Every artifact that is specifically identified in chapter 8 of ICH GCP has the relevant citation listed. In addition, where text elsewhere in the ICH guideline refers to a trial artifact, that citation has also been listed. For example, ICH section 4.12 discusses the need for the investigator to notify the IRB/IEC of trial termination. Therefeore, 4.12 is cited against artifact 03.03.03 ‘Notification of Trial Termination’ in the Reference Model.
July 2, 2014