General FAQ
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.
Whom should I contact with general questions about the Clinical Trials Innovation Unit? You can reach the CTIU at 501-686-8572.
Who may use the Clinical Trials Innovation Unit? The Clinical Trials Innovation Unit 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 Clinical Trials Innovation Unit but should identify a faculty mentor. In addition, the Clinical Trials Innovation Unit supports investigators at Arkansas Children’s Hospital and its Research Institute, and the Central Arkansas Veterans Healthcare System (CAVHS).
What types of research are supported by the CTIU? The CTIU supports human-based research regardless of the funding source (e.g., federal, private foundation and industry funding).
Does the CTIU support industry-sponsored trials? Yes, the CTIU will support pharmaceutical investigations.
Financial and Regulatory FAQ
Is there a cost for using coordinator and regulatory support?
Yes, to determine costs, a feasibility assessment is conducted and may require a meeting with the investigator and other members of the study team. For industry sponsored research studies, the CTIU will negotiate coordinator and regulatory support costs with the sponsor. For grant proposals, CTIU support will need to be built into the grant’s budget. Early CTIU involvement in the study startup process will help maximize the potential to start the study in a timely manner.
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.
What if there are revisions to the original, approved protocol or consent? Amended protocols and consents must be submitted and approved by the required regulatory bodies before subjects can be enrolled. If revisions effect the cost to conduct the study, a budget modification must be submitted, and the budget may need to be renegotiated. The CTIU Finance Team can assist with this process.
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 principal 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.