Roadmap for the European Network of Gynaecological Trial groups (ENGOT) Trials.

摘要: The European Network for Gynaecological Oncological Trial groups (ENGOT) is a research network of the Society Oncology and was founded in Berlin October 2007. Earlier, we reported on ENGOT minimal requirements trials between academic pharmaceutical companies. In this paper, summarize roadmap performing framework. roadmap, define how an trial should be set up discuss following items: What are conditions to classify study as trial? protocol? How protocol, informed consent (ICF), case report form (CRF) produced? center selection feasibility performed trials? regulatory operational tasks handled? confidentiality agreement industry whole negotiated? contracts made groups? funding, insurance, communication flow ar- ranged conducting substudies what leading group A template agreement, checklist criteria new proposals, guidelines authorship also provided.