Keyword Suggestions

Results
 
 
Account Login
 
ACRP User E-mail Address
 
 
 
ACRP Password
 
 
 
 
 

Library Navigation

 
 

Browse Conferences

 
 

Topic Categories

 
 
 
rating
4-5 - Quality by Design: The Value of CRF Mapping 
$75.00
Purchase
Member Price:
$25.00
Date/Time:
April 17, 2016   10:45am - 11:45am
 
Total Credits:
1.0 CH  
 
Format:
       
  Synced Audio / Video / Slides
 
Share:
 

As medical records move from paper-based to electronic systems worldwide, the clinical research community struggles with the challenges of direct access to the electronic source for monitors, auditors and regulatory authorities. Alternative methods have evolved, such as source document worksheets, provision of "certified copies" of source and using CRFs as a source. This may result in duplication of effort by forcing personnel to review and print 'relevant' sources, increased risk of transcription errors and multiple conflicting 'sources' for a given data point. In the spirit of Quality by Design initiatives, sites and sponsors need to work together to ensure accurate, reliable data are obtained and reported. Explore the concepts of Quality by Design and Case Report Form mapping and explain the potential benefits of implementing these procedures early in your clinical studies. Participants should be prepared to engage in interactive discussion of this issue.

Learning Objectives:
  1. Describe the concept of Quality by Design (QBD).
  2. Identify at least three factors that contribute to data quality failures.
  3. Apply concepts of Case Report Form mapping to enhance data integrity and reduce data collection inconsistencies.
 


 
 
Average Rating: (1 Rating)
  Was great, surpassed expectations, and I would recommend this
  Was good, met expectations, and I would recommend this
  Was okay, met most expectations
  Was okay but did not meet expectations
  Was bad and I would not recommend this
 



Submit
 
FDA Inspections: Understand the Process and Manage the Consequences
Remote Monitoring and Access to Electronic Medical Records
Advanced Monitoring Visit Documentation: Global Regulatory Authority Inspections and Sponsors
Clinical Trial Study Management Plans: The Architecture of a Quality Clinical Trial
CAPA Isn't Just a Compliance Tool: Maximizing Site Performance Applying CAPA Principles