“Make sure you have the right to the research, the right to use the data… data traceability all the way through the process.”
BH
Bethany Hills
FDA Watch ·
“The data must be accurate, complete, and traceable back to the source to allow us to do source data verification.”
Meryl Dersarkissian · FDA Watch · The Rise of Real-World Evidence in Regulatory Strategy, Part 3: RWE in Accelerated Approvals
Play from 31:28
31:28
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What was described
Ensure real-world data fitness for use by confirming relevance, accuracy, completeness, traceability, and ability to perform source data verification
Said nearby on the same subject
“We've been using their data… I've tested almost every data source… they are the most accurate of the data providers out there”
♫
Said on Profiles in Risk
“Ensure and test the backup data, to ensure that it will work properly, that it can be retrieved easily if a failure occurs.”
♫
Said on Public Risk Management
“One of the findings of the study that I did for two years around farm data was the need for some type of farmer-owned data cooperative where the farmers controlled the data first and then controlled who had access to it and had the ability to monetize it.”
SB
Sherry Bunting
AgCulture Podcast ·
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