The changes are with the consideration of the ICH E6(R2), key changes are:
Article 23: sponsor’s subsidies and payments provided to subjects;
Article 30: qualifications and abilities of the investigator
Article 37: responsibilities of the investigator
Article 54: sponsor’s appointment of personnel
Article 55, sponsor’s implementation of an electronic data processing system.
Article 73: about the responsibility of the sponsor for monitoring plans.
For more information, please refer to
藥品優良臨床試驗準則部分條文修正條文
http://regulation.cde.org.tw/doc_data_display?sid=2939&doctype2=