STEPS TO STUDY ACTIVATION

Request Support from Clinical Research Centers (CRCs)

The Indiana CTSI Clinical Research Centers (CRCs) provide high-quality, competitively priced clinical research services and facilities for Federal- and Industry-funded Indiana CTSI investigators, including clinic space, skilled nursing staff, on-site lab processing, equipment, and nutrition services for both inpatient or outpatient adult or pediatric visits.

Indiana CTSI CRC Locations

The Indiana CTSI has CRC locations on the IU Indianapolis and Purdue campuses.

- - IU Indianapolis CRC Facilities are located in Indiana University Health Hospital, Riley Hospital for Children, and the Goodman Hall Neuroscience Center. More information about the IU Indianapolis CRCs, including the current fee schedule, can be found here.
  - The Purdue Campus CRCs are located in Stone Hall and Lyles-Porter Hall.

Note: Although not yet designated as an Indiana CTSI core facility, the Nutrition and Exercise Research Center (NERC) is a clinical research center located on the IU Bloomington campus. It is currently available to researchers studying interventions related to diet and physical activity. Visit their website to request NERC services or contact the center’s co-directors.

Indiana CTSI CRC Submission and Approval Process

Before a research study can utilize CRC services and facilities, researchers must apply for and receive approval by the CRC.

Researchers should submit their protocol electronically after they receive IRB approval. Incomplete submissions may result in delay of review.
When all the required information is received, the CRC feasibility review will begin.
After the feasibility review has been completed, final CRC approval is communicated through email.
When a protocol amendment impacts the CRC, the changes need to be submitted for CRC review. The study team is responsible for communicating protocol changes that impact the CRC.

The table below identifies the documentation upload requirements for CRC protocol review based on the CRC level of involvement in the study.

CRC Involvement	Protocol	IRB-approved consent form	Documentation of IRB Approval	Laboratory Manual	Pharmacy Manual	Manual of Procedure	Radiation Safety Approval	IBC Approval & Application
				(if available)	(if available)	(if available)	(if applicable)	(if applicable)
Nursing	yes	yes	yes	yes	yes	yes	yes	yes
Nutrition Services	yes	yes	yes	no	no	no	no	no
Blood Draw & Processing (blood drawn on the CRC)	yes	yes	yes	yes	no	no	no	no
Vital signs only	yes	yes	yes	no	no	no	no	no
CRC Use (no services)	yes	yes	yes	no	no	no	no	no

IU Simon Comprehensive Cancer Center (IUSCCC) Additional Information

For Cancer Center Trials (studies involving cancer patients):

If a study requires ICRC resources, the request to CRC outlined above must be submitted prior to Cancer Center SRC review.

Contacts & Resources

Requesting support from the Clinical Research Centers is only one component of study activation. Additional requirements should be reviewed using the Clinical Research Roadmap.