Title: Data Submission  
Author: Wendy Dobson Nov 05, 2020
Last Changed by: Alex Pearce Apr 30, 2024
Tiny Link: (useful for email) https://advance.phuse.global/x/1QEF
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Hierarchy
Parent Page
    Page: SDTM ADaM Implementation FAQ
Children (1)
    Page: BIMO: Requirements for Clinical Site Data and Subject Level Data Listings for FDA CDER's Inspection Process
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Recent Changes
Time Editor  
Apr 30, 2024 13:13 Alex Pearce View Changes
Apr 30, 2024 13:12 Alex Pearce View Changes
Feb 21, 2024 14:22 Alex Pearce View Changes
Oct 30, 2023 12:31 Nicola Newton View Changes
Sep 12, 2023 15:37 Nicola Newton  
Outgoing Links
External Links (32)
    https://www.fda.gov/media/76783/download
    https://www.pmda.go.jp/english/review-services/reviews/0002…
    https://www.fda.gov/media/88120/download
    https://www.cdisc.org/system/files/all/Education/CFDA_DataT…
    www.pmda.go.jp/files/000160658.pdf
    https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProc…
    www.pmda.go.jp/files/000206451.pdf
    https://phuse.s3.eu-central-1.amazonaws.com/Deliverables/Op…
    https://www.fda.gov/downloads/ForIndustry/DataStandards/Stu…
    https://www.fda.gov/ForIndustry/DataStandards/StudyDataStan…
    https://www.fda.gov/regulatory-information/search-fda-guida…
    https://phuse.s3.eu-central-1.amazonaws.com/Advance/Optimiz…
    https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegul…
    https://www.fda.gov/forindustry/datastandards/studydatastan…
    www.pmda.go.jp/files/000160019.pdf
    www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/d…
    www.cde.org.cn/news.do?method=largeInfo&id=7a43c3abfde95950
    https://www.fda.gov/regulatory-information/search-fda-guida…
    https://www.fda.gov/downloads/Drugs/Guidances/UCM292334.pdf
    sbiaevents.com/files/eCTD-Study-Data-Standards-Webinar-Oct-…
    https://phuse.s3.eu-central-1.amazonaws.com/Deliverables/No…
    https://github.com/phuse-org/phuse-scripts
    https://phuse.s3.eu-central-1.amazonaws.com/Advance/Powerpo…
    https://www.fda.gov/drugs/electronic-regulatory-submission-…
    www.phusewiki.org/wiki/images/f/f0/FDA_Data_Standards_Catal…
    https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProc…
    https://stage.phuse.global/Deliverables/1
    www.ema.europa.eu/docs/en_GB/document_library/Other/2013/04…
    https://www.fda.gov/media/88173/download
    https://www.fda.gov/regulatory-information/search-fda-guida…
    english.nmpa.gov.cn
    https://www.fda.gov/drugs/developmentapprovalprocess/formss…
WORKING GROUPS (2)     Page: BIMO: Requirements for Clinical Site Data and Subject Level Data Listings for FDA CDER's Inspection Process
    Page: Data Submission