Download or read book GCP Auditing written by German Society for Good Research Practice and published by Editio Cantor. This book was released on 2003 with total page 171 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Due to the "Good Clinical Practice" (GCP) requirements the high demands of quality assurance internationally became an integral part in the conduct of clinical trials. The conducting of audits enables pharmaceutical companies, CROs, authorities etc. to verify whether the required standards are complied with. The methods used for the planning, conducting and evaluation of auditing measures are presented in detail. Thus this textbook provides the necessary material for both the audits as such and for their evaluation. Different fields of work are presented--investigator, clinic, laboratory and CROs. The subjects dealt with include the trial protocol, information for study participants, computer system validation, validation in clinical studies employing electronic data capture systems, audit schedule and audit report. The authors (members of a board of experts of the Deutsche Gesellschaft fur Gute Forschungspraxis, DGGF; German Society for Good Research Practice) work in the pharmaceutical industry or at CROs and have had many years of experience in the quality assurance field.