Research Review Service
WHAT is the review service?
The purpose of this service is to review clinical research studies in order to ensure adherence with institutional regulations and policies. The OCIS Review Office will help verify the proper allocation of all resources and expenses associated with clinical research studies.
What are the GUIDELINES?
Clinical research studies that are to be included in this review are:
- All studies that utilize MCGHI resources.
- All studies that utilize patients recruited from MCG Health System* facilities or use patient tissue and/or protected health information obtained from a MCG Health System facility, or any other MCG Health System resource regardless of where the study is conducted.
*MCG Health System is the health system of the Medical College of Georgia and is comprised of MCG Health, Inc. and the clinical services offered by the faculty of the School of Medicine and the members of the Physicians Practice Group.
- Additional types of studies may be included at the discretion of the Dean of each school. The Dean of the School of Medicine has determined that all of its clinical research studies requiring IRB approval will go through this process..
The overall goal of the review is to expedite the research approval process by having items properly addressed prior to routing for signature and official approval. There is no charge for the OCIS review services.
HOW does the review service work?
The OCIS review service analyzes study feasibility checklists, sponsor contracts, study protocols, budgets, and IRB submissions, to ensure that all items are in order and that proper arrangements for all ancillary services, including MCGHI services, have been made prior to study start-up. The OCIS review service makes recommendations to the investigator and research staff to help facilitate the clinical study approval process for their studies.
WHERE is this service located?
The OCIS review office is located on the 8th floor of the Adult Hospital (Room BB-8514). All study information ready for review can be submitted via email: OCIS@mcg.edu or dropped off at the OCIS review office.
WHAT is the review process?
The study components listed below are submitted to the OCIS review office prior to any routing for signature and approval. Whenever possible, items should be sent via email to the OCIS.
- As the first step, the investigator or designated research staff member completes the Study Feasibility Checklist and submits it along with the protocol (or summary) and the sponsor’s proposed budget to the OCIS review office. The study feasibility checklist is required for funded clinical trials where human subjects will participate in study visits. The checklist is not required for other types of research studies.
- The original study contract/agreement is submitted to the OCIS review office with the Contract Cover Sheet.
- The MCGRI/MCGHI budget is submitted to the OCIS review office prior to obtaining any signatures on the extramural routing form.
- One complete IRB submission packet is submitted to the review office prior to submission to the IRB. Review of the IRB packet does not guarantee IRB approval of the study. The goal of the IRB review is avoid unnecessary stipulations and delay of IRB approval.
Please note: These components do not have to be submitted to the OCIS review service at the same time. After the Study Feasibility Checklist and protocol are submitted, the other components can be submitted as soon as the items are ready for review. Please check the required Research Review Items Checklist to be sure that you have all the items for each component.
What is the turn-around time?
Each submitted component that is complete should take less than 2.5 workdays to be reviewed. Within this time period, an email notice will be sent to the investigator and their designated research staff member explaining the review status of each item.
The HAC submission deadline for full review is the second Monday of each month (except in November and December). In order to make any changes and obtain signatures in a timely manner, there is the following deadline:
Studies that require HAC review by the OCIS need to be submitted to the Office by 4 p.m. on the Wednesday prior to the HAC submission deadline. Studies submitted to the OCIS by 4 p.m. on the Wednesday prior to the HAC submission deadline are guaranteed to receive the OCIS Review recommendations no later than noon the following Monday. OCIS Review turnaround time is not guaranteed for studies submitted after 4 p.m. on Wednesday.
However, if a late submission to the OCIS is completed in time to meet the HAC deadline, all OCIS recommendations will be forwarded to the HAC. The reason for this is that the members of the HAC would like to see that all appropriate corrections have been made to the HAC submission documents prior to their review.
WHERE can I get more information?
www.mcg.edu/OCIS or call the OCIS Review Office at 721-6247.
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