Institutional Approval for Clinical Research
Clinical research at Duke is a collaboration among study teams and various central offices. To find out more information about the institutional approval process, please click the link below.
Clinical Research Support Pages
REDCap (Research Electronic Data Capture) is a secure, web-based application designed to support data capture. REDCap was developed by Vanderbilt’s CTSA and is currently used and supported by thousands of consortium partners across the globe. REDCap at Duke is managed and supported by the Duke Office of Clinical Research (DOCR) Research Management Team, located in the School of Medicine. RMT provides research and data management support to investigators across Duke.
OnCore is the Clinical Research Management System (CRMS) developed by Forte Research Systems that will support clinical research activities at Duke which will allow for enhanced clinical research study management, robust reporting, enrollment tracking, and accurate clinical research billing.
Maestro Care (Epic) is the unified electronic medical record and clinical care application for Duke Health. Epic go-live deployment for all of Duke Health was completed on March 1, 2014 and is the primary health record application at Duke University Hospital, Duke Children’s Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care Physicians Network, and all affiliates of Duke Health.
The Collaborative Institutional Training Initiative (CITI) Program is a leading provider of research ethics, compliance, and professional development education. Many organizations and more than 1 million learners around the world use CITIs online courses annually. Duke has subscribed to the CITI Program for its human subjects research training requirements, as well as many other research-training topics. Learn more about the CITI Program at their website.
The iRIS system, created by iMedRIS, is the electronic submission system utilized by the Duke research community to submit human participant research protocols online, using a web browser. Protocols submitted in iRIS are routed, reviewed, and finalized electronically.
With the secure Adobe Sign cloud-based app, you replace paper and ink signature processes with fully automated electronic signature workflows. Use a modern browser to prepare, send, sign, track, and manage signature processes. No software is needed for signers (who can be internal or external to Duke, provided no PHI is being sent).
CRUs and OOs
Clinical Research Units (CRUs) and Oversight Organizations (OOs) are the operating business units responsible for the integrity, financial accountability, regulatory compliance, quality, and academic productivity of clinical research studies taking place at Duke Health.
Study selection decisions are made within the CRUs and OOs, as well as the coordination and allocation of resources, and the flow of funds associated with individual studies.
Each CRU/OO consists of leadership comprised of one or more of the following:
- Faculty Advisory Board
- Director
- Financial Practice Manager
- Research Practice Manager
To find out more about CRUs and OOs across Duke, please click the link below.