CTSC Clinical Research Unit
MetroHealth Medical Center
2500 MetroHealth Drive
2nd Floor Hamann
Cleveland, Ohio 44109 [
CTSC Clinical Research Unit at MetroHealth
If you would like to apply to utilize any of the GCRC
resources for your protocol, the following items are required for application to
- 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
- 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
- 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
- If any portion of the
sponsor's protocol is revised, furnish the GCRC Administrative Office with a
- 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
attach to the eIRB Continuing Review
It is a requirement that all
publications resulting from this protocol must cite our CWRU NIH grant, GCRC
- 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
MetroHealth Medical Center
University Hospitals of Cleveland