Abstract
A large number of clinical documents are generated during the clinical stage of drug development. These documents are used to obtain regulatory permission for clinical trial initiation, to execute clinical trials, and eventually to get regulatory approval for new products or indications. The types of clinical documents required are numerous and complex and include study protocols, informed consent forms, investigator brochures, investigational new drug annual reports, and clinical study reports. In addition, clinical documents that summarize clinical study results are part of a new drug application or biological license application. Because clinical documents are critical for drug development and business, they must be of the highest quality. Towards that end, we have developed a comprehensive QC program and implemented a QC step in the clinical document preparation process. This program is process driven with an SOP for QC review and a QC step is formalized in each documentβspecific SOP. We also applied quality audit principles in the QC review. Independent reviewers perform each QC review using checklists to provide a consistent and objective evaluation of clinical documents. The document author addresses each QC finding and subsequent QC changes are verified. The scope of a QC review is tailored to each document. The QC review is an inherent step of the clinical document preparation process, providing necessary assurance that clinical documents generated are of the highest quality possible. Copyright Β© 2011 John Wiley & Sons, Ltd.