Manual for the design of non-drug trials in primary care, taking account of Good Clinical Practice (GCP) criteria

被引：5

作者：

Joos, Stefanie ^{[1
]}

Bleidorn, Jutta ^{[2
]}

Haasenritter, Joerg ^{[3
]}

Hummers-Pradier, Eva ^{[4
]}

Peters-Klimml, Frank ^{[1
]}

Gagyor, Ildiko ^{[4
]}

机构：

[1] Univ Klinikum Heidelberg, Abt Allgemeinmed & Versorgungsforsch, Vossstr 2, D-69115 Heidelberg, Germany

[2] Hannover Med Sch, Inst Allgemeinmed, Hannover, Germany

[3] Philipps Univ Marburg, Abt Allgemeinmed Pravent & Rehabil Med, Marburg, Germany

[4] Univ Med Gottingen, Abt Allgemeinmed, Gottingen, Germany

来源：

ZEITSCHRIFT FUR EVIDENZ FORTBILDUNG UND QUALITAET IM GESUNDHEITSWESEN | 2013年 / 107卷 / 01期

关键词：

Non-drug trials; Good Clinical Practice; primary care; general practice; study design;

D O I：

10.1016/j.zefq.2012.12.019

中图分类号：

R19 [保健组织与事业（卫生事业管理）];

学科分类号：

摘要：

In recent years studies not falling under the German Pharmaceutical Law ("nondrug trials") have also been increasingly expected to be conducted according to Good Clinical Practice (GCP) in order to ensure that uniform standards are maintained for data quality and patient safety. However, simple transfer of the GCP criteria is not always possible and often not useful. Given the fact that research questions regarding non-drug interventions are common in primary care (e.g., general practice), the "Network for Clinical Studies in General Practice" has developed a manual for planning and conducting non-drug trials. This manual is based on the GCP guideline, taking account of the conditions and circumstances in primary care settings. Both structure and relevant content of the manual are presented in the article.

引用

页码：87 / 92

页数：6