A Database Quality Review Process with Interim Checks

Abstract

Database quality reviews for clinical trial reporting databases are increasingly being performed within the pharmaceutical industry. It is well understood that an accurate reporting database is the foundation of obtaining meaningful inferences from a clinical study. The processing of clinical trial data is also mentioned in the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. The following article describes a database quality review process that uses a confidence limit approach, allowing one to develop a customized plan, and depends on the acceptance limits and the size of the study. Various issues concerning a database quality review are discussed, including which fields should be reviewed, how the fields should be counted, and how the sampling should be performed. Finally, early stopping rules are incorporated into the plan, as well as a technique for performing interim reviews without significantly increasing the overall resources for conducting the review.