How to perform clinical examinations - an algorithm of procedure
Keywords:
Good Clinical Practice, Patient’s Rights, Bioethical CommitteeAbstract
For assurance of suitable quality of clinical investigation , the proper realization requires the stan-dardization of methodical performance. For estimation of algorithm during planning and performance of clinical investigations, the author has done the syntheses' of recommendations of Stowatryszenie na Rzecz Dobrej Praktyki Badati Klinicznych w Polsce, as well as the guidelines of Food and Drug Administration. The attention was paid on legal controls over safety of investigations as well as the rule of bioethical committees. It was introduced the rule of Good Clinical Practice ( GCP) in Poland. It was quoted guidelines of International Helsinki Federation for Human Rights (IHF) about patient's right, participating in clinical investigation.
Downloads
References
Romanowicz M., Idealne badanie kliniczne – co oznacza, jakie są jego składniki, co wpływa na pojęcie „jakości“ pracy badawczej? Stowarzyszenie na Rzecz Dobrej Praktyki Badań Klinicznych w Polsce, Warszawa, 2007.
Clarke J., Guide for clinical trial staff – implementing good clinical practice, Br J Clin Pharmacol. 2007, 8.
Bertoye P H.Courcier-Duplantier, S.Best, N. Adaptation of the application of goodclinical practice depending on the features of specific research Project. Therapie. 2006,4,271
Research ethics committees; good clinical practice; advance directives. Bull Med Ethics. 2005, 209, 8–11.
Dudziak J., Badania naukowe – podstawowe informacje, Komisja ds. SBN, Poznań, 2006.
Downloads
Published
How to Cite
Issue
Section
License
Copyright (c) 2008 Medical Journal of the Rzeszow University
This work is licensed under a Creative Commons Attribution 4.0 International License.
Our open access policy is in accordance with the Budapest Open Access Initiative (BOAI) definition: this means that articles have free availability on the public Internet, permitting any users to read, download, copy, distribute, print, search, or link to the full texts of these articles, crawl them for indexing, pass them as data to software, or use them for any other lawful purpose, without financial, legal, or technical barriers other than those inseparable from having access to the Internet itself.
All articles are published with free open access under the CC-BY Creative Commons attribution license (the current version is CC-BY, version 4.0). If you submit your paper for publication by the Eur J Clin Exp Med, you agree to have the CC-BY license applied to your work. Under this Open Access license, you, as the author, agree that anyone may download and read the paper for free. In addition, the article may be reused and quoted provided that the original published version is cited. This facilitates freedom in re-use and also ensures that Eur J Clin Exp Med content can be mined without barriers for the research needs.
