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Clinical Resources: LLUMC Investigational Drug Service

Learn about LLUMC's Investigational Drug Service, available for research collaboration. Follow regulations and procedures for drug storage, administration, and more. Contact for further inquiries.

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Clinical Resources: LLUMC Investigational Drug Service

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  1. Clinical Resources:LLUMC Investigational Drug Service • Desiree Wallace, Pharm.D. • Objectives: • To describe the availability of the IDS for research on campus • To discuss how one can collaborate and access the IDS to enhance research activities 2016 Research Affairs Symposium October 21, 2016 LLUMC Department of PharmacyTrial Center

  2. IDS Overview • Activities centralized in UH Central Hospital Pharmacy, 2nd floor • IDS Coverage M-F 8-4:30 (1FT Pharmacist & 1FT tech), Pharmacist Supervisor on duty after hours & weekends • Assist Coordinator (s) and Site Investigator(s) with conducting an ID protocol • InPatient: all study drugs administer in UH, CH, SH, EC must be processed through the IDS Pharmacy • OutPatient: as requested by sponsor/investigator • Any Type of Study: Open-Label, Randomized, Placebo-Controlled, Single/Double-Blind, Investigator Initiated • Adhere to Regulations/Policies: • E6 (ICH)-Good Clinical Practice • Food & Drug Administration (FDA): Title 21 CFR Part 50, 56, 210 & 312 DHHS Title 45 CFR Part 46 • State of CA Requirements CA Board of Pharmacy Law • Institutional Policies & Procedures (421-R2, R1, Q29) • LLU IRB Board Member

  3. IDS • Protocol Evaluation: review feasibility of IDS participation, budget, letter of agreement, EPIC requirements, staff education • Routes of Administration: intravenous, oral, topical, hazardous/chemotherapy, controlled substances • Storage: in Separate area from commercially available drugs, Secured Location with Limited Access • Temperature Monitoring: daily with certified calibrated device @ room-temperature, refrigerated, frozen, excursion reporting; preferably continuous with excursion alarms & procedures established • Storage Equipment: refrigerator/freezer maintained/inspected by clinical engineering • Transport: Chain of Custody/Cold Chain documentation & temperature monitoring during transport • Packaging/Labeling: OL or Blinded; per CA Rx Law (“Caution: New Drug—Limited by Federal law to investigational use.”); special precautions; child proof • Preparation: non-aseptic, aseptic in ISO class 5 (hazardous/chemo) or laminar flow hood in USP 797 compliant facility

  4. IDS • Randomization: experience with many IVRS/IWRS systems, manually, Rx generated lists • Dispensing: Inpatient/Outpt EPIC/Willow/BEACON formulary build requests or treatment plan build • Drug Accountability: manual paper forms or electronically; all study drug must be reconcilable • Inventory: ordering, receipt, transfer, returns/compliance by subject, expiration dating • Disposal: on site per SOP T-9 or return to sponsor • Regulatory: maintain current Protocol/IB, IRB approval, ICD, amendments, investigator/sub-I’s, billing • Monitoring, Audits and Closeout (Sponsor/CRO, FDA, DEA) • Record Retention: 21 CFR 312.57c: 2 yrs after the date of approval for the indication (NDA) being investigated or not approved

  5. IDS Collaboration • Investigator may contact IDS directly for ?’s (see contact info) • CTC feasibility analysis: will help determine the need for IDS ancillary department • IDS works with CTC on LOA to Participate & Financial support • IDS will determine feasibility based on information provided by the investigator from the Sponsor & SEV (Protocol, IB, Pharmacy Manual, Operating Manual, IWRS/EDC)

  6. Conclusion • IDS resource is available to help the PI with the responsibility of Managing Investigational Drugs • IDS will collaborate with CTC, the Investigator, Coordinator & Sponsor to assure that the protocol, regulations, laws & P&P’s are followed to ensure the safety of human subjects. • IDS will ensure that all Investigational Drugs are fully managed and accounted for.

  7. Questions?

  8. Contact Information: • Desiree Wallace, Pharm.D.,RPh, Investigational Drug Pharmacist • Mayra L. Gonzalez, CPhT, IDS Pharmacy Technician • SHIPPING ADDRESS: Loma Linda University Medical Center Investigational Drug Service, Department of Pharmacy 11223 Campus Street, DOCK B Loma Linda, CA 92354 • Office: LLU School of Pharmacy, Shyrock Hall Rm 228 (909) 558-4000, ext.83773 Pager (909)558-1717,1505 or dwallace@my2way.com Fax (909)558-0323 email: dwallace@llu.edu • Backup: Norm Hamada, PharmD, RPh-Director of Clinical Pharmacy Services; x47386

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