Informed consent verification

Verification of informed consent forms for all trial participants is a key task during audits. The auditor should check if an informed consent form is present for all trial subjects and has been signed by the subject and the investigator prior to any trial-related activity. 

Inspectors will visit the investigator site and may possibly wish to visit the sponsor s office. They will review the documentation of the study file (see Box 7.1). Approval documents of the lEC will be compared with any amendments made to the protocol or to the subject s information sheet/ICR Consent forms for the study subjects will be inspected to establish who actually gave consent and whether this was before entry into the clinical study. A thorough source data verification of the CRF with the source documents, including the medical records, will be undertaken. Documentation relating to drug accormtability wiU be matched with each subject s CRF The facilities wiU be reviewed and the site staff interviewed. Further information can be obtained from... 

The specific device should be mentioned on the schedule, the consent, and the surgeon s preoperative evaluation of the patient. This information should be checked for its presence and agreement with all the documents in the preoperative verification. 

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