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External Database Reporting

Clinical Trials

National Institutes of Health (NIH)

Clinical Trial Definition 

A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.

Registration & Reporting Requirements 

Registration:

Within 21 days of first enrollment.

Reporting:

No later than 12 months after primary completion date.

Penalties 

Loss of grant funding or future funding may be affected.

Food & Drug Administration (FDA)

Applicable Clinical Trial Definition 

Drugs & Biologics:

controlled clinical investigations, other than Phase 1 of products subject to FDA regulation
Devices:

  1. controlled trials with health outcomes of devices subject to FDA regulation, other than small feasibility studies
  2. pediatric postmarket surveillance as required by FDA.

Registration & Reporting Requirements 

Registration:

Within 21 days of first enrollment.

Reporting:

No later than 12 months after primary completion date.

Penalties 

Civil monetary penalties up to $11,383 per day until noncompliance is resolved.

NIH funded clinical trials require registration per NIH policy.

If the answer is “yes” to all four of the following questions, then the research study meets the NIH definition of a clinical trial and must be registered. 

  • Does the study involve human participants?
  • Are the participants prospectively assigned to an intervention (placebo or control)?
  • Is the study designed to evaluate the effect of the intervention on the participants?
  • Is the effect being evaluated a health-related biomedical or behavioral outcome?

Use the NIH Decision Tool to help determine if your study meets the NIH definition of clinical trial.

Applicable clinical trials, regardless of funding source, must be registered (42 CFR Part 11). ACTs generally include: 

  • Controlled clinical trials of FDA-regulated drugs or biologics (Phases II – IV) 
  • Controlled clinical trials and pediatric post-market surveillance of FDA-regulated devices (other than small feasibility studies) 
  • Research studies testing a clinical hypothesis about health outcomes, including:   
    • research whose primary purpose is to affect clinical practice   
    • nutritional studies 

Regardless of the funding status or source for a clinical trial involving human subjects, the UTEP IRB recommends following the compliance practices required by NIH as a best practice. Publication in certain journals could be jeopardized if researchers do not comply with these best practices.

Who should register?

The “Responsible Party” is responsible for registering a clinical trial. At UTEP, the PI is the Responsible Party with some exceptions:

  • If there is an IND or IDE held by someone else, the IND or IDE holder is the Responsible Party 
  • Multi-site studies typically designate the lead institution as the Responsible Party 
  • The Responsible Party is required to ensure that study registration, required record updates, and results reporting are completed in a timely manner, according to HHS regulations and federal policy. 

When to register?

Federal regulations and NIH policy require new qualifying trials/studies to register no later than 21 days after the first participant is consented.

Where to register?

ClinicalTrials.gov is the primary database for registering and reporting clinical trial results.

ClinicalTrials.gov

How to register?

Request an individual account to the ClinicalTrials.gov Protocol Registration and Results Submission System (PRS). A PI, or any administrator who will assist the PI, should each obtain an individual account.

Contact
irb@utep.edu

Include name, school/college, department, email address, and IRBNet project number.

After the request is processed, a log-in name and temporary password will be sent by email from ClinicalTrials.gov.

In general, the Responsible Party must review and update an active study record at least once every 12 months. Failure to do so will result in the record being identified as having a problem that needs to be addressed.

Federal policy requires updates to any relevant clinical trial information must be submitted no later than 30 calendar days after the amendment is approved by the IRB if changes are communicated to human subjects.

Find out more

Federal regulations and the NIH policy require reporting of results for Applicable Clinical Trials (ACT), Probably Applicable Clinical Trial (pACT) and NIH funded clinical trials. The Responsible Party is required to report results information for a registered clinical trial no later than one year after the Primary Completion Date identified in the registration record.

The Primary Completion Date is the “date the last subject was examined or received an intervention to collect final data for the primary outcome measure” of the study. The PI and/or study statistician should be involved in preparing results for reporting to ensure the information is accurately summarized and in the format required by law.

All of Us

The All of Us Research Program is building a dataset to help transform the future of health research by equipping researchers with expansive health data shared by a diverse participant cohort. The All of Us dataset is disease agnostic and can support research on many aspects of health.

More than 12,000 health researchers are already leveraging this one-of-a-kind dataset to improve understanding of health and disease, identify opportunities to reduce disparities, and enable more precise approaches to care.

UTEP has signed a Data Use and Registration Agreement (DURA)

This allows UTEP affiliated researchers the ability to register and access the All of Us Researcher Workbench.

The Workbench offers access to additional levels of data, workspaces, a cohort builder, and an interactive notebook environment.

If you require access to the Workbench

PIs must have an active IRB to access the registered and controlled tiers of access.

UTEP will be notified when a researcher creates a researcher account in All of Us and requests controlled tiers of access. HRPP will verify that you have an active protocol and that protocol requests "access to the All of Us database". You will be granted access when verified.

External Data Repositories

There are many calls from research organizations to make data available in open-source data repositories. UTEP has no policy forbidding the sharing of de-identified data to data repositories. 

One potential hurdle that a PI might encounter is due to the requirement of participant consent for future data use. This requirement is usually met by including the consent for future data use at the acknowledgement or approval areas of informed consent. 

Posting de-identified data for public access is allowable, provided participants in the original research consent to future data use.