Yale School of Medicine.    
General Clinical Research Centers  
Grants & Contracts. Human Investigation Committee. Yale-New Haven Hospital. National Center for Research Resources. National Institutes of Health.
 

 

How to Apply for Support

We have revised our approval process to make it more streamlined. If possible, it is best to submit your protocol to the GCRC before the HIC. However, protocols which already have HIC approval are welcome, too.

Your protocol will be reviewed twice. The first meeting is an internal review called the Pre-Review meeting including the Principal Investigator (PI), members of the GCRC staff, an HIC representative and primary reviewer. The goal is to better understand your protocol and resource needs. The Pediatric Protocol Review Committee (PPRC) serves as the pre-review committee for pediatric protocols. (Please see GCRC Protocol Pre-Review Committee web page.) The second meeting is the review of the final revised protocol by the GCRC General Advisory Committee (GAC). This Committee is chaired by Peter Herbert, M.D., and includes 15 faculty members from across the Medical School. GAC approval is required before GCRC resources can be utilized.

Below are listed the steps:

Step 1

Protocol Submission
E-mail, all documents as well as deliver a hard copy of all protocol documents to Sonja Beamon Rezendes, Administrative Director of the GCRC (Room 10-520 E. Pavilion), phone: 785-4424, Sonja.Beamon@yale.edu. Please include all HIC documents (i.e. consent(s)/parental permission forms/assents; HIPAA Research Authorization Form or waiver as appropriate) and completed GCRC application. If already HIC approved, the HIC approval letter is also necessary.

Step 2

Pre-Review Meeting
You will be contacted by Sonja Beamon Rezendes or Gina D'Agostino, MSN, (Research Nurse Coordinator) to schedule the Pre-Review meeting on the GCRC.

Step 3

GAC Review
After the protocol is finalized, it will be reviewed at one of the monthly GAC meetings. GAC and HIC approval are required before the GCRC resources can be utilized.

If you have any questions regarding the approval process, contact us at any of the following numbers:

Sonja Beamon Rezendes, Administrative Director, 785-4424
Gina D'Agostino, MSN, Research Nurse Coordinator, 688-6500
Thomas Carpenter, M.D., Research Subject Advocate, 785-6526

 

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