If you would like to apply to utilize any of the GCRC resources for your protocol, the following items are required for application to the GCRC:

Getting Started...

• Application materials are submitted to the GCRC via the eIRB system.
  • Copy of full protocol
    • Protocols that utilize the GCRC must include all of the following elements: background, clearly stated hypothesis and specific aims, research design and methods, statistical design and analysis plan, population description, references, and the consent form.
    • If investigator-initiated: grant application, including budget
    • If industry-initiated*: sponsor’s protocol, investigator’s brochure, and contract & budget
  • Complete GCRC Resource Request Form (
  • Print GCRC Data & Safety Monitoring Plan (DSMP Template ).  Complete and sign this form and attach it to the eIRB protocol submission.  Please also return a signed copy of the form to the GCRC via inter-office mail. 
• The application is reviewed by GCRC Advisory Committee for science and resources.
• The investigator will receive a letter from the GCRC regarding the results of the protocol review and confirmation of resources approved.
• Initiation of study on the GCRC is contingent upon IRB approval and watermarked consent forms.
• All key personnel and anyone obtaining informed consent must be in compliance with the Continuing Research Education Credit Program (CREC), which consists of a Core Certification as well as Continuing Certification in human subjects protection training.   

Keeping it Going...

• During the course of the study, approved amendments are sent to the GCRC, via the eIRB system, in advance of any changes to the orders or procedures involving subjects.
• If any portion of the sponsor's protocol is revised, furnish the GCRC Administrative Office with a new copy.
• Any internal serious unexpected adverse events must be reported to the GCRC within 24 hours, as well as to the IRB. Report all others according to IRB policy and summarize at the time of continuing review. 

In order to maintain the support and use of GCRC resources, IRB and GCRC approvals must be renewed prior to the IRB’s “approved through” date. Print the GCRC Continuing Review form (CR Form  ) and attach to the eIRB Continuing Review submission.

Don't Forget...

• It is a requirement that all publications resulting from this protocol must cite our CWRU NIH grant, GCRC M01 RR00080.
  • This is the principal measure of productivity for the Center and the acknowledgment that federal funds were used in the conduct of the project.
  • An appropriate citation is “This research was supported in whole or in part by a grant from the NIH, M01 RR00080, General Clinical Research Center.”
• Use of any of the GCRC resources requires that investigators contribute to all annual reports prepared for the NIH containing information about the progress achieved on a protocol, reporting of all research support (as in other NIH grants), and publications resulting from and/or with GCRC assistance.
• A final report of the results of the study is required.

For additional information and detailed instructions, please contact the following offices, by phone, or links given below:

MetroHealth Medical Center
Administrative Office:
(216) 778-3130
aross@metrohealth.org

University Hospitals of Cleveland
Administrative Office:
(216) 844-4902