5.2 Delegation of responsibilities
The sponsor is responsible for agreeing with the investigator(s)
on the allocation of protocol-related responsibilities, including data
processing, breaking of the trial code, handling of statistics, preparation of
trial reports, and preparation and submission of documentation to the ethics
committee, the drug regulatory authority, and any other required review bodies.
This agreement should be confirmed in writing (protocol, contract, or
alternative document) prior to the trial.
The sponsor may transfer any or all clinical trial-related
activities to a scientific body (commercial, academic, or other), or to a
contract research organization (CRO). Any such transfer should be documented in