Research Support Services

UC Irvine's School of Medicine Research Support Services (SOMRSS) provides faculty members in the School of Medicine with resources, information and expertise in extramural funding to foster and facilitate the research enterprise within the medical school and the broader university community.

The SOMRSS provides a variety of pre and post-award research support services. These include proposal review for Dean’s endorsement, pre-and post-award administration, clinical trial budget development and payment term negotiations. and IRB/regulatory document preparation and submission.  Additionally, a myriad of education opportunities are available to keep UC Irvine's research community current on research best practices and current events.

If you have any questions or comments, please contact SOMRSS at somrss@uci.edu or 714.456.8708.

Services offered:

IRB/Regulatory Document Preparation Services

SOMRSS will guide your research protocol through the entire IRB approval process. We will develop and complete your entire IRB application, informed consent form and protocol narrative; generate hard copies; route for signatures and deliver to the IRB; coordinate responses to IRB pre-review & IRB review comments and submit them to the IRB; submit study to any other required UC Irvine committees for review (Scientific, Bio-Safety, Radiation Safety, Conflict of Interest, etc.); conduct regulatory document requirement review, preparation and submission. View service flow chart.

IRB Modifications/Amendments

SOMRSS will coordinate and submit all sponsor and department initiated modifications/amendments for the life of the study! (Open only to studies that utilized SOMOR IRB/Regulatory Preparation Services for initial approval.)

Budget Preparation and SPA Liaison Services

Preliminary budget preparation and negotiation. Serve as communication liaison with Sponsored Projects Administration and Clinical Research Finance. Coordination of approvals and signatures for submission to Sponsored Projects Administration. View services flow chart.

Budget Review Consultation Service

SOMRSS provides a free budget review service for departments. We review your internal budget relative to personnel, patient care and other non-personnel costs and make recommendations based on discussion of the Protocol.

Charges

Effective April 1, 2012, SOMRSS will increase our Clinical Trial fees as follows:

• Full IRB $2,200
• Budget Preparation $2,200
• Modifications (Minor Changes*) $250
• Modifications (Significant Changes**) $500
• Protocol Amendments $500
• Renewals $500
• FDA Filings (IND/IDE) $500

*Proposed changes do not significantly affect the study design or aims, or risk/benefit assessment of the study.<
**Proposed changes significantly affect the study design or aims, or risk/benefit assessment.
***This new fee structure applies to service requests received on or after April 1, 2012.

Service requests received prior to April 1, 2012 will remain on the old fee structure:

• Full IRB $1,500
• Budget Preparation $1,500
• Modifications $250
• Protocol Amendments $250
• Renewals $250

If you have any questions regarding our service charges, please contact SOMRSS at somrss@uci.edu or 714.456.8708.

Clinicaltrials.gov Administration

The FDA Amendments Act of 2007, enacted on Sept. 27, 2007 is a federal regulation requiring clinical trials that evaluate "health outcomes" be registered on a public website called Clinicaltrials.gov. FDAAA information. FDAA full text.