For help with clinical trial coordination, from contract negotiation and IRB protocol submission to the enrollment of subjects, the collection of data, and study close out—contact the clinical research facilitators at the IU Enterprise Clinical Research Operations (ECRO):
Tessa Oakes, RN, BSN, CCRC
Ronda McNamee, RN, BSN, CCRC
The management of both administrative and clinical aspects of pharmaceutical and device research trials is supported by IU Health Enterprise Clinical Research Operations (ECRO). ECRO is comprised of 12 registered nurses. It is the central trial coordination center for multiple IU Health Hospital facilities. All ECRO nurses have a BSN degree, are CCRC-certified through the Association of Clinical Research Professionals (ACRP), and are thoroughly educated in the federal regulations and Institutional Review Board (IRB) policies relevant to protocol management of clinical trials. ECRO nurses can also help identify physicians within the IU Health system who are interested in research. The nurses provide 24-hour, 7-day-a week coverage for trials at IU Health Methodist Hospital and also serve IU Health University, IU Health North, and IU Health Saxony Hospitals. Additionally, this group has the ability to manage multi-site clinical trials throughout the IU Health system under the approval of a single IRB.
Protocol Management Services available through ECRO at IU Health:
- Negotiate budget with study sponsor
- Assist with protocol and informed consent development
- Coordinate ancillary departments
- Educate caregivers on protocol requirements
- Submit device studies to CMS for pre-approval for billing
- Recruit, educate and follow up with patients
- Collect and document data
- Report adverse events to sponsor & IRB
- Maintain financial oversight; review billed services quarterly
- Provide 24-hour accountability for clinical trials
Please visit the ECRO website for additional information on the many trial coordination options available to you.