Using the Clinical Research Centers

To utilize the CRC, the study must be submitted for a feasibility review. Request support for a new study.

• Documents to upload to the submission form, if available at time of submission. (Otherwise, please email when ready.)
  • IRB, CTSI SRC, Radiation Safety, and Institutional Biosafety approvals
  • Current protocol version
  • Current informed consent(s)
  • Current pharmacy manual
  • Current lab manual
  • Current Manual of Operations
• If the study has not been peer-reviewed, it will be referred to the Indiana CTSI Scientific Review Board.
• After the feasibility review, either provisional approval or disapproval will be provided.
• Final approval will be provided when IRB approval, CTSI SRC approval (if applicable), Radiation Safety approval (if applicable), and IBC approval (if applicable) has been received AND the CRC start-up meeting (or orientation meeting for “room only” requests) has taken place.

• Once the study has been reviewed and provisional approval has been provided, the study team will be contacted to schedule an orientation meeting. The purpose of this meeting is to confirm the CRC support being requested and to review CRC required documents and processes.
• If the person who will be scheduling visits for the study has not previously submitted visit requests, a virtual scheduling orientation meeting will be arranged between the CRC scheduler and the study scheduler.
• If the study is requesting Room Only as a resource, only the orientation meeting needs to occur prior to starting the study.

• Physician orders created by the study team should be emailed for review. Templates for physician orders can be located below.
• Once orders are received and flowsheets created, the CRC start-up meeting will be scheduled.
• The CRC start-up meeting is NOT the Sponsor Site Initiation Visit. The purpose of the CRC start-up meeting is to finalize CRC source documents and discuss logistics for visits occurring at the CRC.

• Once the CRC start-up meeting has occurred (for studies requesting nursing support) or the CRC orientation meeting has occurred (for Room Only support), the visit request form will be used to request visit space and support.
• Visit requests will be made via this link.
• If the person who will be scheduling visits for the study has not previously submitted visit requests, a virtual scheduling orientation meeting will be arranged between the CRC scheduler and the study scheduler.
• Confirmation that the requested visit has been scheduled will be sent via email. If there is an issue with the request, the person who scheduled the visit will be contacted to discuss options.
• When the participant arrives for their scheduled visit, they will be shown to their assigned room. The study team will be contacted.
• Once the participant has signed consent, a copy of the signed consent will be provided to the CRC. At the top of page 1, include CRC study  number, participant name, and date of consent (it can be difficult to decipher name and date).

• Once the CRC start-up meeting has occurred, the lead research coordinator/nurse will be asked to provide an in-service to the CRC nursing staff.
• The in-service will occur within 1-2 weeks prior to the first participant visit at the CRC.
• A study summary will be provided at the in-service; this will be used as a self-training tool for staff not able to attend the in-service.