Regulations for Good Clinical Practice Article 50
The sponsor is responsible for securing agreement from all involved parties to ensure direct access to all trial related sites, source data/ documents, and reports for the purpose of monitoring and auditing by the sponsor, and inspection by the Competent Authority.
中文原文 藥品優良臨床試驗作業準則第50條
試驗委託者應負責取得試驗機構之同意，直接監測和稽核試驗相關場所、原始資料、文件及報告，並可接受主管機關查核。