Facilitation, Consultation and Support – CTIU

The Translational Research Institute (TRI) Clinical Trials Innovation Unit (CTIU) offers a variety of facilitation, consultation and support services. Investigators are encouraged to contact the CTIU regarding these services.

Connecting sponsors and investigators

Clinical trials are often initiated when a sponsor inquires if there are any researchers that might be interested in becoming a principal investigator on their clinical trial. The CTIU helps sponsors connect with the appropriate investigators. UAMS investigators interested in finding and conducting a clinical trial are encouraged to contact the CTIU program coordinator with information regarding their areas of interest.

Approval process of Confidential Disclosure Agreement (CDA)

Once a sponsor is connected with an investigator, the sponsor will send a confidential disclosure agreement (CDA) to the investigator. The CDA must be approved by the UAMS Contracts/Legal Review Unit and signed by the principal investigator. Usually the CDA must be signed before a sponsor will provide its proprietary information, such as the study protocol, to an investigator. The CTIU helps facilitate this process by helping the principal investigator answer any questions from the sponsor, obtaining the CDA from the sponsor, and submitting it for UAMS approval.

Preparation for & assistance during pre-study visits and site-initiation visits

After the CDA is signed, the investigator is encouraged to use the Feasibility and Study Planning Guide to decide whether the study is feasible. If so, a pre-study qualification visit and/or site-initiation visit may be required by the sponsor. A sponsor may use a pre-study qualification visit to determine if a) the site is adequate, b) the investigator and research team are motivated, experienced, and capable of conducting the clinical trial, and c) if access to the patient population is adequate.

Most sponsors will require a Site Initiation Visit (SIV). The purpose of this visit is to prepare a research site and get them ready to conduct the study. This occurs prior to participant recruitment.  The principal investigator must attend this visit and it is strongly recommended that all of the research team also attend. During this visit the research team will receive training on the study protocol design. Responsibilities regarding study procedures, regulations and documentation of study activities are discussed to ensure agreement and understanding. The sponsor’s representative may answer any of the study team’s questions at this time.

CTIU’s Clinical Research Team offers support to help investigators prepare for these visits and will assist them throughout each visit.

Coverage Analysis, Budget Development and Negotiation Services

The CTIU provides expert personnel to ensure that coverage analysis, budget development and negotiations are conducted in an efficient and fiscally compliant manner. The CTIU facilitates the start-up of clinical trials that utilize clinical services and/or include billing to third parties or participants, and educates investigators and their study staff on the financial aspects of conducting these kinds of clinical research projects. For more information please visit the TRI’s Research Finance Team page.

Study Management Tools

TRI Biomedical Informatics staff can assist investigators with identifying the appropriate study management tools, like certain modules from the Comprehensive Research Informatics Suite (CRIS), such as LimeSurvey. Training of research staff on these data tools is also available. TRI research coordinators are already trained in these tools and may use them when supporting an investigator’s research study.

Comprehensive Research Informatics Suite (CRIS) is a comprehensive set of open source software tools for electronic management of clinical trials and associated data. All components of the UAMS CRIS are web based, enabling sharing and integration of clinical research information for single and multi-site trials. CRIS includes applications for subject registration, study calendar management, free text extraction, participant recruitment, tracking regulatory events, reporting, and electronic data capture. If you need assistance with any of the CRIS tools, please contact TRI using the brief Request Services form.

Clinical Trial Conduct and Closeout

The CTIU links investigators with CTIU nurse coordinators and regulatory specialists to assist investigators with study initiation, conduct, closeout and regulatory activities as requested.  For more information please visit TRI’s Clinical Research Team page.