5.16 Safety Information

5.16.1 The sponsor is responsible for the ongoing safety evaluation of the investigational product(s).

5.16.2 The sponsor should promptly notify all concerned investigator(s)/institution(s) and the regulatory authority(ies) of findings that could affect adversely the safety of subjects, impact the conduct of the trial, or alter the IRB/IEC’s approval/favourable opinion to continue the trial.