Participation of a coordinating center pharmacy in a multicenter international study.
OBJECTIVE
The activities of a coordinating center pharmacy (CCP) supporting a multicenter, international clinical trial are described.


CONCLUSIONS
Serving in a research support role comparable to that of a commercial clinical trial supply company, a CCP within the Johns Hopkins Hospital Investigational Drug Service (JHH IDS) uses its management expertise and infrastructure to support multicenter trials, such as the recently completed Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage, Phase III (CLEAR III) trial. The role of the CCP staff in supporting the CLEAR III trial was overall investigational product (IP) management through coordination of IP-related operations to ensure high-quality care for study participants at study sites in the United States and abroad. For the CLEAR III trial, the CCP coordinated IP supply activities; provided education to site pharmacists; developed study-specific documents, including pharmacy manuals; communicated with trial stakeholders, including third-party IP distributors; monitored treatment assignments; and performed quality assurance monitoring to ensure compliance with institutional, state, federal, and international regulations regarding IP procurement and storage. Acting as a CCP for a multicenter international study poses a number of operational challenges while providing opportunities for the CCP to contribute to research of global importance and enrich the skill sets of its personnel.


CONCLUSIONS
The development and implementation of the CCP at JHH IDS for the CLEAR III trial included several responsibilities, such as IP supply management, communication, and database, regulatory, and finance management.
Department of Pharmacy, Johns Hopkins Hospital, Baltimore, MD. jjeon7@jhmi.edu.
Jihyun Esther
JE
Jeon
Department of Pharmacy, Johns Hopkins Hospital, Baltimore, MD.
Janet
J
Mighty
Division of Brain Injury Outcomes, Johns Hopkins School of Medicine, Baltimore, MD.
Karen
K
Lane
Division of Brain Injury Outcomes, Johns Hopkins School of Medicine, Baltimore, MD.
Nichol
N
McBee
Division of Brain Injury Outcomes, Johns Hopkins School of Medicine, Baltimore, MD.
Ryan
R
Majkowski
Emissary International, LLC, Austin, TX.
Steven
S
Mayo
Division of Brain Injury Outcomes, Johns Hopkins School of Medicine, Baltimore, MD.
Daniel
D
Hanley
D002543:Cerebral Hemorrhage / Q000175:diagnosis / Q000453:epidemiology* / Q000628:therapy*; D003131:Combined Modality Therapy / Q000379:methods / Q000592:standards; D004311:Double-Blind Method; D006801:Humans; D038622:Internationality; D009934:Organization and Administration / Q000592:standards; D010595:Pharmacists / Q000592:standards; D010607:Pharmacy Service, Hospital / Q000379:methods* / Q000592:standards; D010959:Tissue Plasminogen Activator / Q000008:administration & dosage
D010959:Tissue Plasminogen Activator