Specific aspects of source medical documents in clinical studies on healthy volunteers

Autor:	S. B. Fitilev, I. I. Shkrebneva, A. V. Vozzhaev
Jazyk:	ruština
Rok vydání:	2018
Předmět:	клинические исследования здоровые добровольцы первичная медицинская документация специальные формы (шаблоны) clinical trials healthy volunteers source medical documents trial-specific forms Medical technology R855-855.5 Pharmacy and materia medica RS1-441
Zdroj:	Качественная клиническая практика, Vol 0, Iss 4, Pp 35-38 (2018)
Druh dokumentu:	article
ISSN:	2588-0519 2618-8473
Popis:	This article covers important aspect of methodology of clinical trials - source medical documents. Special attention is always paid to source medical records in phase 1 trials when the future of novel medicinal product is at stake. Authors discuss some issues of development and application of trial-specific forms as part of source medical documentation on the basis of practical experience in conducting phase 1 studies on healthy volunteers. Primary focus is on the structure and content of these forms with respect to specific procedures and study population in early phase research. Authors believe that implementation of trial-specific forms improves the quality of clinical trials.
Databáze:	Directory of Open Access Journals
Externí odkaz:	https://doaj.org/article/5bca22f643f543bf8f740d61d1aea43b Zobrazit plný text záznamu View record in DOAJ