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Chapter Law Content

Title: Regulations for Good Clinical Practice CH
Category: Ministry of Health and Welfare(衛生福利部)
Chapter VII Conduction of Clinical Trials
I. Clinical Trial Protocol
Article 89
The investigator and the institution should conduct the trial in compliance with the protocol agreed to by the sponsor, by the Ethics Committee and by the Competent Authority. The investigator, the institution and the sponsor should sign the protocol, or an alternative contract, to confirm agreement.
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.
Article 91
The investigator, or person designated by the investigator, should document and explain any deviation from the protocol.