Clinical Data Quality - Ensuring Clinical Data Consistency and Quality

Why Should You Attend:

Clinical data pass through many hands, from investigative site to sponsor/CRO to submission to FDA and/or publication. Sponsors, CROs, agencies etc., and their various departments, have different expectations of the data based on how they use it, but little understanding of each others’ needs, nor what each does to or with the data. This may lead to the data being handled or used improperly. The implication is that significant decisions are being made based on data of unknown quality.

This 90-minute session will review the mechanisms each organization/department uses to ensure data quality and the gaps those mechanisms leave. The sepaker will discuss examples of these gaps and their implications. You will learn how different departments or teams can achieve a shared understanding of the true quality of data and thereby ensure decision making based on high-quality data, that is “data that are fit for their intended purpose”.

Areas Covered in the Seminar:

• Defining “data quality”.
• How each organization sees data quality in their own context.
• The mechanisms each organization/department uses to ensure data quality and the gaps those mechanisms leave.
• Examples of these gaps and their implications.
• Who has access to what quality documents at what point in the process and how useful they are?
• Why the FDA reviewers are, in some ways, the least able to assess the quality of the data?