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

Abstract

In recent years studies not falling under the German Pharmaceutical Law ("non-drug 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. (As supplied by the authors).