The Clinical Trials Innovation Unit offers a variety of facilitation, consultation and support services. Investigators are encouraged to contact the CTIU at TRICoordinators@uams.edu regarding these services.
Connecting sponsors and investigators
Clinical trials are often initiated when a sponsor inquires if there are any researchers who might be interested in becoming a principal investigator on their clinical trial. The CTIU helps sponsors connect with appropriate investigators. Investigators interested in finding and conducting a clinical trial are encouraged to contact the Stakeholder Engagement Coordinator at PKChristie@uams.edu 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 Research Contracts 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 feasibility questions from the sponsor, obtaining the CDA from the sponsor, and submitting it for approval.
Preparation for & assistance during pre-site selection visit and site-initiation visit
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-site selection visit may be required by the sponsor. A sponsor may use a pre-site selection 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.
CTIU’s Clinical Research Team offers support to help investigators prepare for these visits and will assist throughout each visit.
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 (AR-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 (AR-CRIS) is a comprehensive set of open source software tools for electronic management of clinical trials and associated data. All components of the UAMS AR-CRIS are web based, enabling sharing and integration of clinical research information for single and multi-site trials. AR-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 AR-CRIS tools, please contact TRI using the brief Request Services form.