IDS Pharmacy Loma Linda University Medical Center Office Desiree Wallace, Rph., PharmD Investigational Drug Service Loma Linda University Medical Center Department of Pharmacy 11262 Campus Street West Hall, Room 1313 Loma Linda, CA 92354 909-558-4500, x83773 909-558-0323 (fax) dwallace@llu.edu Shipping Attn: IDS Research Pharmacy Loma Linda University Medical Center 11223 Campus Street, Dock B Loma Linda, CA 92354 909-558-4500 909-558-4145 (fax)

Original Medical Records/Source Documentations/CRF’s • Electronic Medical Records utilized • Protected EMR work queue provided for monitoring • Experience with hard copy and electronic CRF’s • Examples: Inform, Phaseforward, Mednet Solutions, MediData

Monitoring Visits • Monitoring visity to be scheduled with coordinator 2+ weeks prior to visit • Designated monitoring space provided • Phone, fax, and copies available in Research Office • Internet access available

Department Study Drug Maintenance • Main door to storage locked-access by research staff only • Refrigerator for investigational product, temperature monitored daily • Freezer for investigational product: -20° C and -70º C • Locked storage cabinets for investigational products • Room temperature monitored daily

Department Laboratory • Freezer: -10 to -20° C • Fridge: 2 to 6° C • Dry Ice Available • Interdepartmental processing includes non-refidgerated centrifuge, special arrangements available for special processing • Four certified staff for Shipment of Biologicals and Dry Ice and Bloodborne Pathogens Local Laboratory Loma Linda University Medical Center 11234 Anderson Street Loma Linda, CA 92354 909-558-440

Emergency Measures • Crash Cart • Defibrillator • Oxygen • CPR Certified Staff • 911 is called in emergency Exam Rooms • 15 exam rooms, including two designated for research Contracts and Budget Information Budget Requirements • Institutional Overhead • Study Startup and Closeout Fees Contracts • Contract review runs concurrently with IRB review • 6-8 weeks to obtain fully executed contract Loma Linda University Health Care Clinical Trial Center, Coleman Pavilion 11113 11175 Campus Street Loma Linda, CA 92350 909-651-5002 909-558-0587 (fax) llu.edu/clinical-trials

Institution Signatory Anthony Zuccarelli, PhD Associate Vice President for Research Affairs Payee Information Loma Linda University Adventist Health Sciences Center 11175 Campus Street, CSP 11006 Loma Linda, CA 92354