First study subject approvals package

Includes final version of study protocol as approved by first regulator/ethics committee(s), registration number of clinical study in a WHO- or ICMJE- approved registry and the approvals required for the enrolment of first subject in at least one clinical centre according to EU and national legislation. Study protocol will be developed by SERMAS in collaboration with CTUs and EFPIA partners according to ICH-E6(R2) “Guideline For Good Clinical Practice”. Due date will relate to the Commit Decision to GO (CDGO) for each FTIH trial plus 4 months.