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 firstname.lastname@example.org or 714.456.8708.
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.
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.
Effective April 1, 2012, SOMRSS will increase our Clinical Trial fees as follows:
*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:
If you have any questions regarding our service charges, please contact SOMRSS at email@example.com or 714.456.8708.
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.
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|Effective October 1, 2011: All proposals with subaward(s) included in the budget must send a completed SUBRECIPIENT COMMITMENT FORM to Sponsored Projects as part of the proposal package and AA form. Click here to download the form. This step will expedite the turnaround time for issuing subaward agreements at the award stage while remaining compliant with federal regulations.|
|According to new federal guidelines, research on archived human tissues which have been stripped of all patient identifiers no longer requires IRB approval.|
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