Webinar · Palm Beach, Florida
Quality by Design-The Value of CRF Mapping
Education, Training · Business consulting
Key numbers
- Editions on record
- 1first in 2015
About Quality by Design-The Value of CRF Mapping
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
From our listing of this edition. Details may have changed since.
Editions
| Year | Dates | Where | Exhibitors | Visitors |
|---|---|---|---|---|
| 2015 | 19 Aug 2015 | Webinar Venue Online | — | — |
Past editions from the bvents archive (2008–2019) and organiser figures where they were published.
Questions
When is Quality by Design-The Value of CRF Mapping?
The next dates haven't been confirmed. The last edition we have on record was 19 Aug 2015.
Where is it held?
The last edition we have was at Webinar Venue, Palm Beach, Florida.