Pursuant to SOP “Requirements to presentation of a file and presentation procedure”, documentation regarding an intended clinical study shall be submitted to the Committee on behalf of the person responsible for scientific, organizational and ethical aspects of the trial. The file submitted for the purpose of ethical expert examination of that trial must include documents required and significant for conduct of an adequate expertise.

Period and address of presentation

The documents shall be submitted to the secretarial office of the Committee in paper, in a single copy, within the period of one week prior to the regular meeting of the Committee.