The Indiana Clinical and Translational Science Institute (ICTSI) is a reality. The transition from a GCRC to the ICRC - Indiana Clinical Research Center - brings some welcome changes for you.

The submission process:

• A (G)CRC NIH-formatted protocol is no longer necessary. You need to provide all IRB documents (the parent protocol, SSS, IC, etc.), an ICRC resources requested form (on the web site), and a protocol flow sheet.
• Ancillaries (safety biochemistries, biochemistry Core Lab, Pharmacogenetic lab, DNA preparation, Radiology, Pharmacy, etc.) will no longer be provided by the ICRC for new applications.
• There will be no deadlines for submission.
• A web-based submission process (E-PAR) is being developed that will allow you to load your submission documents and enter submission data via a web link.
• In the meantime, submission documents should be submitted to Sharon Cromer via e-mail ( This e-mail address is being protected from spambots. You need JavaScript enabled to view it ), as you have done in the past.

The review process:

• An ICRC Advisory Committee will convene in October.
• Currently, funded studies (NIH, Drug Sponsored) receive an Administrative, expedited review/approval.
• The review/approval process for non-funded studies is still being formulated.
• A letter indicating the status of your study will continue to be provided by ICRC staff.

These changes will provide a more streamlined submission and review process.