· 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?