Quality by Design: The Value of CRF Mapping

Duration: 60 Minutes
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.
Case Report Form
Instructor: Glenda Guest
Product ID: 500959

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
$300
Recorded Session for one participant
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Instructor Profile:
Glenda Guest is the Vice President of Norwich Clinical Research Associates Ltd. (NCRA), a full service Clinical Contract Research Organization (CRO) serving the pharmaceutical, medical device, biologics and nutritional product industries since 1994. She specializes in medical device monitoring and project management, auditing and training on US regulated research, quality systems and Good Clinical Practices in clinical research settings as well as for professional organizations.

Her auditing experience includes GCP auditing, independent third party, pre-PMA audits, Japanese GCP preparation audits and includes corrective action recommendations. She provides SOP development assistance and staff training related to correcting audit deficiencies.

Ms. Guest has maintained her status as a Registered Quality Assurance Auditor - Good Clinical Practices (RQAP-GCP) through the Society of Quality Assurance since 1997. She is a published writer, trainer and invited speaker at local and global professional meetings.
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