1. Clinical Resources: LLUMC Investigational Drug Service
5/14/2018
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. 5/14/2018
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
Investigational Drugs---refers to drugs used in human research that are Approved or those Not yet approved by the FDA
IDS staff: 17 yrs experience with over 500 ID studies; educate pharmacists to cover weekends/nights
GCP Consolidated Guidelines from International Conference on Harmonisation
CFR Part 50/DHHS Part 46-Protection of Human Subjects: PI is responsible for protecting subjects from harm while they are participating in their research protocol.
Part 56: IRB (Institutional Review Board)
Part 210 & 211 cGMP (current Good Manfacturing Practice)
Part 312-IND may be required if research on the use of a marketed drug intended to support sponsor’s change in labeling, advertising, or indications for use, a significant increase in risk, or change in dosage level or route of administration.
Part 314 NDA (New Drug Applications)
The most stringent of the laws should govern the conduct of use of the investigational drug….
>for the most part they are additive; GCP and CFR set the minimum standards to follow & your local laws and SOPs help define the details at your site

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 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
All records shall contain accurate reporting, verification and retrieval after archiving.
Labeling to Ensure Safe Use: (21 CFR Part 312.6)
“Caution: New Drug—Limited by Federal law to investigational use.”
USP 800 compliant by July 1st, 2018

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 c: 2 yrs after the date of approval for the indication (NDA) being investigated or not approved

5. 5/14/2018
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)
EDC-electronic data capture

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. 5/14/2018
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) , ext.83773
Pager (909) ,1505 or
Fax (909)
Backup: Norm Hamada, PharmD, RPh-Director of Clinical Pharmacy Services; x47386