The stipulation of an insurance policy must take place before the study can officially start. The Insurance policy is typically requested for an Interventional study to cover the intervention that is not recognised as standard practice. The process for a study starts with the requesting of a quotation according to the insurance brokers requests. The following information is usually needed: copy of study protocol or synopsis, number of patients to be enrolled, their distribution among the participant countries, expected start and end dates of the trial, and Informed consent form (ICF). Price quotations must be obtained by a broker or directly from the Insurance company and greenlighted by the Sponsor. Typically the Insurance policy stipulation can be bonded to the approval of the Study by the Central Ethic committee.
