THE GCRC APPLICATION PROCESS

The GCRC would like to make the application process as simple as possible. Therefore, your IRB Application will serve as your GCRC application; we also need a copy of all your submitted IRB documents (consent/assent, narrative/summary, etc). If you are conducting a multi-center or industry initiated study we require a copy of the master protocol. Your protocol may be reviewed simultaneously by the GCRC Advisory Committee (GAC) and the Institutional Review Board (IRB). The GCRC review has two purposes that are distinctly different from the IRB’s review:

Scientific review of the proposed research,
Review for allocation of available resources.

You can download the IRB application by going to http://www.rgs.uci.edu/rig/formshum.htm#new.

HOW TO REQUEST SPECIFIC GCRC SERVICES

In addition to submitting your IRB application, the GCRC/ICTS requests investigators to complete online application applicable for requests of GCRC/ICTS specific services. Each section in the online application describes the specific services offered by the Core Unit.

NOTE:

All research personnel are responsible for completing the UCI Research and Graduate Studies Human Subjects Tutorial and the HIPAA Tutorial (when applicable). This must be completed by all research personnel prior to the study's activation (first patient's first visit).

To fulfill this NIH and institutional requirement, go to http://tutorials.rgs.uci.edu/ and register using your UCInetID prior to completing the tutorial(s). Once you have completed the tutorial, the program will automatically e-mail you confirmation at your UCI e-mail address.

Final Document Checklist

A copy of the IRB application (minus the instruction pages and the disclosure pages), protocol narrative and consent forms.
A copy of data collection instruments that are not available in the public domain.
If the study is funded, one copy of all applicable protocol budgets and budget justifications.
If applicable: submit one copy of the master protocol (in the case of a multi-center or industry sponsored study).

Electronic version of each of the above referenced document must be uploaded in the online application.

I am ready to Apply.

GCRC Staff

The GCRC staff can provide valuable assistance in preparing a proposal. We strongly recommend that you contact the following individuals for information and advice regarding preparation of your proposal and study feasibility:

Dan M Cooper, MD.	Program Director	(714) 456-2317	dcooper@uci.edu
Ruth Bundy, PhD	Administrative Director	(714) 456-2313	rvbundy@uci.edu
Andria Pontello, M.S.	Bionutrition Research Unit Manager	(714) 456-2309	apontell@uci.edu
Pietro Galassetti, MD, PhD	Director, Bionutrition & Metabolic Core	(714) 456-5357	pgalasse@uci.edu
Robert Newcomb, Ph.D.	Director, Biostatistics	(949) 824-5366	rnewcomb@uci.edu
Vince J. Caiozzo, Ph.D.	Director, Applied Physiology and Human Performance Laboratory	(949) 824-5571	vjcaiozz@uci.edu
Steve Cramer, MD.	Director, Neuroimaging Core	(714) 456-6876	scramer@uci.edu
Paul Mills, Ph.D.	Director, UCSD GCRC Core Laboratory	(619) 543-2506	pmills@ucsd.edu
Frank Zaldivar, Ph.D.	Metabolic Core Lab Manager	(714) 456-6914	fzaldiva@uci.edu
Barbara Bodenhoefer R.N.	Nurse Manager	(714) 456-2308	bmbodenh@uci.edu
Ruth Mulnard, D.N.Sc., R.N.	Clinical Research Coordinator	(949) 824-7016	ramulnar@uci.edu
Larry Plon, Pharm.D.	Research Pharmacy Coordinator	(714) 456-5905	lplon@uci.edu
Madeleine Pahl, M.D.	Research Subject Advocate	(714) 456-8029	mpahl@uci.edu
Jenny Larson	Applied Physiology and Human Performance Lab Manager	(714) 456-2276	jlarson@uci.edu
Mandeep Brahmbhatt, BS	Administrative Assistant	(714) 456-2308	mbrahmbh@uci.edu

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