Title: Data Submission  
Owner: Former user
Creator: Former user Nov 05, 2020
Last Changed by: Alex Pearce Sept 27, 2024
Tiny Link: (useful for email) https://advance.hub.phuse.global/wiki/x/ggaZAQ
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    Page: BIMO: Requirements for Clinical Site Data and Subject Level Data Listings for FDA CDER's Inspection Process
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Sept 27, 2024 10:59 Alex Pearce View Changes
Sept 27, 2024 10:58 Alex Pearce View Changes
Sept 19, 2024 13:09 Nicola Newton View Changes
Sept 19, 2024 13:07 Nicola Newton View Changes
Apr 30, 2024 15:13 Alex Pearce  
Outgoing Links
External Links (33)
    https://www.fda.gov/media/88173/download
    english.nmpa.gov.cn
    https://www.fda.gov/media/153632/download
    https://www.fda.gov/drugs/electronic-regulatory-submission-…
    https://www.pmda.go.jp/english/review-services/reviews/0002…
    www.ema.europa.eu/docs/en_GB/document_library/Other/2013/04…
    https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProc…
    https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegul…
    https://www.fda.gov/regulatory-information/search-fda-guida…
    https://www.fda.gov/regulatory-information/search-fda-guida…
    www.phusewiki.org/wiki/images/f/f0/FDA_Data_Standards_Catal…
    https://www.fda.gov/media/76783/download
    www.cde.org.cn/news.do?method=largeInfo&id=7a43c3abfde95950
    https://phuse.s3.eu-central-1.amazonaws.com/Advance/Optimiz…
    https://stage.phuse.global/Deliverables
    https://www.fda.gov/downloads/ForIndustry/DataStandards/Stu…
    https://www.fda.gov/media/88120/download
    www.pmda.go.jp/files/000160658.pdf
    sbiaevents.com/files/eCTD-Study-Data-Standards-Webinar-Oct-…
    https://phuse.s3.eu-central-1.amazonaws.com/Deliverables/Op…
    https://github.com/phuse-org/phuse-scripts
    https://www.fda.gov/ForIndustry/DataStandards/StudyDataStan…
    https://www.cdisc.org/system/files/all/Education/CFDA_DataT…
    www.pmda.go.jp/files/000206451.pdf
    https://phuse.s3.eu-central-1.amazonaws.com/Advance/Powerpo…
    https://www.fda.gov/forindustry/datastandards/studydatastan…
    https://www.fda.gov/downloads/Drugs/Guidances/UCM292334.pdf
    www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/d…
    https://phuse.s3.eu-central-1.amazonaws.com/Deliverables/No…
    https://www.fda.gov/drugs/developmentapprovalprocess/formss…
    www.pmda.go.jp/files/000160019.pdf
    https://www.fda.gov/regulatory-information/search-fda-guida…
    https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProc…
WORKING GROUPS (2)     Page: Data Submission
    Page: BIMO: Requirements for Clinical Site Data and Subject Level Data Listings for FDA CDER's Inspection Process