Regulations for Good Clinical Practice Article 17

The informed consent form and any other written information to be provided to subjects should be revised whenever important new information becomes available that may be relevant to the subject’s consent. The subject or the subject’s legally acceptable representative should be informed in a timely manner if new information becomes available.Any revised informed consent form, and written information shall be approved by the Ethics Committee in advance of use; For those clinical trials which are approved by the Competent Authority, the revised documents shall be resubmitted for approval.The communication and approval referred to in preceding paragraph1 and paragraph 2 should be made in writing.