Study initiation package

Study initiation package (before enrolment of the first study participant) including:o Registration number of the clinical study in a registry meeting WHO Registry criteria.o Final version of study protocol as approved by the regulator(s) / ethics committee(s).o Regulatory and ethics (if applicable, institutional) approvals required for the enrolment of the first study participant (In case of multicentre clinical studies, submission of approvals for the first clinical site is sufficient).