Log in
Skip to sidebar
Skip to main content
PHUSE Advance Hub
Spaces
Hit enter to search
Help
Online Help
Keyboard Shortcuts
Feed Builder
What’s new
Available Gadgets
About Confluence
Log in
WORKING GROUPS
Page tree
Browse pages
Configure
Space tools
View Page
A
t
tachments (6)
Page History
Page Information
View in Hierarchy
View Source
Export to PDF
Export to Word
Pages
SEND Implementation Wiki
SEND Implementation FAQ
Page Information
Title:
SEND Implementation FAQ
Author:
user-61bac
Feb 24, 2021
Last Changed by:
user-61bac
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
user-61bac
View Changes
Nov 16, 2023 14:51
user-61bac
View Changes
Nov 16, 2023 14:41
user-61bac
View Changes
Nov 16, 2023 14:32
user-61bac
View Changes
Nov 16, 2023 14:21
user-61bac
View Page History
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
Overview
Content Tools
{"serverDuration": 97, "requestCorrelationId": "1323acccad63fbb2"}