Pilot study initiation package - The Netherlands-TU/e-Children & Young Adults

A Submission package, prior to enrolment of first study participant, containing:- the final version of the study protocol as submitted to regulators / ethics committee(s);- a registration number of the clinical trial in a WHO or ICMJE-approved registry;- regulatory and ethics (if applicable institutional) approvals required for the enrolment of the first study participant from ethics committees and national competent authorities if applicable.