PURPOSE:
Provide the PI assistance with protocol submission process.  You may receive assistance with all aspects of the submission process, from protocol builder, writing the protocol and consent, pre-review of IRB documents, review and assistance with the statistical plan, and assistance with the GCRC application.

GCRC PROTOCOL DEVELOPMENT TEAM
Helena Estes-Johnson RN - IRB Coordinator
Lynne Simpson RN - GCRC Protocol Manager
Jim Patrie MA - Biostatistician
David Boyd MS - Biostatistician
Pam Sprouse - Administrative Director

STEPS FOR THE PI (or designee):
1.  After you submit your application to the GCRC, we will send it to Jim Patrie and David Boyd, the biostatisticians, to receive their approval prior to review by the GCRC Advisory Committee. The IRB documents will also be pre-reviewed.

2.  Once Jim, David, and the IRB have completed their reviews, Helena will send the documents back to you with the suggested adjustments and corrections.

3.  When you return the corrected documents, Lynne will combine the cover-sheet, IRB protocol and GCRC application into one review document for the GCRC reviewers, along with other forms and questionnaires.

4.  The co-chair of the Advisory Committee will assign a reviewer who will contact you with comments and questions prior to the scheduled meeting.

5.  Travis Key will send you an email asking you to attend the GCRC Advisory Committee meeting on either the first or third Tuesday of the month. 

6.  After the meeting, Pam Sprouse will send you a letter describing the committee's decision and requested corrections.

7.  Lynne will email you the review document. Please make the requested changes (using the "Track Changes" feature) and return it to Lynne.

8.  Your reviewer will check the corrected documents and either give approval or request clarification or more information. 

9.  Lynne will notify Helena when your protocol has been approved by the GCRC and is ready for IRB submission.

10.  Helena will make all necessary copies, obtain additional documents for the IRB submission (Investigator's Agreement, protocol information sheet), and submit the protocol to the IRB.

11.  Following the IRB meeting, Helena will pick up the IRB letter and send it to you.  Any minor changes or clerical errors can be done by Helena and the remaining by you or your study coordinator. 

12.  After the IRB requested changes have been completed, Helena will submit the documents back to the IRB.

13.  Once the IRB has approved the protocol, Helena will pick up the approval and stamped consent and send them to you.

14.  You or your study coordinator should contact Lynne to develop and sign the flow sheets and doctor's orders and receive information on scheduling subjects. 

15.  Your protocol is fully approved and you are ready to GO!