Clinical Research Administration
The Research Institute’s Clinical Research Administration (CRA) team primary goal is to work collaboratively with investigators and study teams. The CRA staff is comprised of both project managers and contract associates who together orchestrate regulatory, budgetary and contractual elements for clinical trials at the University of Kansas Medical Center and the University of Kansas School of Medicine-Office Research-Wichita.
The CRA acts as the central liaison between funding agencies, institutional review boards, and researchers at the University of Kansas Medical Center. Our mission is to assist researchers in navigating regulatory environment and to safeguard researchers from common risks experienced while conducting clinical trials.
Our team performs a wide range of services through every stage of clinical trial activity. Our team also serves as the coordinating center for several multi-site investigator-initiated studies where KUMC is the primary site and the KUMC-IRB serves as lead IRB for all sites in the study.
What Can You Expect from the Clinical Research Administration (CRA)?
Clinical Administration Team is proud to provide the following services to all investigators at KUMC. CRA provides services that include the following:
Regulatory Support--The regulatory team which is made up Project Managers (PM) and Project Assistants (PA). Once a study is Triaged, a PM and PA will be assigned for the entirety of the study for both Industry or Investigator sponsored Studies.
Pre-IRB Submission Support
- Provide services for investigator-initiated trials
- Prepare and submit initial Investigational New Drug (IND) and/or Investigational Device Exemption (IDE) documents
- Attend Study Kick-off Meeting
- Answer institutional questions about study processing
- Assist in the development of the participant consent form(s) ICFs
- Manage and set up Greenphire (ClinCard) account for subject payments
- Manage IRB processes for both KUMC IRB and reliance IRBs
- Secure IRB approval of protocol and consent forms and other required participant-facing materials
- Act as primary liaison between investigator and sponsor for completion of documents for final IRB approval
Ongoing Study Management
- Manage all subsites for multi-site investigator-initiated trials
- Prepare amendments and annual progress reports for IND and IDE submissions
- Process study closure for trial termination
- Manage IRB Process
- Secure IRB approval of protocol revisions and revised consent forms
- Obtain IRB approval for print or media advertising
- Assist with processing internal adverse events and IND safety reports for HSC submissions and approval
- Submit reports to HSC for annual re-certification of trials
Contracts and Budgets - A Clinical Trial Contract Associate will also be assigned to the study if it involves funding on a per patient basis. Contracts with other forms of funding are handled through Sponsored Programs Administration (SPA).
- The CTCA will:
- Attend the Study Kick-off Meeting
- Assist in the development of the participant consent forms(s) ICFs
- Prepare and negotiate trials budgets and contracts for new studies and amendments
- Clincaltrials.gov Registration and Results Reporting (hyperlink to clinicaltrials.gov)
- CRIS/Velos Study Entry and Support
- Clinical Trials Dashboard-Investigators quickview of study data extracted from CRIS/Velos