Audit Trail Review in GCP and GMP Systems – A Regulatory Requirement?

The need for an Audit Trail review as layed out in recent regulatory and guidance documents, must be analyzed and interpreted in the context of data collections in clinical trails. The requirements for source data in studies and the means of electronic data collection used seem to make a review of the audit trail necessary. The presentation will provide an overview on the regulatory requirements and the (potential) consequences for the data collection and analysis process in Studies. Problem Statement The presentation will provide an overview on the regulatory requirements for electronic data and systems and the (potential) consequences for the data collection and analysis process in Studies.