Contracts

The OCR reviews and negotiates contracts for IU and its investigators for all industry sponsored clinical trials. The OCR also provides the necessary information and tools that you need to successfully collaborate with Indiana University, its strategic partner IU Health, and its other research collaborators. Please visit our Resources page to access further guidance, links, and helpful documents (e.g., templates, training materials, policies, FAQs, OnCore, etc.) or contact the OCR directly.

Indiana University
Attn: Office of Clinical Research
410 W. 10th Street, Suite 1020
Indianapolis, IN 46202
Email: ocr@iu.edu
Phone: (317)278-2546

 

Clinical Trial Coordination

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 Assistant Directors of Clinical Finance and Resource Management at IU Health Enterprise Clinical Research Operations (ECRO):

Tessa Oakes, RN, BSN, CCRC

TOakes@iuhealth.org
(317) 962-5396

Ronda McNamee, RN, BSN, CCRC

rmcnamee@iuhealth.org
(317) 962-0816

The management of both administrative and clinical aspects of pharmaceutical and device research trials is supported by IU Health Enterprise Clinical Research Operations. ECRO is comprised of 12 registered nurses and 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, IU Health Saxony, and other regional 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 and legal contracts 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
  • Communicate with investigators, sponsors, IRB, and patients
  • Maintain financial oversight; review billed services quarterly
  • Provide 24-hour accountability for clinical trials

Please visit the ECRO website for additional information on trial coordination available through IU Health Enterprise Clinical Research Operations.