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The GCRC has been replaced by the new CTSI. As the CTSI gets established some of the procedures below may no longer be valid. The IRB is working with the CTSI to integrate our review procedures to make the process as streamlined and efficient as possible.

The CTSI is an NIH funded center charged with advancing medical knowledge in a clinical setting. The CTSI provides a variety of resources to researchers who choose to conduct their research in the center.

Researchers who wish to conduct their studies with the CTSI must submit their project separately to both (1) the IRB and (2) the CTSI. When doing so you must submit the same exact IRB paperwork to both committees. If one committee requests any changes you must make the same exact changes to the paperwork submitted to the other committee.

After the initial protocol approval the investigator is responsible for sending a copy of all future IRB approved submissions (revisions, adverse events, continuing review, etc) to the CTSI.

Please note:

  1. BEST PRACTICE: Work with the CTSI to coordinate the review of your project through the CTSI and IRB.
  2. A knowledgeable representative from your study must attend the IRB meeting to assist the Board with their review of the project.
  3. You may choose to submit via a "harmonization process" and wait until after the IRB meeting and reply to all requests at one time. This is simpler for the investigator, but will definitely mean it will take a little longer for your project to be reviewed.
  4. If you are unable to make all of the changes requested at the intermediate steps in the process you may choose to wait until after the IRB conducts it's review. Pro = only correct and copy paperwork one time. Con = will result in longer amount of time to have project approved.
  5. You are not required to submit to one office before another - you may submit your project to either committee at any time. However you must remember that (1) you cannot start your project anywhere until you have IRB approval, and (2) you may not start your project in a CTSI CRU until you have approval from both offices/committees.

Prior to submitting any paperwork to the CTSI or IRB you should visit their web site at





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Updated: 02/16/2010 10:35 AM

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