TY - JOUR
T1 - Cigarette Management System
T2 - An operating procedures guide to obtaining and managing investigational tobacco products for regulatory science research
AU - Kazi, Abid
AU - Fazzi, Alyse
AU - Krebs, Nicolle M.
AU - Merchlinski, Aimee J.
AU - Kline, Brenda
AU - Veldheer, Susan
AU - Richie, John
AU - Foulds, Jonathan
AU - Lane, Tonya
AU - Donny, Eric C.
AU - Muscat, Joshua
N1 - Funding Information:
Supported by the National Institute on Drug Abuse of the National Institutes of Health and the Center for Tobacco Products of the U.S. Food and Drug Administration under Award Number P50 DA036107 and U54 DA031659. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health or the Food and Drug Administration. Participants at the Penn State University site are seen at the Clinical Research Center supported by the Penn State Clinical & Translational Research Institute, Pennsylvania State University CTSA, NIH / NCATS Grant Number UL1 TR000127 and TR002014.
Funding Information:
Supported by the National Institute on Drug Abuse of the National Institutes of Health and the Center for Tobacco Products of the U.S. Food and Drug Administration under Award Number P50 DA036107 and U54 DA031659. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health or the Food and Drug Administration. Participants at the Penn State University site are seen at the Clinical Research Center supported by the Penn State Clinical & Translational Research Institute, Pennsylvania State University CTSA, NIH/NCATS Grant Number UL1 TR000127 and TR002014.
Publisher Copyright:
© 2018
PY - 2018/9
Y1 - 2018/9
N2 - Investigational tobacco products, specifically variable nicotine content research cigarettes (SPECTRUM), are available through the National Institute of Drug Abuse Drug Supply Program. Randomized controlled trials using research cigarettes are intended to support tobacco regulatory science research. The current paper provides an in-depth look into managing research cigarettes for two multi-site clinical trials and the design of a computer-based Cigarette Management System (CMS). The paper provides guidance intended for any investigator using similar products on the operating procedures under Good Clinical Practice standards and describes features of the CMS. The CMS and procedures described have been field tested for the past three years and have dispensed over 160,000 cigarette packs to participants. The CMS can accommodate a range of practical issues with real-world study implementation making it a robust application that is scalable to any study.
AB - Investigational tobacco products, specifically variable nicotine content research cigarettes (SPECTRUM), are available through the National Institute of Drug Abuse Drug Supply Program. Randomized controlled trials using research cigarettes are intended to support tobacco regulatory science research. The current paper provides an in-depth look into managing research cigarettes for two multi-site clinical trials and the design of a computer-based Cigarette Management System (CMS). The paper provides guidance intended for any investigator using similar products on the operating procedures under Good Clinical Practice standards and describes features of the CMS. The CMS and procedures described have been field tested for the past three years and have dispensed over 160,000 cigarette packs to participants. The CMS can accommodate a range of practical issues with real-world study implementation making it a robust application that is scalable to any study.
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U2 - 10.1016/j.conctc.2018.05.006
DO - 10.1016/j.conctc.2018.05.006
M3 - Article
C2 - 30023460
AN - SCOPUS:85048265381
SN - 2451-8654
VL - 11
SP - 69
EP - 74
JO - Contemporary Clinical Trials Communications
JF - Contemporary Clinical Trials Communications
ER -