Research Pharmacy

PROJECT SUMMARY/ABSTRACT
The Research Pharmacy (Investigational Drug Service-IDS) Shared Resource (SR) was established to
support inpatient and outpatient clinical research conducted by investigators at the Sidney Kimmel
Comprehensive Cancer Center (SKCCC). The Research Pharmacy staff work in close collaboration with the
SKCCC Clinical Research Office, disease groups, individual investigators and the Weinberg Oncology
Pharmacy clinical staff to coordinate and facilitate the development, implementation and maintenance of
clinical trial protocols. Services provided by the Research Pharmacy include protocol consultation, clinical data
monitoring, investigational product management, participation in the electronic order set development process,
monitoring patient investigational product adherence, providing quality assurance activities, providing drug
information and drug-drug interaction reviews, IRB membership and resources to disease groups, and other
services to support the study teams. This SR is fully integrated within the SKCCC Oncology Pharmacy and is
an integral part of the SKCCC's research efforts. This integration allows for additional support to research
participants by incorporating pharmacy clinical specialists' expertise and collaboration with Oncology
Pharmacy staff and technology to support production.
The SR staff include a Pharmacy Division Director, an Operations Manager, four Clinical Research
Pharmacists, one Clinical Decision Support Pharmacist, two Certified Pharmacy Technicians and one Certified
Pharmacy Technician/Inventory Specialist. Pharmacy support is available to investigators and the research
teams for patient care services 24/7. The Research Pharmacy is compliant with Maryland Board of Pharmacy
regulations, United States Pharmacopeia (USP) Chapter 797, pharmaceutical sterile compounding regulations,
and with state, federal and Johns Hopkins Medicine Institutional Review Board regulations for the conduct of
research. Compliance with USP Chapter <800> will be fully instituted at the completion of upcoming pharmacy
renovations planned for fall 2021. Current areas of focus to improve services and provide exceptional care to
oncology study participants include medication safety initiatives, exploring new technology and innovative
practices, implementing clinical pharmacy services within the Developmental Therapeutics Clinical Research
Group (Phase I), supporting research expansion initiatives, and facilitating residency training of a nationally
accredited pharmacy residency program for investigational drugs and research.
SKCCC Managed Shared Resource
Reporting Period: January 1, 2020 to December 31, 2020

Grant Number: 5P30CA006973-62
NIH Institute/Center: NIH
Principal Investigator: Michael Carducci