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.




This questionnaire is meant to gather information on the specific rules and challenges of regulatory in your country. The questions focus on the submission on a national level (not on center-specific submission)

The goal is to create a unified central submission repository for retrospective and observational multinational studies


The completion of this questionnaire will take you circa 10 minutes.

There are 36 questions in this survey.