Clinical Research and Data Management
Data coordination and management for clinical trials conducted at the Winthrop P. Rockefeller Cancer Institute is provided by the 12-person Cancer Institute Clinical Research Data Management (CRDM) office.
The primary mission of the CRDM office is to provide all Cancer Institute clinicians with easy access to complete copies of active clinical protocols, assist with selecting protocols for patients, check patient eligibility for trials, collect protocol-required data and submit that data to the appropriate sponsor. The CRDM office also ensures that all clinical trials are conducted according to the UAMS institutional review board and Food and Drug Administration Good Clinical Practice guidelines.
The CRDM office uses an electronic system to distribute and maintain clinical research protocol; provide eligibility information; and monitor data quality, protocol compliance and accrual. Up-to-date protocol information is available to all Cancer Institute members with authorized access 24 hours per day, seven days per week.
Services provided include all of the following:
- IRB protocol submission
- Protocol Review and Monitoring Committee Submission
- VAMC Research and Development Committee Submission
- Filing Investigational New Drug (IND) applications with the FDA
- Writing informed consent documents
- Assistance with clinical trials contracts and budget preparation
- New patient eligibility screening
- Ongoing monitoring of protocol compliance
- Data collection and submission according to sponsor requirements
- Up-to-date protocol accrual monitoring
- Assistance with protocol development (informed consent writing, master drug file information, toxicity, etc.)
The Clinical Research Data Management office is a resource available to all Cancer Institute investigators. We look forward to talking with you about clinical trials at the Cancer Institute.
For additional information, call (501) 686-8274, or write to us at:
Clinical Research Data Management
University of Arkansas for Medical Sciences
4301 West Markham #724
Little Rock, AR 72205