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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
V. Multicenter Trials
Article 117
When conducting a multicenter trial, all investigators should conduct the trial in compliance with the protocol agreed to by the sponsor and approved by the Competent Authority, and by the Ethics Committee.
Article 118
When conducting a multicenter trial, for those investigators who are collecting additional data according to the protocol, the sponsor should provide supplemental CRFs that are designed to capture the additional data.
Article 119
The coordination approaches and responsibilities of the investigator(s) and the other participating investigators should be documented in writing prior to the start of a multicenter trial.
Article 120
When conducting a multicenter trial, all investigators should comply with a uniform set of standards for the assessment of clinical and laboratory findings, and on completing the CRFs.
Article 121
When conducting a multicenter trial, the sponsor should facilitate communication between all investigators.