals via Grants.gov. Internal paperwork must be routed through SPS before it is submitted electronically through Grants.gov.

1. The routing process should be initiated 3-5 business days before the deadline date. This allows SPS time to review and approve the proposal prior to submission.
2. The proposal will not be submitted electronically to NIH until SPS receives, reviews, and approves the complete proposal package, including the routing form, budget, consortium documents, and a copy of the application package (or access to the application in ASSIST).

The PI does not submit the proposal to NIH. Only SPS has the authority to submit the proposal to NIH after receiving full access permission from the PI.

1. The PI will complete the electronic application and email to preaward@uconn.edu.
2. SPS will print the application, review for compliance with application instructions and request additional information and/or corrections as necessary.
3. The PI will be notified when the application has been reviewed and approved.
4. The final version must be reviewed prior to submission.

 

The Principal Investigator may submit a draft application to SPS for review and approval. The PI may submit draft attachments in the application for review and continue to update their science during the review process.The final application should be submitted to SPS 2 business days before the deadline date.

Do not wait until the last minute to deliver the final proposal package.

The grants.gov server has been known to “bog down,” particularly on deadline dates. This may result in missing the deadline.

Remember: Submission to Grants.gov and the NIH is a multi-step process. Grants.gov processes a series of validations prior to sending the application to the NIH. NIH, in turn, processes a series of business process validations prior to accepting the application.

A series of email messages will be sent to the PI and SPS when the proposal is submitted via Grants.gov.

The PI must have an eRA Commons account in order for the application to be validated by NIH. Once an application completes validation by Grants.gov, it is sent to the NIH. In order for the application to be validated by the NIH, each PI must have an eRA Commons account (Credential Log-In).

If the application meets NIH validation requirements, the application is posted in eRA eCommons. The PI needs to check the assembled application in eRA Commons to ensure the application is complete and has no system conversion issues. If the application did not meet NIH validation requirements and errors were generated, a corrected application must be submitted prior to the submission deadline. If warnings were generated upon validation and the PI would like to address, the previous application must be rejected and a corrected application must be submitted prior to the submission deadline.

 

Additional information for NIH submission:

• NIH Website
• Program Deadlines
• Unsolicited Program Applications – Parent Announcements
• NIH Policies and Guidance
• News from NIH