Regulations for Good Clinical Practice Article 63
The sponsor should update the Investigator's Brochure as significant new information becomes available.
中文原文 藥品優良臨床試驗作業準則第63條
發現與試驗藥品有關之重大新資訊時，試驗委託者應立即更新主持人手冊。
English translation for reference only; the Chinese text prevails. Not legal advice.