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Protocol Review and Monitoring Procedures

 

Protocol Submission Instructions and Forms

 

The Protocol Review and Monitoring INITIAL SUBMISSION Form is for new protocols. Please carefully read all instructions, prior to an Initial Submission.

  • PI initiated protocols and industry sponsored protocols: Submit three (3) copies of all Protocol Review and Monitoring forms, three (3) copies of the protocol, and three (3) copies of the PI NIH biosketch.
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    Clinical trial protocols and protocols peer reviewed and supported by NIH mechanisms: Submit two (2) copies of all Protocol Review and Monitoring forms, two (2) copies of the protocol, and two (2) copies of the PI NIH biosketch. 
     
    These protocols can be simultaneously reviewed by the IRB and the Protocol Review and Monitoring. 
     
    Please submit the protocol first to Protocol Review and Monitoring for signature, then to IRB.

 

The Protocol Review and Monitoring CONTINUING SUBMISSION Form for annual review.  Please carefully read all instructions, prior to a Continuing Submission.

 

  Submit two (2) copies of all Protocol Review and Monitoring forms, two (2) copies of the protocol, and two (2) copies of the PI NIH biosketch.

 

The Protocol Review and Monitoring AMENDMENT FORM. Please carefully read all instructions, prior to an Amendment Submission.

 

  • Submit two (2) copies of all Protocol Review and Monitoring forms, two (2) copies of the protocol, and two (2) copies of the PI NIH Biosketch
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Submission Location:

Copies of the Protocol Review and Monitoring form, the protocol, and PI NIH Biosketch should be submitted to:

Cancer Center

Medical Center Administration Building (MCA),Room 318

914 S. Wood Street

 

Submissions are accepted from 8:30 am - 12:00 pm, and  from 1:00 pm - 5:00 pm.   Pending availability, special arrangements can be made with the staff contact, to drop off protocols between 12:00 pm and 1:00 pm.

 

MCA is in the courtyard behind the Neuropsychiatric Institute (NPI, 912 S. Wood Street), directly East of the College of Medicine Research Building (CMRB).

 

Protocol Review and Monitoring Outcomes and Notification

 

Protocol Review and Monitoring will result in one of the following outcomes:

 

· Approval: The protocol is approved for opening to accrual contingent upon obtaining IRB approval.

· Modifications Required: Before approval from Protocol Review and Monitoring, the PI needs to address minor issues.

· Deferred Due to Overlap: The PI will be asked to provide a rationale for approving competing protocols.

· Deferred Due to Scientific Reason: There are sufficient problems with the protocol and substantial revisions and formal reconsideration by Protocol Review and Monitoring are required.

· Disapproval: The protocol is not approved for opening to accrual at U of I.

 

The PI and contact person are notified no later than two days after the meeting date.  The formal letter is emailed in a PDF file.  The average turn around time for a protocol to receive approval is two and a half weeks after the deadline date provided no modifications are required.

 

Meeting Schedule

Here is the Protocol Review and Monitoring meeting schedule.  Protocol Review and Monitoring meets twice a month.  Protocols received by Protocol Review and Monitoring and reviewed on or before the deadline date are scheduled for review two weeks later. 

 

New investigators are encouraged to review the Cancer Center's Protocol Review and Monitoring Policies and Procedures before submitting a protocol.

  

If you have any questions or need additional information, please contact Meha Singh, MS at 312-355-3046 or mehasing@uic.edu