کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
8519150 | 1556786 | 2018 | 22 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Cigarette Management System: An operating procedures guide to obtaining and managing investigational tobacco products for regulatory science research
ترجمه فارسی عنوان
سیستم مدیریت سیگار: یک روش عملیاتی جهت دستیابی و مدیریت محصولات دخانیات تحقیقاتی برای تحقیقات علمی نظارتی
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موضوعات مرتبط
علوم پزشکی و سلامت
داروسازی، سم شناسی و علوم دارویی
علوم دارویی
چکیده انگلیسی
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.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Contemporary Clinical Trials Communications - Volume 11, September 2018, Pages 69-74
Journal: Contemporary Clinical Trials Communications - Volume 11, September 2018, Pages 69-74
نویسندگان
Abid Kazi, Alyse Fazzi, Nicolle M. Krebs, Aimee J. Merchlinski, Brenda Kline, Susan Veldheer, John P. Jr., Jonathan Foulds, Tonya Lane, Eric C. Donny, Joshua E. Muscat,