Data Integrity - The role and impact of Quality Assurance Compliance and Validation

This meeting will be held at the MBC Offices, located on the ninth floor of One Cambridge Center, Cambridge, MA 02142.

Overview

Regulatory Compliance is an integral part of the clinical trial process and applies to all functions within Clinical Development. Data Management and Biostatistics groups are no exception and the impact of compliance should be taken into consideration as trial activities are planned. These 2 presentations will provide overviews from a Clinical GCP and validation perspective.

Presenters and Topics

Clinical QA - A GCP Point of View

Quality Assurance of clinical data is more than verification of the data integrity. It is also verification of the processes and systems used not only by data management but by the vendors that generate specific clinical data to be used for analysis. This presentation will discuss audit processes of vendor generated data and clinical data management systems from a clinical QA GCP point of view.

Linda Del Paggio, GCP Consultant

Data Integrity: Impact of Validation in Data Management & Statistics

Regulations specify that clinical study data should have integrity. What does this mean? And, how does it affect the way a study is conducted, the data reported, and the results compiled into a clinical study report, and ultimately to a health agency submission. There are a number of expectations behind the simple phrase "data integrity" which if not met, make study outcomes difficult to analyze, or, reduce a submission to non-approvable. This presentation will discuss validation and data integrity expectations in the areas of data management and statistics and will highlight some common opportunities for improvement.

Joanne Malia, Purdue Pharma, Associate Director, Medical Research Process Management