The FDA Federal Register Notice, 84 FR 43139, announcing the pilot https://www.federalregister.gov/documents/2019/08/20/2019-17877/fit-for-use-pilot-program-invitation-for-the-clinical-data-interchange-standards-consortium-for (this link was tested at the time of posting but will not be maintained if revised in the future, please access the FDA Federal Register web page.)
INDUSTRY FEEDBACK Learning Points & Takeaways:
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Individual Participant Feedback - a powerpoint slide deck with details from each pilot participants experience.
This slide deck begins with a summarized description of the pilot content (study types and designs) and the following information on participation:
Agency sought maximum of 5 participants with selection based specific guidelines.
•Received Requests: 9
•Accepted Requests: 5
•Studies Evaluated: 7
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Submission packages provided by participants (each zip file comprises one participants contribution)
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