Title: SEND Implementation FAQ  
Author: Troy Smyrnios Feb 24, 2021
Last Changed by: Troy Smyrnios Nov 16, 2023
Tiny Link: (useful for email) https://advance.phuse.global/x/aYJC
Export As: Word · PDF  
Incoming Links
SEND Implementation Forum (2)
    Page: SEND Implementation Forum - Archived Content
    Home page: SEND Implementation Forum Home
WORKING GROUPS (3)
    Page: SEND Implementation Wiki
    Page: SEND Implementation Wiki - Getting SEND-ready
    Page: The Roadmap for Nonclinical Data Standards and Elements to Improve Data Access
Hierarchy
Parent Page
    Page: SEND Implementation Wiki
Children (3)
    Page: SEND Implementation FAQ - Handling of SEND in Study Documentation
    Page: SEND Implementation FAQ - Known Issues
    Page: SEND Implementation FAQ - SEND Between Organizations
Labels
There are no labels assigned to this page.
Recent Changes
Time Editor  
Nov 16, 2023 14:52 Troy Smyrnios View Changes
Nov 16, 2023 14:51 Troy Smyrnios View Changes
Nov 16, 2023 14:41 Troy Smyrnios View Changes
Nov 16, 2023 14:32 Troy Smyrnios View Changes
Nov 16, 2023 14:21 Troy Smyrnios  
Outgoing Links
External Links (35)
    mailto:cber-edata@fda.hhs.gov
    mailto:submit@instem.com
    https://www.fda.gov/industry/study-data-standards-resources…
    mailto:cder-edata@fda.hhs.gov
    https://wiki.cdisc.org/pages/viewpage.action?pageId=6894952…
    senddataset.org/
    https://defineeditor.com/
    https://www.fda.gov/industry/fda-data-standards-advisory-bo…
    https://jira.cdisc.org/secure/Dashboard.jspa
    www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/uc…
    https://wiki.cdisc.org/display/PUB/Stylesheet+Library
    www.cdisc.org/send
    www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissio…
    www.fda.gov/forindustry/datastandards/studydatastandards/de…
    evs.nci.nih.gov/ftp1/CDISC/SEND
    https://github.com/phuse-org/phuse-scripts/tree/master/cont…
    www.fda.gov/ForIndustry/DataStandards/StudyDataStandards/de…
    https://phuse.s3.eu-central-1.amazonaws.com/Advance/Nonclin…
    estri.ich.org/eCTD/index.htm
    support.sas.com/software/products/univiewer/index.html
    https://phuse.global/Deliverables/1
    https://www.fda.gov/industry/fda-resources-data-standards/s…
    www.ema.europa.eu/docs/en_GB/document_library/Other/2013/04…
    evs.nci.nih.gov/ftp1/CDISC/SEND/
    https://www.fda.gov/forindustry/datastandards/studydatastan…
    https://github.com/phuse-org/phuse-scripts/tree/master/data…
    https://cosa.cdisc.org/
    evs.nci.nih.gov/ftp1/CDISC/SEND/Archive
    www.law.cornell.edu/uscode/text/21/379k-1
    https://www.federalregister.gov/documents/2018/01/23/2018-0…
    ncitermform.nci.nih.gov/?version=cdisc
    https://www.fda.gov/drugs/electronic-submissions-cder/elect…
    https://www.fda.gov/drugs/electronic-regulatory-submission-…
    https://www.fda.gov/regulatory-information/selected-amendme…
    https://www.pmda.go.jp/english/review-services/reviews/0002…
SEND Implementation Forum (2)     Page: SEND Implementation News
    Page: SEND Implementation Forum
WORKING GROUPS (10)     Page: SEND Implementation FAQ - Known Issues
    Page: SEND Implementation Wiki - CT Fundamentals
    Page: SEND Implementation FAQ - Handling of SEND in Study Documentation
    Page: Testing Simplified TS Examples Against FDA Technical Rejection Criteria
    Page: SEND Implementation FAQ
    Page: SEND Implementation Wiki - Define Fundamentals
    Page: The Roadmap for Nonclinical Data Standards and Elements to Improve Data Access
    Page: SEND Implementation FAQ - SEND Between Organizations
    Page: Investigating Endpoint Modeling - Biomarkers
    Page: SEND Implementation Wiki - SEND Fundamentals