Centralizing SOP’s for trial submission in multinational collaborative research.

International collaboration is what has made ECCO growing over the last two decades. ClinCom wants to foster and support multi-national research in Europe. Strict and complex regulations are often an important hurdle for the initiation of international research collaborations. For prospective interventional trials EMA has now set up a central submission framework. However, for retrospective and observational studies there is not such a framework available yet. National study groups have experienced these challenges of regulatory, IRB submission and data-transfer agreements over the last years when initiating clinical trials.

As each country has its specific rules we would like to collect all the country specific submission information and make this available for all national study groups that are member of ECCO. In this context we have set up a questionnaire.