Regulations for Good Clinical Practice Article 90

The investigator should not implement any deviation, or changes of the protocol without agreement by the sponsor and prior approval from the Ethics Committee, except where necessary to eliminate an immediate hazard(s) to trial subjects, or when the change(s) involves only administrative aspects of the trial.For a deviation, or a change of, the protocol implemented to eliminate an immediate hazard(s) to trial subjects, the investigator should submit the implemented deviation or change, the reasons for it, or the proposed protocol amendment(s) to the Ethics Committee and the sponsor, and to the Competent Authority if the trials are approved by the Competent Authority.