Study Initiation Package

Study initiation package (before enrolment of the first study participant) including: i) registration number of the clinical study ii)final version of study protocol as approved by the ethics committee (a data collection plan specifying the frequency, the needs and the responsibilities of data collection processes, a biospecimen collection plan specifying the frequency, the needs and the responsibilities of sample collection, processing, coding and storage and laboratory analysis procedures, iii) ethics approvals required for the enrolment of the first study participant.