Welcome Investigators and Study Coordinators!
Welcome to the Office of Clinical Research (OCR) and the premier resource for clinical trial information at Indiana University, its strategic partner, IU Health, and its research collaborators.
The OCR reviews and negotiates contracts to
- Protect IU’s and the investigator’s rights for all industry sponsored clinical trials, and
- Ensure provisions are consistent with applicable laws, regulations, policies, procedures, and guidelines (i.e., publication, intellectual property, indemnification)
Please visit Additional Resources to access further guidance, links, and helpful documents (e.g., templates, training materials, policies, FAQs, OnCore, etc.) or contact the OCR directly.
Let the OCR help you achieve your goals!
Attn: Office of Clinical Research
410 W. 10th Street, Suite 1020
Indianapolis, IN 46202
Phone: (317) 278-2546
Centralized STudy Activation Resource
The Centralized STudy Activation Resource (CSTAR) is a data and document collection tool used by the Office of Clinical Research to initiate study activities. The collected information helps to determine coverage analysis needs along with requirements for entry into Indiana University’s centralized clinical research management system, OnCore. CSTAR also collects basic administrative study data for creating a project record in OnCore, allowing for easy management of protocol and subject data throughout the life of your project. Recorded information should be accurate and complete to ensure compliance with university policies and federal regulations and to provide Indiana University and IU Health leadership with the most accurate representation of clinical research available.
The Indiana CTSI Clinical Research Center at IUPUI conducts both adult and pediatric protocols and supports PHS funded protocols (A studies) and Industry funded studies (D studies). There are three CRCs located on the IUPUI campus. The first and only CRC with an inpatient unit is located at IU Health University Hospital. The second CRC is located at Goodman Hall Neuroscience Center of Excellence. The third CRC is the Children’s CRC located at IU Health Riley Hospital for Children. The CRCs on the IUPUI campus provides space and staff support [nurses and/or medical assistants] to conduct academic and industry sponsored clinical research studies for both inpatient and outpatient visits.
The Indiana CTSI Clinical Research Center at Purdue University conducts both adult and pediatric protocols. This CRC also provides staff support (nutrition and medical assistant).
The CRC Administrative Manager is available to provide investigators with information related to the services offered and the facilities available in the CRC, instructions for protocol submission, facilitation of the protocol review process, and for general assistance related to CRC information/processes.
For more information, please visit the CRC website or contact Laurie Trevino, Operations Manager or Sharon Cromer, Administrative Manager.
IU Health Enterprise Clinical Research Operations (ECRO) is the central trial coordination center for multiple IU Health facilities. It supports the management of both administrative and clinical aspects of pharmaceutical and device research trials. 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 ECRO:
Tessa Oakes, RN, BSN, CCRC
Ronda McNamee, RN, BSN, CCRC
Please visit the ECRO website for additional information on the many trial coordination options available to you.
Standard Pricing Schedule for Industry Sponsored Clinical Trial Studies
A schedule of recommended fees for industry sponsored clinical trials is available to Indiana University School of Medicine and IU Health investigators and study coordinators.
The fee schedule serves as a guidance to assist in the development of budgets for industry sponsored clinical trials by:
- Providing a consistent starting point for budget negotiations with industry sponsors.
- Ensuring clinical trial teams more accurately estimate time/resources required for clinical trial activities.
- Offering a fee schedule to develop a budget based on study complexity.
- Promoting transparency of research related costs for industry sponsors.
- Facilitating budget preparation as the current version of standard fees will be available in the OnCore® CTMS Chargemaster or from the OCR.
For more information – please contact the Office of Clinical Research at firstname.lastname@example.org or 317-278-2546