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巴尔干临床研究注册中心:由波斯尼亚和黑塞哥维那医学科学院设立。

Balkan Clinical Research Registry: Established by Academy of Medical Sciences of Bosnia and Herzegovina.

机构信息

Academy of Medical Sciences of Bosnia and Herzegovina, Sarajevo, Bosnia and Herzegovina.

World Academy of Art and Science, Washington, USA.

出版信息

Med Arch. 2020 Dec;74(6):412-415. doi: 10.5455/medarh.2020.74.412-415.

Abstract

BACKGROUND

From 2013 the World Medical Association's Declaration of Helsinki explicitly requires pre-registration of a study involving human subjects. The registration gives a chance for improvement of design and avoidance of bias.

OBJECTIVE

The aim of this article was to describe process of bearing decision to create regional registry of clinical studies for Balkan countries.

METHODS

After finding relevant studies about research registries and designing the concept and structure of future regional registry an article was published in IJBH journal. The article was than used as basis for discussion at 2020 meeting of Academy of Medical Sciences of Bosnia and Herzegovina (AMSBH), and final decision was made by the Academy to create the research registry.

RESULTS

Regional registry of clinical studies will be under the auspices of AMSBH and web-based, with the option of online registration of new studies. The data required to be entered in the moment of registration relate to key elements of research plan: topic, variables, sample, type of the study and the study population. After applying for registration of a clinical study, the authors will soon receive the review made by the AMSBH expert committee. The application could be accepted, rejected or returned for major or minor revision. After an application is accepted, it will be deposited in the searchable database and given the registration number.

CONCLUSION

The AMSBH's decision to create the regional registry of clinical studies will satisfy needs of researchers from Balkan countries in the first place, who share cultural and lingual similarities. It will also help with increasing standards of clinical research in the region.

摘要

背景

自 2013 年起,世界医学协会的《赫尔辛基宣言》明确要求对涉及人体受试者的研究进行预先注册。注册为改善设计和避免偏倚提供了机会。

目的

本文旨在描述为巴尔干国家创建临床研究区域注册中心的决策过程。

方法

在找到有关研究注册的相关研究并设计未来区域注册的概念和结构后,在 IJHB 期刊上发表了一篇文章。该文章随后作为 2020 年波黑医学科学院(AMSBH)会议讨论的基础,并由科学院最终决定创建研究注册中心。

结果

临床研究区域注册中心将由 AMSBH 主办,采用基于网络的方式,并提供新研究的在线注册选项。在注册时需要输入的数据与研究计划的关键要素有关:主题、变量、样本、研究类型和研究人群。在申请临床研究注册后,作者将很快收到 AMSBH 专家委员会的审查意见。申请可以被接受、拒绝或退回进行重大或次要修改。申请被接受后,它将被存入可搜索数据库并获得注册号。

结论

AMSBH 创建临床研究区域注册中心的决定将首先满足巴尔干国家研究人员的需求,他们具有文化和语言上的相似性。它还将有助于提高该地区的临床研究标准。

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