Quality by Design-The Value of CRF Mapping 2015

Quality by Design-The Value of CRF Mapping Instructor: Glenda Guest Product ID: 500959 Description This session will describe the concept of Case Report Form (CRF) mapping and explain the potential benefits of implementing this procedure early in your clinical study planning activities. As medical records move from paper based to electronic systems throughout the world, the clinical research community struggles with issues such as direct access to the electronic source for monitors, auditors and even regulatory authorities. As a result a number of 'alternative' methods are being used to provide source documentation to support Case Report Form (CRF) data in clinical trials. Some examples include the use of source document worksheets, provision of "certified copies" of electronic source documents and using CRFs as a source. The result in many cases is duplication of effort, forcing site personnel to review and print off 'relevant' sources, increased risk of transcription errors and in many instances where there are multiple conflicting 'sources' for a given data point. In the spirit of Quality by Design (QbD) initiatives, research sites and sponsors need to work together to ensure accurate, reliable data are obtained and reported. Areas Covered The concept of Quality by Design from FDA perspective The attributes of Quality Data applicable to paper and electronic records FDA recommendations to optimize your data set The pitfalls of source document work sheets and 'certified' copies FDA's recommendations for Sponsors and Sites using a 'certified copy' process How CRF mapping contributes to data quality by ensuring consistency and reducing potential rework and regulatory risk A general process for implementing Case Report Form Mapping Concepts and techniques to facilitate adoption of QbD Data Set Optimization activities Why Should you Attend Assuring regulatory authorities of the integrity of clinical trial data is imperative to gaining approval for your products. Source