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STEPS TO STUDY ACTIVATION

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Evaluate Study for Statewide Program

IU Health operates a network of clinical research-ready hospitals and facilities across the state, known as the Statewide Clinical Research Program. This program includes IU Health Bloomington Hospital, IU Health Ball Memorial Hospital, IU Health Arnett Hospital, IU Health Fort Wayne Neurological Center, and the Academic Health Center in Indianapolis, with plans to expand to additional sites throughout Indiana

Benefits of the Statewide Program

The Statewide Program provides numerous advantages to researchers, including the following abilities:

  • Establish an entry point, ensuring researchers have clear access to resources
  • Expand patient pools and demographics for a more robust sample
  • Benefit from collective bargaining
  • Gain new insight through collaboration
  • Provide availability of clinical research to more IU Health patients

Services Provided by the Statewide Research Network:

  • Standardizing research education and training
  • Centralizing and coordinating key administrative functions
      • Three-party CDA / CTA process
      • Collaborative Budget Negotiation
      • Centralized Regulatory Support
  • Principal Investigator Oversite Plans
  • Monitoring and auditing statewide
  • Assisting with policy alignment and implementation
  • Facilitating research communications
  • Sharing sponsored research opportunities throughout IU and IU Health
  • Developing research infrastructure to strengthen efficiency
  • Monthly phone calls with research teams throughout the state

Statewide Program Overview

The IU Health Statewide Workflow document is a helpful resource that outlines the two primary scenarios for statewide studies as shown below.

SCENARIO 1: PI at Each Individual Site

A sponsor or manufacturer approaches IU Health seeking to investigate a product at several locations throughout the system.

  • The Sponsor requests drug accountability and randomization at each location
  • Budget and Contract negotiations done together for all sites
  • One reliance request for all sites
  • Each site completes IRB submission and OnCore registrations 
SCENARIO 2: One PI for all Sites
  • Each site completes OnCore registration 
  • Regulatory is done by the Statewide Regulatory Compliance Leader
  • At least one touch base via TEAMs per month with all investigators to discuss progress of the study
  • PI Oversight Plan includes:
      • Oversight by PI with at least one touch base per month
      • Safety and Communicaton Plan
  • Quality Management includes:
      • Quality audits (both regulatory and patient audits)
      • Audits for first subject enrollment at each site
      • Other audits as necessary as the study progresses

IU Simon Comprehensive Cancer Center (IUSCCC) Additional Information

For Cancer Center Trials (studies involving cancer patients):

  • If the protocol is a cooperative group or industry study that involves cancer research or patients, please utilize the process as outlined above. 
  • If the protocol is an investigator-initiated study that involves cancer research, Cancer Center resources, or patients receiving care through the Cancer Center, it must move through the CTO’s Multi-center Team, who will help provide oversight and coordinate with the Statewide Program team.
  • Please contact the Cancer Center’s Multi-center team leader: Amber Bauchle adbauchl@iu.edu  (317) 274-2869; see also the MCC resource flyer

Contacts and Resources

If you have questions as you are considering the Statewide Clinical Research program, or before beginning enrollment in a statewide study, please refer to the contacts below:

Evaluating your study for the Statewide Program is only one component of study activation. Additional requirements should be reviewed using Clinical Research Roadmap.