MCG Health System

OCIS Review Office

What is this service?

This is a review of clinical research studies prior to obtaining signatures and final approval.  The purpose is to ensure adherence with institutional requirements and to verify the proper allocation of resources and costs associated with each study.  The overall goal of the review is to expedite the research approval process by having items properly addressed prior to study start-up.  There is no charge for this service.

What studies need to be reviewed?

All studies that utilize MCG Health System resources.  The MCG Health System is comprised of MCG Health, Inc. and the clinical services offered by the faculty of the MCG School of Medicine and members of the Physicians Practice Group.

Resources include hospital facilities, the clinical research pharmacy, radiology, pathology, patients and their derived material such as tissue, blood and protected health information.

The Dean for the School of Medicine has determined that all School of Medicine studies that require Institutional Review Board approval need to go through the review process.

Additional types of studies may be included at the discretion of the Dean of each school.

How does this service work?

The OCIS Review service analyzes different components of the study start-up process.  This includes a study feasibility checklist, contracts, study protocols, budgets, and IRB submissions.  The OCIS makes recommendations to the investigator and research staff to help facilitate the clinical study approval process for their studies.

What is the review process?

Study approval components are submitted to the OCIS prior to any routing for signature and approval.  Whenever possible, items should be sent via email to the OCIS. The Review Process Guide provides a step-by-step description of the process and links to all the forms you will need for a complete study review.

What is the turn-around time?

Beginning September 1, 2008, the timeline for turning in Human Assurance Committee submissions to the OCIS Review Office will be the close of business the Monday prior to the HAC submission deadline.

Submissions will continue to be reviewed in the order received.  An email notice is sent to the investigator and study contact person upon receipt of the item.  Another email notice is sent that outlines the review recommendations and the next steps to take.  Review recommendations will be provided no later than 2-3 days of a complete submission.   This new timeline should provide research staff with sufficient time to make any changes and corrections prior to routing HAC submissions for signature.  HAC submissions received after 5 p.m. on Monday can not be guaranteed the 2-3 day turn around time.

Also, please remember to include the new HAC/OHRP fees on study budgets.

I need additional help to set-up my study!

Click on Resources to obtain information on scheduling study patients and billing tips.  There is also information on requesting access to patient's electronic medical records, how to pay investigators for their research services, and helpful links to other research-related sites.

How can I talk to a live person?

Call us at 706-721-6247.  Drop by or schedule an appointment.  We're here to help!

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Research at MCG  |  Medical College of Georgia
Please email comments, suggestions or questions to: Barbara Covington.

September 3, 2008