The Duty for Sponor Oversight in Clinical Trials

The first edition of the practical guide related to the topic The Duty for Sponsor Oversight in Clinical Research outlined the underlying requirements as well as possible approaches to implement it efficiently in small and mid-sized companies. This was based on a master's thesis released in April 2019. The next edition will focus on the Clinical Data Review which includes all aspects to be considered, for example, the outcome of the overall monitoring oversight activities. Furthermore, to describe and show examples of a standardized score assignment to ensure a unique process of the assessment.

Doris Breiner, MSc Consultant Clinical Research works since 2005 in the field of clinical research. In the meantime the focus was set on the quality aspects to ensure robust and reliable data to ensure the alignment with the regulatory requirements with regards to the data integrity.