Quality by Design-The Value of CRF Mapping | August 19, 2015 10:00 AM - August 19, 2015 1:00 PM | Automation.com

Quality by Design-The Value of CRF Mapping

Event Summary

August 19, 2015
Fremont, CA 94536
United States
August 19, 2015 10:00 AM
August 19, 2015 1:00 PM
Online Compliance Panel
[email protected]
Click here to Visit


Quality by Design: The Value of CRF Mapping

Instructor: Glenda Guest
Product ID: 500959

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 data verification is one aspect of assuring such data integrity. As technology advances and medical records transition from paper based to electronic systems the clinical research community must adapt procedures to ensure reliable data are derived from electronic systems which may not support the limited access restrictions imperative for subject privacy as well as data reliability. Implementing Quality by Design (QbD) principles and CRF Mapping is one important method to consider.

Objectives of the Presentation
Describe the concept of Quality by Design (QBD)
Identify at least 3 factors that contribute to data quality failures
Summarize an acceptable approach for verifying accuracy of 'certified copies'
Apply concepts of Case Report Form mapping to enhance data integrity and reduce data collection inconsistencies

Who can Benefit
Clinical Investigators
Clinical Research Coordinator
Clinical Research Monitors
Project Managers
Clinical Quality Auditor

For Registration-

Note : Use coupon code 1371 and get 10% off on registration