Whom should I contact with general questions about the Translational Research Institute (TRI)?
You can reach TRI at 501-614-2287 or TRI@uams.edu. To request research services or resources, please use the TRI Services Portal.
What is Translational Research?
Learn how TRI conceptualizes translational research.
How should I acknowledge support received from TRI?
Learn what constitutes TRI support and find suggested citation language.
Do publications arising from research supported by TRI need to include an acknowledgment statement?
Yes, any publication representing research supported by TRI is required to cite the Translational Research Institute, award UL1TR000039.
Who may use the Clinical Trials Innovation Unit (CTIU)?
The Clinical Trials Innovation Unit (CTIU) is available to all UAMS faculty members, including those with adjunct appointments. A physician collaborator may be required for protocols in which the principal investigator is not a medical doctor. Fellows and doctoral students are encouraged to use the CTIU but should identify a faculty mentor. In addition, the CTIU supports investigators at Arkansas Children’s Hospital and its Research Institute, and the Central Arkansas Veterans Healthcare System (CAVHS).
Whom should I contact with general questions about the Clinical Trials Innovation Unit (CTIU)?
You can reach the Clinical Trials Innovation Unit (CTIU) at 501-526-7665.
How do I know if my study needs to be submitted to Novitas-Solutions or Centers for Medicare and Medicaid Services (CMS)?
Device studies that were approved by the FDA on or after Jan. 1, 2015, must be submitted for review and approval to CMS by the sponsor if seeking Medicare. Device studies approved by the FDA prior to Jan. 1, 2015, must be submitted to Novitas-Solutions (UAMS’ Medicare Administrative Contractor) by the site.
Does Novitas-Solutions approve studies using a Humanitarian Use Device (HUD) or Humanitarian Device Exemption (HDE)? Does Medicare have specific regulations regarding HUDs?
Novitas-Solutions does not review HUD or HDE for approval. Medicare has no specific rules, regulations or instructions with regard to HUDs. Medicare does not require nor is there any process for obtaining prior approval for HUDs. Furthermore, Medicare does not perform “prior authorizations” for insertion of these devices. Additionally, coverage under general Medicare rules (see Social Security Act, Section 1862 (a)(1)(A) Medically Reasonable & Necessary) indicates most HUDs are not covered by Medicare.
Clinical Research Team (CRT) FAQ
What types of research are supported by the CRT?
The CRT supports human-based research regardless of the funding source (e.g., federal, private foundation and industry funding).
Does the CRT support industry-sponsored trials?
Yes, the CRT will support pharmaceutical investigations.
Is there a cost for using CRT services?
Yes, but we do offer some services (listed below) for free. In 2011, the Clinical Research Team became a fee-for-service core to ensure that UAMS sustains the necessary infrastructure for conducting research. Investigators are encouraged to contact the CRT at the beginning of grant or protocol development or prior to budget negotiations for industry sponsored research studies. All service requests and questions may be submitted through the TRI Services Portal by clicking on the Request Services button at the top of this page. There is no cost for utilizing protocol development, budget review, budget development, budget negotiations, and Medicare coverage analysis services.
What if there are revisions to the original, approved protocol or consent?
Amendments and modified protocols must be submitted and approved by the required regulatory bodies before subjects can be enrolled in the revised protocol. In addition, a revised Resource Request Form will be required if the modifications affect CRT services.
What is a Clinical Trial?
ClinicalTrials.gov explains that a clinical trial involves research using human volunteers (also called participants) that is intended to add to medical knowledge. In a clinical trial, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or changes to participants’ behavior, such as diet. Clinical trials may compare a new medical approach to a standard one that is already available, to a placebo that contains no active ingredients, or to no intervention. Some clinical trials compare existing interventions to each other. When a new product or approach is being studied, it is not usually known whether it will be helpful, harmful, or no different than available alternatives (including no intervention). The investigators try to determine the safety and efficacy of the intervention by measuring certain outcomes in the participants.
What is a Confidential Disclosure Agreement (CDA)?
A CDA is a legal document that ensures confidentiality of proprietary information that a sponsor gives to the principle investigator. A signed, study specific CDA may be required before a sponsor will provide its proprietary information, such as the study protocol, to an investigator. The CTIU helps facilitate this process.