IU Clinical Trials Office (IU-CTO)

Negotiates, reviews, approves, and executes contracts (human subject clinical trials) supported by private industries and other for-profit entities
For more information, please contact the IU-CTO

Legally binding agreement between at least two parties that outlines the terms and conditions of a specific study which is supported by a specific entity and conducted by a specific investigator
For more information, please contact the IU-CTO

Contacts IU/ Provides CDA

The researcher’s department must provide the CDA to the IU-CTO to begin the negotiation of the contract. CDAs must be emailed to the IU-CTO general mailbox at cto@iu.edu
For more information, please contact the IU-CTO

Study Feasibility

Generally, an industrysponsor will provide a feasibility questionnaire to the researcher/ study coordinator following the execution of the CDA to determine the likelihood of a study being successfully conducted. Factors that are considered include: departmental resources, study team experience in research, patient population for timely the accrual numbers, etc.
*Each study varies. Please contact the specific department for details.

The Indiana University Institutional Review Boards (IRB) are responsible for the review and approval of all human subject research conducted at Indiana Universityand affiliated institutions, as well as, administers the human research protection program at Indiana University.
Western Institutional Review Board (WIRB) can be utilized in certain circumstances. Please contact the Human Subjects Office for additional information

Internal Approval Process

KualiCoeus Grants: Indiana University’s web-based approval process required for all clinical trials. The approval process must be initiated by the investigator’s department.
*Please contact the specific department for updates.

Tracking Process

Identify and monitor enterprise-wide metrics describing the level of ongoing industry sponsored clinical trial activities

Prior to study account set-up, three items are needed: a fully executed contract, IRB approval, and an updated internal budget from the department. The IU-CTO will follow-up with the investigator’s department for any missing items once the CTA is fully executed. Once received, all items are provided to the Office of Research Administration for account set-up.

Pre-Study Start Up Activities

A process in which study teams initiate/complete study-related activities: FDA 1572 form, financial disclosure form, investigator brochure, IRB documents, etc.
*Each study varies. Please contact the specific industry sponsor for details.