Interesting question. May auditors and inspectors feel that the full consent form (that is all information given to the subject during the consent interview) which forms part of the consent document, should be retained in full by both the investigator and subject. The reasons for this are various. ICH GCP E6 4.8.11 states that:- "Prior to participation in the trial, the subject or the subject's legally acceptable representative should receive a copy of the signed and dated written informed consent form and any other written information provided to the subjects". Also ICH GCP E6 8.3.12 states that the investigator must file the "signed informed consent forms ,to document that consent is obtained in accordance with GCP". From this we can conclude that the investigator needs to be able to show what an individual subject consented to and what was the basis for their decision to participate. There have been Inspection findings in the past, based upon the fact that consent forms have been changed and/or annotated, without the IRB/IEC approving such changes. The presence of the full consent form, intact, gives some assurance that no such changes were made to the consent information that was signed by the subject. Also hopefully the retention of all pages will also give some assurance that the full and correct (approved) version of the consent form was used with this subject.