Specific aspects of source medical documents in clinical studies on healthy volunteers
Abstract
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.
About the Authors
S. B. Fitilev
Peoples' Friendship University of Russia, Moscow, Russia
Russian Federation
Russian Federation
I. I. Shkrebneva
Peoples' Friendship University of Russia, Moscow, Russia
Russian Federation
Russian Federation
A. V. Vozzhaev
Peoples' Friendship University of Russia, Moscow, Russia
Russian Federation
Russian Federation
References
1. ГОСТ Р 52379-2005 «Надлежащая клиническая практика».
2. Мелихов О.Г. Клинические исследования. Изд. «Атмосфера», М. 2003.
3. Клинические испытания лекарств / под ред. Мальцева В.И., Ефимцевой Т.К., Белоусова Ю.Б., Коваленко В.Н. Изд. Киев, «Морион». 2002.
4. Guidelines for phase 1 clinical trials, 2012 edition, ABPI.
5. Приказ МЗ РФ от 15.12.2014 г. N 834н «Об утверждении унифицированных форм медицинской документации, используемых в медицинских организациях, оказывающих медицинскую помощь в амбулаторных условиях, и порядку по их заполнению».
6. Приказ Минздрава СССР от 04.10.80 N 1030 (ред. от 31.12.2002) «Об утверждении форм первичной медицинской документации учреждений здравоохранения».
Review
For citations:
Fitilev S.B., Shkrebneva I.I., Vozzhaev A.V. Specific aspects of source medical documents in clinical studies on healthy volunteers. Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice. 2016;(4):35-38. (In Russ.)
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