Welcome Investigators and Study Coordinators!
The OCR reviews and negotiates contracts to 1) protect the rights of IU and its investigators for all industry-sponsored clinical trials, and 2) 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.
CDA Request Portal
To protect confidential information exchanged between Indiana University and third parties, the execution of a Confidential Disclosure Agreement (CDA) is required.
To request the negotiation and signature of a Confidential Disclosure Agreement (CDA) for a clinical trial, please click this Request CDA button and complete the form.
You will be notified when your request is complete.
Centralized Study Initiation: “Big Red Button”
The IU Office of Clinical Research now has a tool to collect the needed information and documents for entering a new protocol into OnCore (IU’s centralized clinical research management system) and initiating the Coverage Analysis Review process. This form should be initiated as soon as a final protocol is available and can happen simultaneously with IRB submission and contract negotiation with the processes informing each other. Centralized Coverage Analysis is mandated across the institute to ensure compliance with federal regulations and goes hand-in-hand with OnCore new protocol entry; therefore, entering accurate information is critical to ensuring that a study complies with university policies and federal requirements. IU is cultivating OnCore as a “source of truth” for information about clinical research occurring at IU and IU Health. The Coverage Analysis Team (CAT) uses information collected in this form to develop the OnCore protocol entry, communicate with the study team throughout the Coverage Analysis Review, and identify ancillary services involved in the study.
What Does the Clinical Research Study Intake Form Do?
- Initiates process for new study entry into OnCore
- Initiates coverage analysis review
**Please note: This form does not initiate an IRB submission.
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). Three CRCs are located on the IUPUI campus. The 1st and only CRC with an inpatient unit is located at IU Health University Hospital. The 2nd CRC is located at Goodman Hall Neuroscience Center of Excellence. The 3rd CRC is the Children’s CRC located at IU Health Riley Hospital for Children. The CRCs on the IUPUI campus provide 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 provides 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