Clinical Research Coordination & Facilities clif 2017-07-13T08:36:18+00:00
Clinical Research Coordination & Facilities
The Clinical Research Team (CRT) of the Clinical Trials Innovation Unit (CTIU) provides a wide array of coordinator services and resources, include nursing support, research coordinator assistance, regulatory assistance, participant recruitment, specialized research space & lab processing, mobile support and more. Clinical research coordination activities are fee-based services. 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. However, the CRT is available to help investigators at any point during the course of a research study. CRT coordinator services are available for both investigator-initiated and/or industry sponsored research studies. The TRI does charge a fee for these services. Investigators can request CRT coordinator services through the TRI Services Portal.
Once a request is made through the TRI Services Portal, a member of the CRT will contact the investigator to discuss research needs. After this, investigators may be required to complete a form in UCore so services can be tracked. The CRT will then conduct a feasibility assessment and may require a meeting with the investigator and other members of the study team. Once CRT support is determined investigators will be sent a cost-estimate of CRT services to be provided.
For industry sponsored research studies, the CRT will be available to discuss and help negotiate CRT service costs with the sponsor. For grant proposals, CRT services will need to be built into the grant’s budget. Earlier CRT involvement in the study startup process will help maximize the potential to start the study in a timely manner.
All CRT members are up-to-date on HIPAA, Human Subjects Protection, Good Clinical Practices and DOT-IATA certifications through various accredited programs. For studies that utilize CRT services, the CRT requires all members of the research team to be certified in HIPAA, Human Subjects Protection, Good Clinical Practices and other study specific certifications. The CRT is available to assist with this process.
CRT nurse coordinators are available to provide technical support, perform study related procedures, and serve as a liaison between research investigators and study participants. Nursing staff work closely with each investigator to ensure all procedures are performed in accordance with hospital regulations, standards of nursing practice, good clinical practice and study protocol guidelines. Services include:
Routine and complex vital signs
Assistance with biopsies
Timed collection of blood specimens
Intravenous and oral glucose tolerance testing
Research Coordinator Assistance
CRT coordinators are available to assist investigators with the day-to-day conduct of research studies. Services include:
Conduct of study related visits and procedures (e.g., participant screening, participant education, scheduling, consenting, enrollment, questionnaires, and preparation and shipping of specimens)
Data collection and management (e.g., creation of source document templates, completion of case report forms)
Mentoring services (e.g., training investigative staff)
Assistance with protocol monitoring and auditing visits
Study closure (e.g., organization and submission of study closure documents)
Regulatory Assistance Regulatory managers are available to assist investigators with submissions and reports to sponsors and/or institutional oversight bodies. Services include:
Submission of protocols, modifications and amendments
Working with sponsors and study teams to complete required startup regulatory packets
Reporting of adverse events, continuing reviews and study closure
Maintenance of regulatory binders
Preparation and guidance throughout monitoring visits and audits
Participant Recruitment The CRT is available to assist investigators with developing an efficient and ethical study recruitment plan. Services include:
Facilitating the use of ResearchMatchand ARresearch (online web portals that connects participants with researchers) and a mobile text alert service that notifies participants of opportunities to participate in research
Creating and distributing recruitment materials (e.g., print advertisements and direct mail items)
Managing relationships with media outlets (e.g., newspapers and radio)
Specialized Research Space & Lab Processing Located on the 5th floor of the Jackson T. Stephens Spine & Neurosciences Institute on the UAMS Campus, the Translational Research Institute’s (TRI) Clinical Trials Innovation Unit occupies ~ 2,500 square feet of designated research space including:
Participant waiting area and research restrooms
Secure storage rooms for study files and participant folders
Secure medication room
Three outpatient procedure rooms
Space for investigators to conduct participant visits
Distance health telemedicine unit
A designated research teleconferencing video unit which enables two-way live video and audio interaction with 75 counties and 135 Arkansas communities, including hospitals, community health centers, libraries, mental health clinics and home agencies. The unit can be utilized for recruitment initiatives, connecting with subjects who are unable to travel to the UAMS central campus or to educate other areas of the state about research.
Specimen processing lab
-20°C and -80°C freezers (for storage of specimens up to 12 months)
General laboratory equipment for sample collection processing and shipment (e.g., centrifuges, balances, etc.)
Mobile Support TRI’s Clinical Trials Innovation Unit offers mobile support, including travel to the following locations:
UAMS Medical Center and any other location on the UAMS central campus