We are pleased to announce the release of a new course: Assuring Data Integrity in Clinical Research

Pharmaceutical, biotechnology and medical device companies and clinical researchers need to assure regulatory authorities of the reliability of the data that they generate during product development and testing – that is, to demonstrate data integrity. Practices that provide assurance of data integrity in clinical research are required by law and/or established as expectations in regulatory guidance. The data are reviewed in regulatory applications or during regulatory inspections of clinical trial sponsor and investigational sites. Inadequacies of data integrity are frequently reported by inspectors and result in regulatory actions against the organizations or individuals concerned. This course explains the requirements and describes principles and practices that should be followed by trial sponsors, investigators and other clinical research personnel to assure regulators of data integrity.

ICT03: Assuring Data Integrity in Clinical Research