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AHI-CVM In-Person Raw Data WG Meeting
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First in-person meeting of the raw data WG.

11/12/2019
When: Tuesday, October 12
12:30 pm
Where: CVM Headquarters
7500 Standish Place
Rockville, Maryland  20855
United States
Contact: Kristen Stout-Diffenderfer


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Action Items:

 

·         The next working group meeting will take place on November 12th

·         Members from both industry and CVM will be prepared to answer the six questions outlined in the charter

·         How do sponsors qualify systems and vendors to have confidence in the data generated? 

·         How are underlying systems maintained within the companies?

·         How do studies using GxP standards increase confidence in the study results?

·         What are FDA concerns about data quality?

·         How is FDA’s confidence in the quality of the data linked to its mission to protect human and animal health?

·         How does submission quality impact the acceptability of study conduct?

·         Members will also be prepared to discuss the following points regarding raw data

·         What do members consider raw data?

·         How should raw data be categorized?

·         What is the burden in collecting and submitting raw data?